ABSTRACT
Introduction
In recent years, there has been a growing interest in integrating psychological treatments in primary care (PC) for individuals with emotional disorders (EDs), as an alternative to the pharmacological treatments typically offered. Transdiagnostic interventions, such as the Unified Protocol for the Treatment of EDs (UP), in brief group format, have emerged as a viable option for treating EDs in PC services. The aim of the present study was to compare the preliminary clinical utility and feasibility (adherence, quality, usefulness, satisfaction of the intervention, among others) of the UP applied in two group formats of 5 and 8 sessions in a PC setting.
Method
The sample consisted of 43 individuals (72.1% women) with a mean age of 40.7 years (SD = 10.77) treated in PC of the Spanish public health system who had a diagnosis of EDss and who were randomized to two treatment conditions: the 8‐session (n = 28) or the 5‐session (n = 15) UP group. The variables assessed pre‐ and posttreatment and at 1‐, 3‐ and 6‐month follow‐up were anxiety, depression, transdiagnostic emotional regulation dimensions, interference and quality of life.
Results
Over time, statistically significant changes were observed in all variables assessed in both conditions (except for positive temperament and social anxiety). No statistically significant differences were found between the two study conditions (except for traumatic re‐experiencing, with higher scores found in the 5‐session group), neither in adherence, quality, usefulness, satisfaction, or other feasibility variables, showing high scores in all of them.
Conclusion
The UP in a brief and group format, whether via 5 or 8 group sessions, could be clinically useful and a feasible proposal for addressing EDs in Spanish PC settings.
Trial Registration
Keywords: brief format, emotional disorder, group format, primary care, unified protocol
1. Introduction
In recent years, there has been a growing interest in seeking new and more cost‐effective psychological treatments for the Spanish National Health System (NHS) as a way of optimizing public mental health services. The main focus of interest is on primary care (PC) services, where there is a high demand for consultations by individuals with mental health problems (36.3% of the individuals treated present psychological problems; Base de Datos Clínicos de Atención Primara BDCAP 2022). This, combined with the lack of psychologists in these services (a total of 366 psychologists in Spanish PC services; Consejo General de la Psicología de España 2023), has led to the saturation of these centers.
In this regard, the most prevalent psychological problems in PC are emotional disorders (ED; anxiety, depressive and related disorders; Bullis et al. 2019) (Ministerio de Sanidad 2022). Therefore, PC services have clinical guidelines for psychological action to treat individuals with ED (Álvarez et al. 2023; Bulbena‐Vilarrasa et al. 2018). At a first general level, it is recommended that all professionals offer emotional support to all individuals who are treated at the center. At the second level, it is recommended to offer counseling when individuals are physically and emotionally overwhelmed. Finally, in cases where individuals present severe symptoms, it is recommended to offer structured psychological treatment. In this regard, the psychological treatment suggested by the clinical guidelines for EDs, is cognitive‐behavioral therapy (CBT) (Ministerio de Sanidad 2023). This intervention approach adopts a structured format that is limited in time and is traditionally based on cognitive‐behavioral models specific to each disorder. However, it is difficult to apply CBT in an individual format for each specific disorder in PC due to the high comorbidity of people with EDs (Allen et al. 2010) as well as the high volume of consultations for psychological problems (Base de Datos Clínicos de Atención Primara BDCAP 2022). In addition, the literature has shown that when applying a specific treatment for the primary disorder, full remission of the comorbid disorders is uncommon and tends to relapse over time (Borkovec et al. 1995; Brown et al. 1995). Furthermore, offering a wider range of treatments demands more extensive training for healthcare professionals, leading to higher training costs, as well as increased financial resources for implementation and maintaining treatment fidelity (McHugh and Barlow 2010; Wilamowska et al. 2010). For these reasons, pharmacological treatment is typically used as the first choice.
Various recent meta‐analyses have already studied the efficacy of psychological versus pharmacological treatment. Specifically, the study by Leichsenring et al. (2022) carried out an evaluation of 102 meta‐analyses and their results showed that combined treatment (psychological treatment and psychotropic drugs) was more effective than treatments applied on their own. In turn, no significant differences were found in short‐term efficacy between psychological and pharmacological treatment. However, in the long term, psychological treatment was more effective than pharmacological intervention for the treatment of EDs. These results are consistent with previous meta‐analyses, which suggest that CBT is more effective than pharmacological intervention for the treatment of EDs (Watts et al. 2015).
Despite these findings, pharmacological treatment is often used as first‐line treatment in countries where psychological treatment is difficult to access (Cipriani et al. 2018; Silverman and Teachman 2022). As a result, Spain has one of the highest rates of consumption of antidepressants and anxiolytics (IQVIA 2022). However, clinical guidelines recommend psychological intervention as the treatment of choice for most mental disorders, including psychotropic drugs only in more severe cases (National Institute for Health and Care Excellence NICE 2022). Furthermore, the administration of psychotropic drugs is associated with the occurrence of multiple adverse effects (Trejo‐Rosales 2022) that are often misinterpreted as new symptoms, leading to the administration of new psychotropic drugs and the chronification of the psychological disorder (Gøtzsche 2016). Also, this type of treatment is often administered to individuals with mild to moderate depression and/or anxiety symptoms or adjustment disorders, which leads to the medicalization of everyday problems, as well as a reduction in people's ability to cope effectively with stressful events (Gómez‐Esteban 2022).
For all these reasons, there is a commitment to incorporate new treatments, for example, transdiagnostic interventions (e.g., Norton 2012) and more cost‐effective formats of delivery, such as group format (e.g., Peris‐Baquero et al. 2023). The transdiagnostic approach is based on addressing transdiagnostic mechanisms, that is, factors associated with the etiology and maintenance of different disorders (e.g., neuroticism, rumination, avoidance) (Rosellini and Brown 2014; Sauer‐Zavala et al. 2017). Knowing these factors, it is possible to design a unique intervention to treat a range of disorders, for example, eating disorders (Fairburn et al. 2003), anxiety disorders (Norton 2012) or EDs (Barlow et al. 2018).
So far, different transdiagnostic interventions have been tested in the context of Spanish PC. A case in point is the study by Cano‐Vindel et al. (2022), which applied a transdiagnostic group CBT (TD‐GCBT). The TD‐GCBT consisted of seven group sessions applied every 2 weeks, over 12‐14 weeks. This intervention included therapeutic techniques such as psychoeducation, relaxation techniques, cognitive restructuring, behavioral techniques, problem‐solving techniques and relapse prevention. The total study sample consisted of 1,061 individuals with EDs, who were randomly assigned to the TD‐GCBT added to treatment as usual (TAU) condition (n = 527) or to the TAU condition (n = 534), which is based on pharmacotherapy and/or informal support offered by the PC physician. The findings showed better results in the TD‐GCBT condition for anxiety, depressive and somatic symptoms, and these were maintained over time (12‐month follow‐up).
Another treatment proposal within this approach is the “Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders” (UP; Barlow et al. 2018). The UP consists of eight treatment modules applied weekly over 12–16 individual sessions. The UP modules include: (1) motivation for change; (2) emotional psychoeducation; (3) training in emotional awareness; (4) cognitive flexibility; (5) countering emotional behaviors; (6) interoceptive exposure; (7) emotional exposure and (8) relapse prevention (Barlow and Farchione 2018). Modules 3, 4, 5, 6, and 7 are considered the core modules, which address transdiagnostic mechanisms related to the etiology and maintenance of EDs. The UP has been shown to be effective for EDs in numerous systematic reviews and meta‐analyses (Carlucci et al. 2021; Cassiello‐Robbins et al. 2020; Longley and Gleiser 2023; Sakiris and Berle 2019; Schaeuffele et al. 2024) and also when applied in group format (Ayuso‐Bartol et al. 2024), and specifically, in 12 group sessions in the Spanish NHS (Peris‐Baquero et al. 2023). Moreover, user evaluations highlight a high level of satisfaction with the treatment, with an average score of 8.41 out of 10 (SD = 1.17, Peris‐Baquero et al. 2023).
It is important to highlight the potential benefits of a brief version of the UP in a group format, particularly in the context of the PC in the Spanish public health system, given its focus on intervention with users presenting mild to moderate symptoms (with severe cases being referred to specialized mental health services), and due to the limited human and material resources available. In this regard, previous research has explored the usefulness of the UP in brief formats within PC settings in other countries (e.g., De Paul and Caver [2021] applied UP in five sessions). However, in Spain, so far only the study by Corpas et al. (2022) has applied the UP in this service. This intervention was adapted to a brief format of eight group sessions applied over 8 weeks, in which the therapeutic content of each session corresponded to a different module of the UP (as previously mentioned), without any modifications to the original structure. The total sample consisted of 105 participants, who were randomly assigned to brief group UP condition (n = 53) or TAU condition (n = 52), which consisted of pharmacotherapy. The results showed that the brief group UP led to statistically significant improvements from pre‐to posttreatment, with large effect sizes observed in clinical symptoms, including generalized anxiety, somatization disorder, panic disorder, and major depression. as well as in modifying cognitive processes (worry, rumination and metacognition) and emotional regulation strategies (cognitive reappraisal and expressive suppression). In addition, it proved to be more effective than TAU in the reduction of all EDs symptoms and diagnoses (except for generalized anxiety).
In line with the point of reducing the length of treatments, different studies indicate that the average number of sessions that individuals usually receive in PC is between two and three (Burguillos 2022; Sánchez‐Reales et al. 2015). Nonetheless, the findings show that most of the individuals treated were medically discharged due to clinical improvement, based on clinical judgment, within the first five sessions (Burguillos 2022). In accordance with this data, recent studies indicate the need for psychological interventions to be brief, especially in contexts such as PC, where individuals present mild‐moderate symptomatology (Cassiello‐Robbins et al. 2020). Likewise, it is recommended that treatments must be personalized so that the minimum dose necessary to achieve improvements in symptomatology is offered (Norcross and Wampold 2019). For this reason, brief transdiagnostic interventions and, specifically, the versatility of its application in group format and its adaptation to different contexts (Cassiello‐Robbins et al. 2020) makes the UP a viable option for use in Spanish PC settings.
Due to everything mentioned above, it is necessary to continue studying the most efficiency way to apply a cost‐effective intervention to treat the most prevalent disorders treated in PC settings in Spain, EDs (Ministerio de Sanidad 2022). The aim of this study is to compare the preliminary clinical utility and feasibility (adherence, intervention quality, usefulness and satisfaction of the intervention) of the UP applied in a group format of 5 and 8 sessions in a PC setting. Specifically, we expect to observe statistically significant differences in depression, anxiety, and related symptoms over time in both study conditions. Additionally, we anticipate finding statistically significant differences between conditions at each evaluation time, both in terms of clinical outcomes and feasibility variables. Specifically, we expect these results because, in the 5‐session format, we removed two modules of the UP, which reduces both the therapeutic content and the time available for interaction with the therapist and the group, as well as the time for practicing homework exercises between sessions. Additionally, efficacy data from the Corpas et al. (2022) study supports the 8‐session version. Therefore, our second hypothesis is that, although both versions will be effective, the 8‐session format will yield better results.
2. Methods
2.1. Participants
Initially, the sample included 51 participants, but due to scheduling issues, one of the 5‐session groups could not be conducted. As a result, the analysis was restricted to those who completed the pretreatment evaluation, leading to a final sample of 43 users (72.1% women) with a mean age of 40.7 years (SD = 10.77, range 18–59). All of them were treated in PC services, presented emotional symptomatology and met the following inclusion criteria: (1) To have at least one ED diagnosis (anxiety, depressive, obsessive‐compulsive, trauma and somatic disorders) from the ADIS‐5 interview; (2) To have a severity score between 0 and 5 (mild‐moderate) on the diagnoses on the CSR of the ADIS‐5; (3) To be able to attend all assessment and treatment sessions; (4) Individuals on pharmacological treatment will be asked to maintain the dosage for the duration of the study, unless there is a medical contraindication. Regarding exclusion criteria: (1) Absence of clinical diagnosis; (2) Presenting a diagnosis of ED with a severity score on diagnoses between 6 and 8 on the ADIS‐5 CSR (severe) or a clinical condition requiring specialized mental health intervention such as the presence of a severe mental disorder (e.g., personality disorder, bipolar disorder, or schizophrenia), suicide risk at the time of assessment, or substance use in the past 3 months; (3) Those who have received 8 or more sessions of CBT (during the past 5 years) with techniques such as cognitive flexibility or exposure; (4) Those receiving psychological treatment. Finally, they were randomized to the UP in group format in 5 sessions (n = 15) or 8 sessions (n = 28). The flow diagram of the participants can be seen in Figure 1 and the rest of the sociodemographic information can be found in Table 1.
Figure 1.

Flowchart of study participants following the CONSORT guidelines.
Table 1.
Socio‐demographic characteristics of the participants (N = 43).
| 5‐session UP group (n = 15) | 8‐session UP group (n = 28) | Comparison | Total (n = 43) | ||
|---|---|---|---|---|---|
| n (%) | n (%) | x2 | p | n (%) | |
| Gender | 0.38 | 0.561 | |||
| Women | 10 (66.7) | 21 (75.0) | 31 (72.1) | ||
| Men | 5 (33.3) | 7 (25.0) | 12 (27.9) | ||
| Educational level | 4.89 | 0.430 | |||
| More than 12 years of education | |||||
| University studies | 3 (20.0) | 7 (25.0) | 10 (23.3) | ||
| Vocational training | 7 (46.7) | 7 (25.0) | 14 (32,6) | ||
| High school | 1 (6.7) | 3 (10.7) | 4 (9.3) | ||
| Less than 12 years of education | |||||
| Primary studies or less | 3 (20.0) | 10 (35.7) | 13 (30.2) | ||
| Secondary studies | 1 (3.6) | 1 (2.3) | |||
| Marital status | 5.75 | 0.124 | |||
| Married/living with partner | 12 (80.0) | 14 (50.0) | 26 (60.5) | ||
| Single | 3 (20.0) | 6 (21.4) | 9 (20.9) | ||
| Separated/Divorced | — | 7 (25.0) | 7 (16.3) | ||
| Widowed | — | 1 (3.6) | 1 (2.3) | ||
| Job status | 8.89 | 0.064 | |||
| Not working | |||||
| Unemployed | 3 (20.0) | 2 (7.1) | 5 (11.6) | ||
| Sick leave | 4 (26.7) | 14 (50.0) | 18 (41.9) | ||
| Student | 3 (20.0) | 3 (7.0) | |||
| Home‐maker | — | 1 (3.6) | 1 (2.3) | ||
| Working | 5 (33.3) | 11 (39.3) | 16 (37.2) | ||
| Primary diagnoses | 6.08 | 0.414 | |||
| Anxiety and related disorders | |||||
| Generalized anxiety disorder | — | 3 (10,7) | 3 (7.0) | ||
| Panic disorder without agoraphobia | 2 (13.3) | 1 (3.6) | 3 (7.0) | ||
| Obsessive‐compulsive disorder | — | 1 (3.6) | 1 (2.3) | ||
| Illness anxiety disorder | 1 (6.7) | 1 (3.6) | 2 (4.7) | ||
| Mood disorders | |||||
| Major depressive disorder | 1 (6.7) | — | 1 (2.3) | ||
| Dysthymia | — | 1 (3.6) | 1 (2.3) | ||
| Mixed disorders | |||||
| Adjustment disorder | 11 (73.3) | 21 (75.0) | 32 (74.4) | ||
| Diagnostic comorbidity | 0.42 | 0.275 | |||
| Yes | 4 (26,7) | 4 (14.3) | 8 (18.6) | ||
| No | 11 (73.3) | 24 (85.7) | 35 (81.4) | ||
| Secondary diagnoses | 8.70 | 0.191 | |||
| Grief | 2 (13.3) | — | 2 (4.7) | ||
| Personality disorder traits | — | 2 (7.1) | 2 (4.7) | ||
| Other Specified Feeding and Eating Disorder (OSFED) | 1 (6.7) | — | 1 (2.3) | ||
| Dysthymia | — | 1 (3.6) | 1 (2.3) | ||
| Behavioral disturbance | 1 (6.7) | — | 1 (2.3) | ||
| Insomnia | — | 1 (3.6) | 1 (2.3) | ||
| Pharmacological treatment | 1.83 | .176 | |||
| Yes | 7 (46.7) | 19 (67.9) | 26 (60.5) | ||
| No | 8 (53.3) | 9 (32.1) | 17 (39.5) | ||
2.2. Procedure
This is a pilot feasibility study that was carried out in a PC setting associated with the Hospital Universitario de La Plana in Vila‐real and the Centro de Salud La Vall d'Uixó, both in Castellón, Spain. All those PC users evaluated by the PC physician and who presented as a reason for consultation an emotional complaint (mainly anxiety or depression symptomatology) and showed mild‐moderate scores (between 7 and 12) in the ODSIS and OASIS instruments were referred to this service. Cases referred to the clinical psychology specialist in PC were evaluated on the basis of the clinical diagnosis (ADIS‐5, Brown and Barlow 2014) and the ADIS‐5 CSR. Those mild cases not requiring intervention were referred back to the PC physician for follow‐up and those with a severe mental disorder or scores above 5 on the ADIS‐5 CSR were referred to specialized mental health services. In a similar way, those cases that, once evaluated in specialized mental health services, were considered mild cases, were referred to the psychology service in PC.
Those individuals who met the inclusion criteria were invited to participate in the study. After signing the informed consent form, they completed the initial assessment protocol in paper and pencil format. After this, a stratified randomization was performed based on the scores obtained in the ODSIS and OASIS instruments, with the aim that participants randomized to the two treatment conditions would be comparable in symptomatologic severity. Specifically, we used half a standard deviation above and below the clinical cut‐off point (10) established in the Spanish validation (Osma et al. 2019) to categorize participants into three severity levels: mild (scores 0–6), moderate (scores 7–12), and moderate‐severe (scores ≥ 13).
Once this was done, participants were randomized through the randomizer program to one of the two treatment conditions: the 8‐session UP group or the 5‐session UP group. The randomization process was carried out by an independent researcher who was not involved in the evaluation or the intervention. Some participants initially randomized to the 5‐session groups condition did not complete the pretreatment evaluation due to concerns about the scheduling options for conducting the group sessions and in the end the group could not be carried out. As a result, their data were excluded from the final sample of the study.
In both conditions, the content of the UP manual was worked following the second edition of the UP manual (Barlow et al. 2018). The 5‐session format was chosen to examine whether a shorter version of the UP could still provide clinical effectiveness while improving feasibility in PC. The 8‐session format, previously tested in Spanish PC, was used as a comparison to assess whether further reducing the session length could still lead to meaningful improvements. The content of the sessions for the two treatment conditions are shown in Table 2. In the 8‐session UP condition, each of the original eight treatment modules was worked on per week. In the 5‐session version, modules 1 (Motivation for change and commitment to treatment) and 8 (Achievement, maintenance, and relapse prevention) were removed and modules 6 and 7 (interoceptive and emotional exposure) were combined. The decision to reduce and combine these modules was based on a careful process involving both a UP expert and clinical judgment from different therapists. The expert guided the adaptation to ensure the core therapeutic elements of the UP remained intact, while the therapists, all trained and experienced in UP in group format, used their clinical expertise to ensure that the shortened content was still effective in addressing the treatment goals. The sessions were 2‐h long weekly group sessions. The groups were led by a therapist and co‐therapists, all trained in the UP and with prior experience in delivering it in group format. Finally, session‐by‐session supervision was provided for the first 5‐ and 8‐session groups by a therapist certified as UP trainer (level 3 of training). This supervision ensured the correct implementation of the intervention and provided guidance on addressing any issues or adjustments that arose during treatment. Finally, five PCevaluations were carried out, at pretreatment, posttreatment and follow‐ups at 1, 3 and 6 months. These evaluations were completed in person, in a paper‐and‐pencil format, self‐administered by the participants, collected by the therapists, and subsequently anonymized and sent to the research team.
Table 2.
Contents of the sessions of the two treatment conditions.
| 5‐session UP condition | 8‐session UP condition |
|---|---|
| Session 1. Understanding emotions (module 2) | Session 1. Setting goals and maintaining motivation (module 1) |
| Session 2. Mindful emotion awareness (module 3) | Session 2. Understanding emotions (module 2) |
| Session 3. Cognitive flexibility (and problem solving) (module 4) | Session 3. Mindful emotion awareness (module 3) |
| Session 4. Countering emotional behaviors (module 5) | Session 4. Cognitive flexibility (and problem solving) (module 4) |
| Session 5. Interoceptive and emotional exposure (module 6 and 7) | Session 5. Countering emotional behaviors (module 5) |
| Session 6. Understanding and confronting physical sensations (module 6) | |
| Session 7. Emotion Exposures (module 7) | |
| Session 8. Recognizing Accomplishments and Looking to the Future (module 8) |
2.3. Instruments
2.3.1. Socio‐Demographic Data Questionnaire and Number of Treatment Sessions Received
It includes information on age, gender, educational level, marital status, job status, main and secondary psychological diagnosis according to ADIS‐5 diagnostic interview (Brown and Barlow 2014) and pharmacological treatment.
2.3.2. Anxiety and Related Disorders Interview Schedule for DSM‐5‐Adult Version (ADIS‐5; Brown and Barlow 2014)
It is a structured interview to diagnose current anxiety, mood, obsessive‐compulsive, trauma and related disorders (e.g., somatic symptoms, substance use) according to DSM‐5 criteria (American Psychiatric Association 2013). The ADIS‐5 also contains screening questions for a range of other disorders and Clinical Severity Rating (CSR), which consists of the therapist's clinical assessment of the severity of clinical diagnoses on a 9‐point scale (0: not at all; 1–2: mildly disruptive and disabling; 3–5: clearly disruptive and disabling; 6–7: markedly disruptive and disabling; 8: very disruptive and disabling).
2.3.3. Overall Depression Severity and Impairment Scale (ODSIS; Bentley et al. 2014; Osma et al. 2019)
It is an instrument that assesses depressive symptomatology during the past week by means of five items with a 5‐point Likert‐type response scale (0 = Little/Not at all; 4 = Extreme). The scores of the instrument in the present sample presented internal consistency values of Cronbach's alpha 0.90.
2.3.4. Overall Anxiety Severity and Impairment Scale (OASIS; Norman et al. 2006; Osma et al. 2019)
This instrument assesses anxious symptomatology during the past week through five items with a 5‐point Likert‐type response scale (0 = Little/Not at all; 4 = Extreme). The scores of the instrument in the present sample presented internal consistency values of Cronbach's alpha 0.82.
2.3.5. Multidimensional Emotional Disorders Inventory (MEDI; Rosellini and Brown 2019; Osma et al. 2023)
This is a self‐administered inventory that assesses nine transdiagnostic dimensions of emotional disorders: MEDI_neurotic temperament (MEDI_Neurotic Temperament), positive temperament (MEDI_Positive Temperament), depressed mood (MEDI_ Depressed Mood), autonomic arousal (MEDI_Autonomic Arousal), somatic anxiety (MEDI_Somatic Anxiety), intrusive cognitions (MEDI_Intrusive Cognitions), social concerns (MEDI_Social Concerns), traumatic re‐experiencing (MEDI_Traumatic re‐experiencing), and avoidance (MEDI_Avoidance), through forty‐nine items with a 9‐point Likert‐type response scale (0 = Not characteristic of me; 8 = Totally characteristic of me). The scores of the instrument in the present sample presented internal consistency values of Cronbach's alpha from 0.68 to 0.89.
2.3.6. Difficulties in Emotional Regulation Questionnaire (DERS; Gratz and Roemer 2004; Hervás and Jódar 2008)
This instrument assesses emotional dysregulation through twenty‐eight items, which uses a 5‐point Likert‐type response scale (1 = Almost never; 5 = Almost always). The total score of the instrument was used for this study. The scores of the instrument in the present sample presented internal consistency values of Cronbach's alpha 0.91.
2.3.7. Euroqol 5D (EQ‐5D; Brooks 1996; Badia et al. 1999)
This measure assesses current health‐related quality of life. Specifically for this study, the visual analog scale (EQ‐VAS) was used as in other studies (Derrett et al. 2009), using a score from 0 to 100 (0 = worst imaginable state of health; 100 = best imaginable state of health). The internal consistency of the instrument could not be calculated since only the visual analog scale was used.
2.3.8. Maladjustment Inventory (MI) (Echeburúa et al. 2000; Osma et al. 2024)
The instrument assesses interference and consists of six items with a 6‐point Likert‐type response scale (0 = Not at all; 5 = Extremely). The scores of the instrument in the present sample presented internal consistency values of Cronbach's alpha 0.81.
2.3.9. Treatment Satisfaction Questionnaire (STQ; adapted from the Client Satisfaction Questionnaire [CSQ‐8] of Larsen et al. 1979)
The instrument includes seven questions, derived from 6 of the 8 original CSQ‐8 items (perceived quality, appropriateness to previous expectations, recommendation to friends or family, usefulness of techniques learned, overall satisfaction with the intervention, and likelihood of choosing this type of intervention again), with the addition of a question regarding the discomfort generated by the intervention. Participants respond to each question using 4‐point Likert‐type response scale (1 = nothing; 4 = very much): (1) How would you rate the quality of the treatment program you received?; (2) Did you find the kind of psychological intervention you were looking for?; (3) If a friend or family member needed similar help, would you recommend our treatment program?; (4) Has the content you have learned helped you cope more effectively with your problems?; (5) Overall, how satisfied are you with the treatment program you received?; (6) To what extent has this treatment program caused you discomfort?; (7) If you had to seek help again, would you choose a group treatment program? The scores of the instrument in the present sample presented internal consistency values of Cronbach's alpha 0.76.
2.4. Data Analysis
The sample size for the pilot study was calculated based on guidelines for pilot studies (Bell et al. 2018), aiming for a minimum of 20 participants (10 per condition) to achieve effect sizes between 0.3 and 0.7 and 80% statistical power. This was in line with recommendations for pilot studies to ensure adequate preliminary data for the subsequent larger‐scale RCT.
First, descriptive statistical analyses were carried out to explore the characteristics of the sample. Next, comparisons between conditions were conducted for sociodemographic variables. Specifically, Chi‐square tests were used for categorical variables, while Student's t‐tests were applied to continuous variables. Additionally, t‐tests and chi‐square tests were conducted to explore potential statistically significant differences between participants who dropped out and those who completed the intervention.
Finally, linear mixed models were carried out to analyse, on the one hand, through the main effects of “time,” whether there were statistically significant changes as the treatment progressed, then, the main effects of the variable “Condition” to examine statistically significant differences between conditions and, finally, the interaction effect “Time*Condition” with the aim of studying the differential evolution of scores over time as a function of condition. These models account for between‐subject variability and optimize comparisons more efficiently. Specifically, they allow for the inclusion of Bonferroni correction in the analyses, adjusting p values across multiple comparisons to control for Type I errors, thereby minimizing the risk of false positives when conducting multiple tests simultaneously. Additionally, the model included an analysis of the main effect of “initial severity”, based on severity ranges from the ODSIS and OASIS used for stratified randomization, as well as interaction effects (Time*Condition*Initial Severity) to examine whether score trajectories varied according to initial severity and treatment condition. Finally, the results also included Cohen's d effect sizes, interpreted as small (d ≈ 0.2), medium (d ≈ 0.5), or large (d ≈ 0.8). All the statistical analyses were carried out using the statistical software SPSS (V.25.0) (IBM Corp 2017).
3. Results
3.1. Sociodemographic Differences in Study Outcomes Between Treatment Conditions
The mean scores and standard deviations of the variables under study throughout the intervention can be seen in Table 3. The results of the Chi‐square analyses and T‐student test showed no statistically significant differences between treatment conditions in sociodemographic variables under study (p > 0.05). The results also revealed a diagnostic comorbidity rate of 18.6%, with no significant differences between conditions (see Table 1).
Table 3.
Means, standard deviations between groups results (N = 43).
| UP Group | Normative dataa | Pre‐T | Post‐T | 1‐MFU | 3‐MFU | 6‐MFU | |
|---|---|---|---|---|---|---|---|
| M (SD) | M (SD) | M (SD) | M (SD) | M (SD) | M (SD) | ||
| ODSIS | 5‐session | 2.79 (4.06) | 10.14 (5.36) | 9.78 (4.94) | 8.67 (5.2) | 7.00 (4.65) | 8.50 (6.28) |
| 8‐session | 10.59 (4.53) | 6.42 (4.68) | 6.58 (5.20) | 6.64 (5.39) | 5.10 (4.46) | ||
| OASIS | 5‐session | 3.92 (4.13) | 11.64 (4.09) | 9.00 (5.66) | 9.50 (5.08) | 6.83 (3.37) | 8.67 (5.86) |
| 8‐session | 12.19 (3.77) | 9.25 (4.05) | 8.25 (4.31) | 8.09 (4.18) | 6.50 (4.70) | ||
| MEDI_Neurotic Temperament | 5‐session | 17.97 (8.86) | 28.36 (7.95) | 28.22 (7.71) | 24.2 (7.42) | 26.17 (8.38) | 25.17 (8.97) |
| 8‐session | 28.04 (8.43) | 25.67 (8.09) | 26.33 (8.19) | 27.00 (6.40) | 25.36 (7.19) | ||
| MEDI_Positive Temperament | 5‐session | 28.49 (6.51) | 25.21 (8.77) | 23.11 (7.20) | 23.22 (10.32) | 22.33 (10.05) | 27.33 (8.86) |
| 8‐session | 22.04 (7.68) | 23.27 (6.51) | 24.17 (5.84) | 22.91 (6.52) | 26.60 (7.56) | ||
| MEDI_ Depressed Mood | 5‐session | 9.02 (8.46) | 25.43 (9.62) | 22.78 (9.31) | 19.40 (8.15) | 19.00 (6.63) | 18.83 (14.12) |
| 8‐session | 22.85 (8.18) | 17.42 (10.20) | 17.58 (8.93) | 18.73 (10.98) | 15.50 (11.01) | ||
| MEDI_Autonomic Arousal | 5‐session | 7.45 (7.74) | 24.71 (11.18) | 22.11 (10.06) | 14.30 (10.07) | 17.50 (8.74) | 18.17 (13.32) |
| 8‐session | 19.41 (8.79) | 15.92 (8.99) | 13.50 (7.67) | 12.70 (8.34) | 12.30 (9.65) | ||
| MEDI_Somatic Anxiety | 5‐session | 13.34 (7.68) | 24.64 (10.62) | 25.44 (6.86) | 20.78 (5.47) | 22.83 (4.17) | 18.00 (6.13) |
| 8‐session | 23.00 (8.45) | 20.83 (8.94) | 21.08 (9.15) | 22.00 (6.87) | 18.05 (8.98) | ||
| MEDI_Social Concerns | 5‐session | 13.88 (10.22) | 20.00 (11.97) | 19.78 (11.08) | 19.50 (7.65) | 19.00 (11.15) | 16.17 (6.97) |
| 8‐session | 20.96 (11.65) | 16.42 (9.69) | 17.17 (10.07) | 17.00 (9.65) | 15.20 (11.5) | ||
| MEDI_Intrusive Cognitions | 5‐session | 9.98 (9.99) | 27.93 (15.46) | 25.89 (15.92) | 20.70 (11.13) | 19.33 (10.37) | 21.00 (17.71) |
| 8‐session | 23.85 (14.22) | 20.75 (9.47) | 21.33 (11.15) | 22.45 (12.75) | 18.70 (11.30) | ||
| MEDI_Traumatic Re‐Experiencing | 5‐session | 7.11 (7.99) | 25.71 (12.75) | 21.89 (12.88) | 19.30 (8.63) | 18.33 (10.82) | 19.00 (11.19) |
| 8‐session | 16.96 (10.94) | 14.42 (9.79) | 15.75 (11.92) | 14.82 (10.01) | 11.80 (9.78) | ||
| Medi_Avoidance | 5‐session | 19.64 (10.93) | 41.14 (15.23) | 36.11 (16.07) | 27.80 (12.10) | 28.33 (5.72) | 31.33 (5.43) |
| 8‐session | 31.37 (10.46) | 27.25 (12.73) | 27.92 (15.27) | 27.91 (14.17) | 26.20 (16.00) | ||
| DERS | 5‐session | 58.40 (17.60) | 91.21 (27.82) | 81.50 (23.71) | 83.90 (27.80) | 84.33 (21.17) | 86.67 (25.76) |
| 8‐session | 85.30 (18.84) | 80.67 (20.72) | 77.18 (16.52) | 72.91 (20.58) | 66.78 (13.10) | ||
| Euroqol | 5‐session | 7.56 (1.66) | 5.16 (1.46) | 6.19 (1.65) | 6.65 (1.81) | 6.33 (1.99) | 5.25 (2.18) |
| 8‐session | 4.94 (2.20) | 4.77 (2.45) | 6.09 (1.69) | 6.39 (2.07) | 6.54 (1.89) | ||
| MI | 5‐session | 8.56 (6.98) | 19.64 (6.57) | 17.67 (6.73) | 17.00 (6.63) | 15.50 (6.92) | 15.33 (8.75) |
| 8‐session | 19.65 (5.31) | 16.67 (6.64) | 16.36 (7.24) | 16.36 (8.42) | 12.28 (8.85) |
Abbreviations: DERS, Difficulties in Emotional Regulation Questionnaire; MFU, month of follow‐up; MI, Maladjustment Inventory; OASIS, Overall Anxiety Severity and Impairment Scale; ODSIS, Overall Depression Severity and Impairment Scale.
Additionally, no statistically significant differences (p > 0.05) were found in any of the sociodemographic or psychological variables between participants who dropped out and those who completed the intervention.
3.2. Evolution of Scores Over Time Through the Main Effect of “Time” in Linear Mixed Models
The results of the linear mixed models showed a statistically significant main effect of time, with moderate to large effect sizes, on the variables ODSIS (F = 5.78, p < 0.001, dof = 85.54, Cohen's d = 0.79), OASIS (F = 11.17, p < 0.001, dof = 87.65, Cohen's d = 1.09), MEDI_Neurotic Temperament (F = 5.44, p = 0.001, dof = 82.37, Cohen's d = 0.76), MEDI_Depressed Mood (F = 6.00, p < 0.001, dof = 90.31, Cohen's d = 0.80), MEDI_Autonomic Arousal (F = 8.54, p < 0.001, dof = 84.73, Cohen's d = 0.96), MEDI_Somatic Anxiety (F = 3.57, p = 0.010, dof = 82.81, Cohen's d = 0.62), MEDI_Intrusive Cognitions (F = 4.43, p = 0.003, dof = 84.49, Cohen's d = 0.69), MEDI_Traumatic Re‐Experiencing (F = 4.22, p = 0.004, dof = 84.53, Cohen's d = 0.67), MEDI_Avoidance (F = 8.80, p < 0.001, dof = 84.07, Cohen's d = 0.97), DERS (F = 4.17, p = 0.004, dof = 80.24, Cohen's d = 0.67), Euroqol (F = 3.87, p = 0.006, dof = 81.93, Cohen's d = 0.64) and MI (F = 5.85, p < 0.001, dof = 84.53, Cohen's d = 0.79).
3.3. Evolution of Scores Over Time Through the Main Effect of “Condition” and Interaction Effect “Time*Condition” in Linear Mixed Models
As for the main effect of “Condition”, it was only found in the MEDI_Traumatic re‐experiencing (F = 4.07, p = 0.050, dof = 41.07, Cohen's d = 0.66), with higher scores found in the 5‐session group. The results did not show any other main effect of the “Condition”. Regarding the interaction effect of Time*Condition, no significant results were founds (p > 0.05). In addition, the effect sizes for this interaction were small to medium, with Cohen's d values ranging from 0.14 to 0.46, with the largest effects observed for the ODSIS and OASIS variables.
3.4. Evolution of Scores Over Time Through the Main Effect of “Initial Severity” and Interaction Effect “Time*Condition*Initial Severity” in Linear Mixed Models
The results of the linear mixed models showed a statistically significant main effect of “initial severity” on the outcomes, with moderate to large effect sizes for the variables ODSIS (F = 13.98, p < 0.001, dof = 37.04, Cohen's d = 1.22), OASIS (F = 14.43, p < 0.001, dof = 38.83, Cohen's d = 1.24), MEDI_Depressed Mood (F = 6.87, p = 0.003, dof = 33.76, Cohen's d = 0.86), MEDI_Autonomic Arousal (F = 7.02, p = 0.003, dof = 31.62, Cohen's d = 0.86), MEDI_Intrusive Cognitions (F = 4.09, p = 0.027, dof = 84.49, Cohen's d = 0.66), MEDI_Traumatic Re‐Experiencing (F = 3.82, p = 0.032, dof = 32.31, Cohen's d = 0.64), MEDI_Avoidance (F = 4.67, p = 0.016, dof = 84.07, Cohen's d = 0.71), DERS (F = 17.32, p < 0.001, dof = 30.42, Cohen's d = 1.36), Euroqol (F = 9.38, p < 0.001, dof = 39.92, Cohen's d = 1.00) and MI (F = 10.84, p < 0.001, dof = 34.55, Cohen's d = 1.08). However, no statistically significant “Time*Condition*Initial Severity” interaction effect was found for any variable (p > 0.05), although estimated effect sizes ranged from moderate (d = 0.74) to large (d = 1.32), with the highest observed for MEDI_Traumatic Re‐Experiencing.
3.5. Feasibility Results in the 5‐Session and 8‐Session UP Conditions
Regarding the feasibility results, no statistically significant differences were found between groups in treatment retention. Specifically, no significant differences were observed in posttreatment dropout (χ² = 1.15; p = 0.284) or at any other assessment point during follow‐ups (p > 0.05). Furthermore, no differences were noted in other feasibility variables, including perceived quality, alignment with previous expectations, recommendation to friends or family, usefulness of the techniques learned, overall satisfaction with the intervention, likelihood of choosing this type of intervention again, and discomfort generated by the intervention. Additionally, as shown in Table 4, participants in both conditions reported high scores in these variables.
Table 4.
Means, standard deviations, and between‐group comparisons based on the Treatment Satisfaction Questionnaire (STQ; an adaptation of the Client Satisfaction Questionnaire, CSQ‐8; Larsen et al. 1979).
| 5‐session UP group | 8‐session UP group | Comparison | Total | |
|---|---|---|---|---|
| M (SD) | M (SD) | |||
| 1) How would you rate the quality of the treatment program you received? | 3.56 (0.73) | 3.00 (0.95) | t = −0.10, p = 0.919 | 3.57 (0.60) |
| 2) Did you find the kind of psychological intervention you were looking for? | 3.33 (0.87) | 3.75 (0.45) | t = 0.82, p = 0.420 | 3.14 (0.91) |
| 3) If a friend or family member needed similar help. Would you recommend our treatment program? | 3.78 (0.44) | 3.33 (0.78) | t = 0.14, p = 0.890 | 3.76 (0.44) |
| 4) Has the content you have learned helped you to cope more effectively with your problems? | 3.11 (0.60) | 3.42 (0.52) | t = −0.71, p = 0.486 | 3.24 (0.7) |
| 5) Overall. How satisfied are you with the treatment program you received? | 3.44 (0.73) | 1.58 (0.52) | t = 0.10, p = 0.919 | 3.43 (0.6) |
| 6) To what extent has this treatment program caused you discomfort? | 1.67 (0.71) | 3.17 (0.72) | t = 0.31, p = 0.758 | 1.62 (0.59) |
| 7) If you had to seek help again. Would you choose a group treatment program? | 3.44 (0.53) | 3.17 (0.72) | t = 0.98, p = 0.341 | 3.29 (0.64) |
4. Discussion
The aim of this study was to analyse the feasibility and clinical utility of UP applied in a group format of 5 and 8 sessions in a PC setting. As hypothesized, on the one hand, we expected to find statistically significant reductions in symptoms of depression, anxiety, changes in dimensions that characterize EDs (MEDI), and also reductions in difficulties in emotional regulation and interference and improvements in quality of life in both study conditions, and on the other hand, we expected to find statistically significant differences between conditions at each evaluation time, in favor of the 8‐session condition.
The results obtained in the present study support the first hypothesis. Specifically, statistically significant reductions are observed in the variables evaluated in both the 5 and 8‐session conditions. Specifically, substantial improvements were observed, with moderate to large effect sizes, in emotional symptomatology (depression and anxiety symptoms assessed by the ODSIS and OASIS), as well as in other variables directly linked to the etiology and maintenance of EDS, such as negative and positive temperament (evaluated through the MEDI) and emotional regulation difficulties (assessed by the DERS). These variables would be considered vulnerability factors in the onset and persistence of EDs, according to the functional model theory of EDs (Barlow et al. 2021). Finally, these changes were maintained in the long term (at the 6‐month follow‐up). Nonetheless, all participants showed scores above the normative average at baseline, posttreatment, and follow‐up. Despite this, the results of this study show that an intervention based on a transdiagnostic approach and applied in an intensive, brief, group format can obtain, with only 5 or 8 weeks of treatment, clinical improvements in symptomatology. In this regard, it should be noted that 49.2% of people seen in PC services present mild to moderate symptoms of anxiety and depression (Consejo General de la Psicología de España 2019), so this type of intervention could allow a large number of people to be treated quickly and effectively, reducing their discomfort and avoiding the chronification of their problems. In addition, it would reduce waiting lists in specialized mental health services, optimizing the resources available in these services to care for people with clinically more severe symptomatology. Finally, the results obtained in this study are consistent with those obtained in previous studies, such as that of Cano‐Vindel et al. (2022), where a transdiagnostic group therapy was applied in seven sessions and the study by Corpas et al. (2022), where the UP was applied in eight sessions.
Another of the results obtained in this study is that changes have also been obtained in other clinical variables directly related to EDs. Specifically, changes have been observed in the variables of neurotic temperament, autonomic activation, cognitive intrusions, somatic anxiety, traumatic re‐experiencing, avoidance (assessed through the MEDI instrument), as well as in emotional regulation, quality of life and interference, with a trend toward improvement. These findings show that, in addition to improving anxious and depressive symptomatology, improvements are also obtained in transdiagnostic dimensions, some of them associated with the etiology and maintenance of EDs, such as neuroticism, autonomic activation (i.e., anxiety sensitivity) and avoidance (Rosellini and Brown 2019). In this regard, the application of this treatment allows for improvements in the emotional regulation skills of the people treated in PC, reducing the avoidance behaviors that sustain the problem, increasing tolerance to discomfort and reducing the interference that this symptomatology causes them.
In addition, the preliminary results from our study indicate that the UP, a transdiagnostic intervention delivered in a group and intensive format, allows simultaneous treatment of people with different specific problems, as well as those with diagnostic comorbidity, which was found to be 18.6% in our study. This suggests that such an intervention could contribute to the proper functioning of PC services that are currently saturated by a large volume of people with mental health problems seeking care (Base de Datos Clínicos de Atención Primara BDCAP 2022). Moreover, transdiagnostic treatments like the UP can help reduce training costs for therapists, as they do not need to specialize in different protocols for each specific diagnosis (Wilamowska et al. 2010). Additionally, they lower implementation and dissemination costs, given that the UP is a structured and protocolized treatment (McHugh and Barlow 2010).
In terms of previous studies carried out with the UP in Spanish PC settings, the results of the present study are mostly consistent with the findings of the study by Corpas et al. (2022), which applied the UP in 8 sessions in a group format and the results showed statistically significant differences in pre/post treatment scores for all measures assessed with high effect sizes. However, this study provides novel results on how UP, in a brief format of 5 sessions, can obtain improvements in the emotional symptomatology of individuals which did not differ significantly from those observed in the 8‐session format. Furthermore, it provides information on improvements in variables such as neuroticism, autonomic activation, somatic anxiety, traumatic re‐experiencing, avoidance, quality of life and interference, both in five and eight sessions.
These outcomes become more relevant if we consider the recommendations of international clinical guidelines, which advise offering brief psychological interventions based on CBT to individuals with EDs (World Health Organisation 2023), and even more so considering the context of PC, where users receive, on average, two to three treatment sessions (Burguillos 2022; Sánchez‐Reales et al. 2015). Therefore, a reduced number of transdiagnostic psychological treatment sessions applied at weekly frequency could be an effective treatment to improve the symptomatology of individuals treated in PC centers and to optimize the healthcare resources of the Spanish NHS.
On the other hand, it is worth mentioning those variables in which no statistically significant changes have been obtained after the application of the treatment in 5 and 8 sessions. The results of this study do not show improvements in positive temperament in any of the conditions, although previous studies did show improvements in this dimension when the UP was applied in 12 sessions in specialized mental health services (Peris‐Baquero et al. 2023). However, a possible explanation is that the participants' scores on positive temperament are within the normative range of scores in the community population (M = 28.49, SD = 6.51, Osma et al. 2023). In addition, no statistically significant changes in social anxiety symptoms were obtained, which could be associated with the characteristics of the study sample, since none of the participants had this type of problem.
Regarding the second hypothesis on whether there would be differences between the two study conditions, in favor of the 8‐session condition, the results obtained in the study do not support the second hypothesis. First, no statistically significant differences were observed in any socio‐demographic variable. Similarly, no statistically significant differences were found between the two intervention formats, except for trauma, where the participants in the 5‐session group presented higher scores than those in the 8‐session group, especially pretreatment. A similar result was observed in the avoidance variable, where participants in the 5‐session group started with significantly higher scores than the 8‐session group, and these differences were also present at the 6‐month follow‐up. These findings suggest that participants in the 5‐session group exhibited a slightly more severe profile on these variables compared to those in the 8‐session group.
Despite these results, no statistically significant differences were observed in the evolution of these variables or in any other based on the condition (Time * Condition interaction effect), and no statistically significant “Time * Condition * Initial Severity” interaction effects were found. However, effect sizes for these interactions were small to large, suggesting potential trends that may not have reached statistical significance due to limited power. Additionally, a main effect of initial severity on scores was observed. This indicates that, although there were initial differences in scores, both the 5‐session and 8‐session UP conditions led to long‐term outcomes that did not differ significantly, with scores progressing similarly across all assessment points. Given that no statistically significant differences were observed between the two formats, the 5‐session model may offer greater benefits, as it requires fewer resources. This approach aligns with the stepped‐care model, which prioritizes delivering the most effective treatment based on the available resources. Despite the reduction in modules and therapy time, the 5‐session UP condition retained the five core modules that focus on key skills. This suggests that both versions of the intervention were sufficiently effective for this profile of patients, even when using a reduced number of sessions. Despite all mentioned above, the sample of the present study included patients with mild to moderate symptoms, which may have contributed to the absence of significant differences between the two conditions. Moreover, the limited sample size may have reduced the statistical power to detect small or clinically relevant differences. For this reason, further research with larger sample sizes and longer follow‐up periods is necessary to better understand the efficacy of the Unified Protocol in brief formats, such as the 5‐ and 8‐session versions.
Finally, no differences were found between the two conditions in terms of feasibility results, including treatment retention, perceived quality, appropriateness to previous expectations, recommendation to friends or family, usefulness of techniques learned, overall satisfaction with the intervention, likelihood of choosing this type of intervention again, and discomfort generated by the intervention. It is important to note that participants in both conditions reported high scores on these variables. This finding is in line with satisfaction results obtained in the study conducted by Peris‐Baquero et al. (2023) and is particularly relevant given the direct link between treatment satisfaction, adherence, and effectiveness (Geers et al. 2013; Smith et al. 2013). These findings highlight the importance of implementing well‐rated interventions in PC settings.
Based on the results obtained and the recommendations of international clinical guidelines, implementing brief transdiagnostic psychological interventions in healthcare contexts could be a step towards adapting psychological treatments to the characteristics of PC care, given that this is characterized by treating individuals with mild‐moderate emotional symptomatology who receive psychological discharge after receiving a very limited number of sessions (Burguillos 2022). In addition, psychologists working in PC settings could offer the UP in 5 or 8 group sessions to patients considering also personal aspects, such as time limitations because of work or family responsibilities, without affecting the effectiveness of the intervention. In turn, the results of the study highlight again the versatility of the UP, as it has previously demonstrated its effectiveness in other contexts and in different formats (e.g., Cassiello‐Robbins et al. 2020). For all these reasons, the UP in a brief and intensive format, whether through 5 or 8 group sessions, could be a feasible and clinical useful proposal to be applied in PC services.
5. Limitations
This study has a series of limitations, first, it is a pilot feasibility study, so the sample size is limited (n = 43). In this same line, we should mention that there was a greater number of participants in the 8‐session UP group as, for scheduling reasons, some of the groups of 5 sessions initially proposed could not be conducted. Specifically, one of the planned 5‐session groups was canceled after several participants assigned to that group dropped out before the intervention began. Although stratified randomization based on ODSIS and OASIS scores was performed for these participants as with the rest of the sample, the low number of remaining participants made it unfeasible to carry out the group at that time, despite these individuals initially being considered part of the sample, so there was a greater number of groups of eight sessions (two groups of five sessions vs. four groups of eight sessions). This limitation may have conditioned the results obtained for each of the conditions and it may also affect the statistical power obtained. Specifically, the small sample size and unequal group sizes could have resulted in insufficient statistical power, which could explain the absence of differences between conditions. In addition, although the ADIS‐5 diagnostic interview was used in the pretreatment evaluation, it could not be used in the posttreatment or follow‐up due to the limited time available for PC psychologists. In this same line, due to limited human and material resources in the PC context, a nonstructured interview was used for the assessment of severe mental disorders. Future studies should have a larger number of participants and should include the evaluation of clinical diagnoses at the different evaluation points, as well as structured interviews for the assessment of severe mental disorders. Furthermore, future studies should also include the structured collection of additional information related to feasibility, such as participants' opinions on the duration of the intervention. Secondly, the findings of this study are preliminary data from a pilot study conducted in PC services of the Spanish NHS, so the results may not be generalizable to other contexts or to PC services in other countries. Finally, although no statistically significant differences were observed between the two conditions, future randomized clinical trials including long‐term follow‐ups should analyse in depth which intervention modality is best adapted to the characteristics of a given participant profile, with the aim of personalizing the duration or type of treatment to the characteristics and severity of users, while ensuring the most efficient use of resources through a stepped‐care approach.
6. Conclusions
The results of this study have shown, first, the feasibility of two brief versions of the UP, applied in a group format of 5 and 8 sessions in PC settings in Spain and, second, the preliminary clinical utility of both interventions in reducing mild‐moderate emotional symptoms, together with improving other variables closely related to the origin and maintenance of EDs. Then, these adaptations of the UP in group, intensive and brief, could be postulated as a viable option for addressing EDs in the context of PC in the Spanish NHS.
Ethics Statement
The study was approved by the ethics and research committee of the Hospital Universitario de la Plana (31_10_2022).
Consent
All participants consented to participate and signed the informed consent form.
Conflicts of Interest
The authors declare no conflicts of interest.
Acknowledgments
We would like to thank all the individuals and professionals who have participated in the realization of this study. This study was supported by the Plan Estatal de Investigación Científica, Técnica y de Innovación 2021‐2023, Proyectos de Generación de Conocimiento (PID2023‐151473OB‐100) and co‐funding by Gobierno de Aragón (Department of Science, University and Society knowledge) [Grant Number Research team S31_23R].
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
References
- Allen, L. B. , White K. S., Barlow D. H., Shear M. K., Gorman J. M., and Woods S. W.. 2010. “Cognitive‐Behavior Therapy (CBT) for Panic Disorder: Relationship of Anxiety and Depression Comorbidity With Treatment Outcome.” Journal of Psychopathology and Behavioral Assessment 32, no. 2: 185–192. 10.1007/s10862-009-9151-3. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Álvarez, M. , Atienza G., Avila M. J., González A., Guitián D., and De Las Heras E.. 2023. Guía de práctica clínica sobre el Manejo de la Depresión en el Adulto, 2nd ed. GuíaSalud. 10.46995/gpc_534. [DOI] [Google Scholar]
- American Psychiatric Association . 2013. Diagnostic and Statistical Manual of Mental Disorders, 5th Edition. American Psychiatric Association. 10.1176/appi.books.9780890425596. [DOI] [Google Scholar]
- Ayuso‐Bartol, A. , Gómez‐Martínez M. Á., Riesco‐Matías P., Yela‐Bernabé J. R., Crego A., and Buz J.. 2024. “Systematic Review and Meta‐Analysis of the Efficacy and Effectiveness of the Unified Protocol for Emotional Disorders in Group Format for Adults.” International Journal of Mental Health and Addiction ahead of print. 10.1007/s11469-024-01330-z. [DOI] [Google Scholar]
- Badia, X. , Roset M., Montserrat S., Herdman M., and Segura A.. 1999. “The Spanish Version of EuroQol: A Description and Its Applications. European Quality of Life Scale.” Medicina Clinica 112, no. S1: 79–85. [PubMed] [Google Scholar]
- Barlow, D. H. , Curreri A. J., and Woodard L. S.. 2021. “Neuroticism and Disorders of Emotion: A New Synthesis.” Current Directions in Psychological Science 30, no. 5: 410–417. 10.1177/09637214211030253. [DOI] [Google Scholar]
- Barlow, D. H. and Farchione, T. J. , ed. 2018. Applications of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. Oxford University Press. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Barlow, D. H. , Sauer‐Zavala S., Farchione T. J., et al. 2018. Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: Therapist Guide. Oxford University Press. [Google Scholar]
- Base de Datos Clínicos de Atención Primara [BDCAP] . 2022. Problemas de salud. Aparato y Sección. https://pestadistico.inteligenciadegestion.sanidad.gob.es/publicoSNS/C/base-de-datos-de-clinicos-de-atencion-primaria-bdcap/problemas-de-salud.
- Bell, M. L. , Whitehead A. L., and Julious S. A.. 2018. “Guidance for Using Pilot Studies to Inform the Design of Intervention Trials With Continuous Outcomes.” Clinical Epidemiology 10: 153–157. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Bentley, K. H. , Gallagher M. W., Carl J. R., and Barlow D. H.. 2014. “Development and Validation of the Overall Depression Severity and Impairment Scale.” Psychological Assessment 26, no. 3: 815–830. 10.1037/a0036216. [DOI] [PubMed] [Google Scholar]
- Borkovec, T. D. , Abel J. L., and Newman H.. 1995. “Effects of Psychotherapy on Comorbid Conditions in Generalized Anxiety Disorder.” Journal of Consulting and Clinical Psychology 63: 479–483. [DOI] [PubMed] [Google Scholar]
- Brooks, R. 1996. “EuroQol: The Current State of Play.” Health Policy 37, no. 1: 53–72. [DOI] [PubMed] [Google Scholar]
- Brown, T. A. , Antony M. M., and Barlow D. H.. 1995. “Diagnostic Comorbidity in Panic Disorder: Effect on Treatment Outcome and Course of Comorbid Diagnoses Following Treatment.” Journal of Consulting and Clinical Psychology 63: 408–418. [DOI] [PubMed] [Google Scholar]
- Brown, T. A. , and Barlow D. H.. 2014. Anxiety and Related Disorders Interview Schedule for DSM‐5 (ADIS‐5). Oxford. [Google Scholar]
- Bulbena‐Vilarrasa, A. , Casquero‐Ruiz R., De Santiago Hernando M. L., et al. 2018. Guía de Práctica Clínica para el Manejo de Pacientes con Trastornos de Ansiedad en Atención Primaria. GuíaSalud. https://portal.guiasalud.es/wp-content/uploads/2018/12/GPC_430_Ansiedad_Lain_Entr_compl.pdf. [Google Scholar]
- Bullis, J. R. , Boettcher H., Sauer‐Zavala S., Farchione T. J., and Barlow D. H.. 2019. “What Is an Emotional Disorder? A Transdiagnostic Mechanistic Definition With Implications for Assessment, Treatment, and Prevention.” Clinical Psychology: Science and Practice 26, no. 2: e12278. 10.1111/cpsp.12278. [DOI] [Google Scholar]
- Burguillos, A. I. 2022. “Características Sociodemográficas Y Síntomas Psicopatológicos De Pacientes Atendidos Por Psicología Clínica En Atención Primaria.” MLS Psychology Research 5, no. 2: 183–200. 10.33000/mlspr.v5i2.1143. [DOI] [Google Scholar]
- Cano‐Vindel, A. , Muñoz‐Navarro R., Moriana J. A., Ruiz‐Rodríguez P., Medrano L. A., and González‐Blanch C.. 2022. “Transdiagnostic Group Cognitive Behavioural Therapy for Emotional Disorders in Primary Care: The Results of the PsicAP Randomized Controlled Trial.” Psychological Medicine 52, no. 15: 3336–3348. 10.1017/S0033291720005498. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Carlucci, L. , Saggino A., and Balsamo M.. 2021. “On the Efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: A Systematic Review and Meta‐Analysis.” Clinical Psychology Review 87: 101999. 10.1016/j.cpr.2021.101999. [DOI] [PubMed] [Google Scholar]
- Cassiello‐Robbins, C. , Southward M. W., Tirpak J. W., and Sauer‐Zavala S.. 2020. “A Systematic Review of Unified Protocol Applications With Adult Populations: Facilitating Widespread Dissemination via Adaptability.” Clinical Psychology Review 78: 101852. 10.1016/j.cpr.2020.101852. [DOI] [PubMed] [Google Scholar]
- Cipriani, A. , Furukawa T. A., Salanti G., et al. 2018. “Comparative Efficacy and Acceptability of 21 Antidepressant Drugs for the Acute Treatment of Adults With Major Depressive Disorder: A Systematic Review and Network Meta‐Analysis.” Lancet 391, no. 10128: 1357–1366. 10.1016/S0140-6736(17)32802-7. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Consejo General de la Psicología de España . 2019. Propuesta para que haya psicólogos clínicos en Atención Primaria de todas las comunidades autónomas. https://www.infocop.es/viewarticle/?articleid=7987.
- Consejo General de la Psicología de España . 2023. Aumentan las consultas en AP por problemas de salud mental. Infocop. https://www.infocop.es/aumentan-las-consultas-en-ap-por-problemas-de-salud-mental/. [Google Scholar]
- Corpas, J. , Moriana J. A., Venceslá J. F., and Gálvez‐Lara M.. 2022. “Effectiveness of Brief Group Transdiagnostic Therapy for Emotional Disorders in Primary Care: A Randomized Controlled Trial Identifying Predictors of Outcome.” Psychotherapy Research 32, no. 4: 456–469. 10.1080/10503307.2021.1952331. [DOI] [PubMed] [Google Scholar]
- Derrett, S. , Black J., and Herbison G. P.. 2009. “Outcome After Injury—A Systematic Literature Search of Studies Using the Eq‐5D.” Journal of Trauma: Injury, Infection & Critical Care 67, no. 4: 883–890. [DOI] [PubMed] [Google Scholar]
- Echeburúa, E. , de Corral P., and Fernández‐Montalvo J.. 2000. “Escala de Inadaptación: Propiedades Psicométricas En Contextos Clínicos.” Análisis y Modificación de Conducta 26, no. 107: 325–340. [Google Scholar]
- Fairburn, C. G. , Cooper Z., and Shafran R.. 2003. “Cognitive Behaviour Therapy for Eating Disorders: A “Transdiagnostic” Theory and Treatment.” Behaviour Research and Therapy 41, no. 5: 509–528. 10.1016/S0005-7967(02)00088-8. [DOI] [PubMed] [Google Scholar]
- Geers, A. L. , Rose J. P., Fowler S. L., Rasinski H. M., Brown J. A., and Helfer S. G.. 2013. “Why Does Choice Enhance Treatment Effectiveness? Using Placebo Treatments to Demonstrate the Role of Personal Control.” Journal of Personality and Social Psychology 105, no. 4: 549–566. 10.1037/a0034005. [DOI] [PubMed] [Google Scholar]
- Gómez‐Esteban, R. 2022. “La medicalización del sufrimiento subjetivo.” Revista de la Asociación Española de Neuropsiquiatría 42, no. 142: 99–108. 10.4321/s0211-57352022000200006. [DOI] [Google Scholar]
- Gratz, K. L. , and Roemer L.. 2004. “Multidimensional Assessment of Emotion Regulation and Dysregulation: Development, Factor Structure, and Initial Validation of the Difficulties in Emotion Regulation Scale.” Journal of Psychopathology and Behavioral Assessment 26, no. 1: 41–54. [Google Scholar]
- Gøtzsche, P. C. 2016. Psicofármacos que matan y denegación organizada (1a ed). Los Libros del Lince.
- Hervás, G. , and Jódar R.. 2008. “Adaptación al castellano de la Escala de Dificultades en la Regulación Emocional.” Clínica y salud 19, no. 2: 139–156. [Google Scholar]
- IBM Corp . 2017. IBM SPSS Statistics for Windows, Version 25.0. IBM Corp. [Google Scholar]
- IQVIA . 2022. La salud mental: El reto invisible. https://www.iqvia.com/-/media/iqvia/pdfs/spain/brochure/iqvia_saludmental_elretoinvisible.pdf.
- Larsen, D. L. , Attkisson C. C., Hargreaves W. A., and Nguyen T. D.. 1979. “Assessment of Client/Patient Satisfaction: Development of a General Scale.” Evaluation and Program Planning 2, no. 3: 197–207. [DOI] [PubMed] [Google Scholar]
- Leichsenring, F. , Steinert C., Rabung S., and Ioannidis J. P. A.. 2022. “The Efficacy of Psychotherapies and Pharmacotherapies for Mental Disorders in Adults: An Umbrella Review and Meta‐Analytic Evaluation of Recent Meta‐Analyses.” World Psychiatry: Official Journal of the World Psychiatric Association (WPA) 21, no. 1: 133–145. 10.1002/wps.20941. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Longley, S. L. , and Gleiser T. S.. 2023. “Efficacy of the Unified Protocol: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials.” Clinical Psychology: Science and Practice 30, no. 2: 208–221. 10.1037/cps0000141. [DOI] [Google Scholar]
- McHugh, R. K. , and Barlow D. H.. 2010. “The Dissemination and Implementation of Evidence‐Based Psychological Treatments: A Review of Current Efforts.” American Psychologist 65, no. 2: 73–84. 10.1037/a0018121. [DOI] [PubMed] [Google Scholar]
- Ministerio de Sanidad . 2022. Informe Anual del Sistema Nacional de Salud 2020‐2021 [Informes, estudios e investigación]. Ministerio de Sanidad, centro de publicaciones. [Google Scholar]
- Ministerio de Sanidad . 2023. Informe Anual del Sistema Nacional de Salud 2022. Resumen Ejecutivo. https://www.sanidad.gob.es/estadEstudios/estadisticas/sisInfSanSNS/tablasEstadisticas/InfAnualSNS2022/Inf_anual_2022_Res_Ejecutivo.pdf.
- National Institute for Health and Care Excellence [NICE] . 2022. Depression in Adults: Tratment and Management. https://www.nice.org.uk/guidance/ng222/resources/depression-in-adults-treatment-and-management-pdf-66143832307909. [PubMed]
- Norcross, J. C. , and Wampold B. E.. 2019. “Personalizing Psychotherapy: Results, Conclusions, and Practices.” In Psychotherapy Relationships That Work, edited by Norcross En. J. C. and Wampold B. E., 329–342. Oxford University Press. 10.1093/med-psych/9780190843960.003.0011. [DOI] [Google Scholar]
- Norman, S. B. , Hami Cissell S., Means‐Christensen A. J., and Stein M. B.. 2006. “Development and Validation of an Overall Anxiety Severity and Impairment Scale (OASIS).” Depression and Anxiety 23, no. 4: 245–249. 10.1002/da.20182. [DOI] [PubMed] [Google Scholar]
- Norton, P. J. 2012. Group Cognitive‐Behavioral Therapy of Anxiety: A Transdiagnostic Treatment Manual. Guilford Press. [Google Scholar]
- Osma, J. , Martínez‐Loredo V., Quilez‐Orden A., et al. 2023. “Multidimensional Emotional Disorders Inventory: Reliability and Validity in a Spanish Clinical Sample.” Journal of Affective Disorders 320: 65–73. 10.1016/j.jad.2022.09.140. [DOI] [PubMed] [Google Scholar]
- Osma, J. , Quilez‐Orden A., Ordóñez J., Peris‐Baquero Ó., and Echeburúa E.. 2024. “Psychometric Properties of the Maladjustment Inventory in a Spanish Clinical and Student Sample.” BMC Psychology 12: 666. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Osma, J. , Quilez‐Orden A., Suso‐Ribera C., et al. 2019. “Psychometric Properties and Validation of the Spanish Versions of the Overall Anxiety and Depression Severity and Impairment Scales.” Journal of Affective Disorders 252: 9–18. 10.1016/j.jad.2019.03.063. [DOI] [PubMed] [Google Scholar]
- De Paul, N. F. , and Caver K. A.. 2021. “A Pilot Study of a Brief Group Adaptation of the Unified Protocol In Integrated Primary Care.” Psychological Services 18, no. 3: 416–425. 10.1037/ser0000406. [DOI] [PubMed] [Google Scholar]
- Peris‐Baquero, Ó. , Moreno J. D., and Osma J.. 2023. “Long‐Term Cost‐Effectiveness of Group Unified Protocol in the Spanish Public Mental Health System.” Current Psychology 42, no. 26: 22462–22477. 10.1007/s12144-022-03365-8. [DOI] [Google Scholar]
- Rosellini, A. J. , and Brown T. A.. 2014. “Initial Interpretation and Evaluation of a Profile‐Based Classification System for the Anxiety and Mood Disorders: Incremental Validity Compared to DSM‐IV Categories.” Psychological Assessment 26, no. 4: 1212–1224. 10.1037/pas0000023. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Rosellini, A. J. , and Brown T. A.. 2019. “The Multidimensional Emotional Disorder Inventory (MEDI): Assessing Transdiagnostic Dimensions to Validate a Profile Approach to Emotional Disorder Classification.” Psychological Assessment 31, no. 1: 59–72. 10.1037/pas0000649. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Sakiris, N. , and Berle D.. 2019. “A Systematic Review and Meta‐Analysis of the Unified Protocol as a Transdiagnostic Emotion Regulation Based Intervention.” Clinical Psychology Review 72: 101751. 10.1016/j.cpr.2019.101751. [DOI] [PubMed] [Google Scholar]
- Sánchez‐Reales, S. , Tornero‐Gómez M. J., Martín‐Oviedo P., Redondo‐Jiménez M., and del‐Arco‐Jódar R.. 2015. “Psicología Clínica en Atención Primaria: Descripción de un año de asistencia.” SEMERGEN ‐ Medicina de Familia 41, no. 5: 254–260. 10.1016/j.semerg.2014.06.001. [DOI] [PubMed] [Google Scholar]
- Sauer‐Zavala, S. , Gutner C. A., Farchione T. J., Boettcher H. T., Bullis J. R., and Barlow D. H.. 2017. “Current Definitions of “Transdiagnostic” in Treatment Development: A Search for Consensus.” Behavior Therapy 48, no. 1: 128–138. 10.1016/j.beth.2016.09.004. [DOI] [PubMed] [Google Scholar]
- Schaeuffele, C. , Meine L. E., Schulz A., et al. 2024. “A Systematic Review and Meta‐Analysis of Transdiagnostic Cognitive Behavioural Therapies for Emotional Disorders.” Nature Human Behaviour 8: 493–509. 10.1038/s41562-023-01787-3. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Silverman, A. L. , and Teachman B. A.. 2022. “The Relationship Between Access to Mental Health Resources and Use of Preferred Effective Mental Health Treatment.” Journal of Clinical Psychology 78, no. 6: 1020–1045. 10.1002/jclp.23301. [DOI] [PubMed] [Google Scholar]
- Smith, A. H. , Norton P. J., and McLean C. P.. 2013. “Client Perceptions of Therapy Component Helpfulness in Group Cognitive‐Behavioral Therapy for Anxiety Disorders.” Journal of Clinical Psychology 69, no. 3: 229–239. 10.1002/jclp.21926. [DOI] [PubMed] [Google Scholar]
- Trejo‐Rosales, A. 2022. Frecuencia de Sospechas de Reacciones Adversas de Medicamentos (SRAM) con psicofármacos en pacientes con polifarmacia. Universidad Autónoma Metropolitana. https://repositorio.xoc.uam.mx/jspui/bitstream/123456789/26443/1/250096.pdf. [Google Scholar]
- Watts, S. E. , Turnell A., Kladnitski N., Newby J. M., and Andrews G.. 2015. “Treatment‐as‐Usual (Tau) Is Anything but Usual: A Meta‐Analysis of CBT Versus TAU for Anxiety and Depression.” Journal of Affective Disorders 175: 152–167. 10.1016/j.jad.2014.12.025. [DOI] [PubMed] [Google Scholar]
- Wilamowska, Z. A. , Thompson‐Hollands J., Fairholme C. P., Ellard K. K., Farchione T. J., and Barlow D. H.. 2010. “Conceptual Background, Development, and Preliminary Data From the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders.” Depression and Anxiety 27, no. 10: 882–890. 10.1002/da.20735. [DOI] [PubMed] [Google Scholar]
- World Health Organisation . 2023. Mental Health Gap Action Programme (mhGAP) Guideline for Mental, Neurological and Substance Use Disorders. https://www.infocop.es/wp-content/uploads/2024/01/Mental-Health-Gap-Action.pdf. [PubMed]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Citations
- Base de Datos Clínicos de Atención Primara [BDCAP] . 2022. Problemas de salud. Aparato y Sección. https://pestadistico.inteligenciadegestion.sanidad.gob.es/publicoSNS/C/base-de-datos-de-clinicos-de-atencion-primaria-bdcap/problemas-de-salud.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
