Participant acceptability and clinician satisfaction of cognitive behavioural therapy and medication management algorithm compared with enhanced standard care for treatment of depression among youth with HIV

Abstract

Background:

Primary results of the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) 2002 trial showed that cognitive behavioural therapy (CBT) and medication management algorithm (MMA) (COMB-R) significantly improved depression in youth with HIV (YWH) compared with enhanced standard care (ESC). Acceptability and satisfaction were examined among study participants and clinicians.

Method:

Between March 2017 and March 2019, 13 U.S. sites enrolled YWH, aged 12–24, diagnosed with nonpsychotic depression. Sites were randomised to either COMB-R (CBT by a therapist and licensed prescriber) or ESC (standard psychotherapy and medication management). After the intervention (week 24), participants, prescribers, and therapists rated acceptability and satisfaction. We compared site-level means using Wilcoxon tests.

Results:

Both COMB-R (n = 69) and ESC (n = 71) participants had a mean age of 21.4 years, with 53% female, and 54% having acquired HIV perinatally. Baseline age, sex, depression levels, RNA viral load, and CD4 count were comparable between arms. The distribution of site-level mean participant acceptability was greater in COMB-R compared with ESC (p = 0.04). The distribution of site-level mean prescriber satisfaction was greater in COMB-R (p = 0.01). There was no evidence that the site-level mean therapist satisfaction did not differ between arms (p = 0.52).

Discussion:

Acceptability and satisfaction for participants and licensed prescribers were higher at COMB-R sites compared with standard of care, indicating that this tailored, manual-guided, collaborative, measured care intervention was less burdensome in terms of the number of visits. Patient and medication provider satisfaction rates were higher than standard of care.

Conclusion:

While these results support the use of CBT and MMA in treating depression among YWH, further research is required to determine generalisability.

Background

Globally, depressive symptoms have increased among adolescents in the last decade, with an estimated 34% of adolescents aged 10–19 at risk for clinical depression (Shorey et al., 2022). Depression is a primary cause of disability in youth in the United States, leading to challenges in school, work, peer, and familial relationships, impacting chronic lifelong depression and the incidence of suicidal ideation, attempts, and completion (Mangione et al., 2022). Globally, the prevalence rate of adult people with HIV/AIDS (PWH) living with depression is 31% (Rezaei et al., 2019). In youth with HIV/AIDS (YWH), the estimated global rate of depression is 37% (Ayano et al., 2021), with 14% of YWH experiencing suicidal ideation (Tsegay & Ayano, 2020). With nearly 2.0 million YWH aged 10–19 globally and upwards of 183 000 annual new infections in youth by 2030 (UNICEF, 2022), the convergence of the mental health crisis and HIV epidemic in youth needs attention.

Adolescents with chronic illness face challenges with engagement in care, adherence to therapy, and attaining milestones that support individuation and transition to adulthood (Barr et al., 2022).YWH have the additional challenges of stigma, disclosure, and the conflation of sexuality as part of their disease, which complicate adolescent life with an HIV diagnosis (Tassiopoulos et al., 2020). These qualities are likely related to the higher rates of depression in YWH than those without HIV (Ayano et al., 2021; Willis et al., 2018). It is important to find therapeutic modalities that are effective in YWH and have good acceptability and feasibility by those providing the treatment.

Selective serotonin reuptake inhibitors (SSRIs) have been described as a safe and effective treatment for depression in adult PWH, including improving health outcomes such as adherence to antiretroviral therapy and increased CD4 cell count (Eshun-Wilson et al., 2018). In turn, increased treatment adherence leads to viral suppression and lower public health risks of further HIV infection in the community (Gandhi et al., 2023). Practice guidelines, particularly for PWH, recommend that combining medication management with evidence-based psychotherapies, such as cognitive behavioural therapy (CBT), results in a more rapid reduction of depressive symptoms compared to utilising a single treatment modality, whether it be psychotropic medication or psychotherapy alone (American Psychiatric Association [APA] 2019; Cheung et al., 2018; Richardson et al., 2014). Most of the research on satisfaction with antidepressant therapy has been completed in adults and shows greater satisfaction with antidepressant use among those who presented with milder depressive symptoms, received longer-term treatment, and viewed medication therapy in a favourable way (López-Torres Hidalgo et al., 2016). Other studies focus on the relationship between satisfaction with medication management and adverse effects, where greater satisfaction is associated with fewer adverse effects (Hughes et al., 2017).

Choque Olssen and colleagues’ (2021) systematic review and meta-analysis of treatment satisfaction using CBT in children and youth with anxiety and depression demonstrated moderate to high treatment satisfaction. While CBT has been studied extensively and is an effective non-pharmacologic intervention to reduce depression in adult PWH (Kennard et al., 2014; Safren et al., 2016; Shi et al., 2019), and youth-friendly CBT-based interventions are both feasible and acceptable to the patients., an assessment of provider acceptability is missing from the research on CBT among YWH.

The existing literature on treatment satisfaction in mental healthcare often focuses on the perspectives of patients and parents, with less attention given to the therapist’s perspective. Studies that include the therapist’s perspective are relatively rare (Walsh et al., 2019). This oversight is important because therapist satisfaction and acceptance of the treatment process may directly impact the quality of mental healthcare (Viefhaus et al., 2019). Furthermore, examining the therapist’s perspective may provide valuable feedback, enhancing the quality of mental healthcare. For example, Viefhaus and colleagues 2021) found that greater reductions in patients’ symptoms, based on the Child Behavior Checklist (Achenbach et al., 1999) were associated with greater satisfaction with the CBT treatment by the therapists. Additionally, the cooperation of the patient and the parent during therapy, as rated by the therapist at the end of therapy, was associated with better therapist satisfaction ratings (Viefhaus et al., 2019). Nonetheless, further research is needed to directly compare therapist satisfaction and acceptance of brief, focused therapeutic interventions. Therefore, the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) 2002 team collected data on the feasibility and acceptability of their study of managing depression in YWH.

The primary results of the IMPAACT 2002 trial showed that CBT and medication management algorithm (MMA) (COMB-R) significantly improved depression outcomes in YWH at sites across the United States compared with enhanced standard care (ESC) (Brown et al., 2022; Brown et al., 2021). At week 24, YWH at COMB-R sites, compared with ESC sites, reported significantly fewer depressive symptoms on the Quick Inventory for Depression Symptomatology Self-Report (QIDS-SR:) (Rush et al., 2003; Bernstein et al., 2010) where each item is scored on a scale from 0 to 3 points, with a total score ranging from 0 to 27. The site-level mean QIDS-SR score in this study was 6.7 vs. 10.6, p = 0.01. Specifically, a greater mean proportion showed a treatment response (62.3% vs. 17.9%, p < 0.001), and a greater mean proportion were in remission (47.9% vs. 17.0%, p = 0.01). There was no evidence of a significant difference between the site-level mean HIV viral load or CD4 T-cell levels between arms at week 24 (Brown et al., 2021).

In summary, YWH who received 24 weeks of a combination of health and wellness CBT and medication management reported significantly fewer depressive symptoms on the QIDS-SR compared to those who received standard care. The aim of this secondary analysis was to compare the acceptability and satisfaction of COMB-R and ESC. At the conclusion of the intervention (week 24), we assessed feasibility and acceptability among study participants and clinicians at COMB-R and ESC sites based on their ratings from multi-question surveys. Site clinicians were classified as either prescribers or therapists based on their clinician function at the site. Prescribers were healthcare providers licensed to prescribe anti-depressants in this patient population (i.e., physicians and advanced practice providers). Therapists were licensed mental health professionals trained to use psychotherapeutic techniques to treat youth.

Methodology

Trial design and participants

The IMPAACT 2002 study was a prospective, multi-site, two-arm, cluster (site) randomised study of the efficacy of CBT and MMA (COMB-R) for depression in YWH compared with ESC (ClinicalTrials.gov Identifier: NCT02939131). The intervention was evaluated over a 24-week period and compared to ESC provided at HIV clinics. ESC encompasses routine psychotherapy, such as CBT, and medication management, including SSRIs, provided at HIV clinics, supplemented by a 2-hour training session for site clinicians. COMB-R was a CBT and MMA tailored for YWH. The approximately 14-session CBT was flexible in its use of motivational engagement, psychoeducation, core CBT skills training (e.g., cognitive restructuring and addressing beliefs), and relapse prevention. Activities were selected in response to the patient’s current stressors (e.g., stigma and chronic illness) and goals. The MMA framework, tailored for YWH, facilitates clinical decision-making based on the evidence of available treatments and regular measurement of patient’s depression symptoms. The MMA provides flexible guidelines for providers, including not using medication. The MMA includes decision points throughout treatment to evaluate whether depression is improving using symptom measurements and provides alternative strategies if there is inadequate clinical improvement.

COMB-R therapists received a comprehensive 4-hour group videoconference training. This training included a review of the CBT manual and skills training. Additionally, videotaped illustrative sessions were viewed and discussed, along with clinical vignettes to provide practical insights. Medication prescribers participated in a 2-hour group video training session. This training covered instructions and a review of the MMA, as well as strategies for integrating depression symptom assessments into medication management decisions.

To further support the implementation, COMB-R therapists and medication prescribers had access to monthly group supervision calls where they could discuss cases with members of the core clinical trial team. Although attendance at these calls was not mandatory, it provided an additional layer of support. The initial online trainings were recorded, and all training materials and videos were preserved to train new staff and for refresher purposes, as needed. The ESC site clinicians also received training, albeit more limited. They participated in a 2-hour training session on current principles for the use of medication and psychotherapy for depression. This training was developed by experts and was available as a refresher, but it did not provide details on the MMA or the CBT used in the COMB-R treatment. Overall, the training protocols were meticulously designed to prepare site staff for their roles in the study, ensuring a standardised approach across different sites.

Participants were YWH (aged 12–24 years) in the United States diagnosed with moderate to severe depression, defined as a Quick Inventory of Depressive Symptomatology Clinician Rated (QIDS-C) score ≥11 (Rush et al., 2003). The treatment sites were part of the IMPAACT Network and included a variety of healthcare settings, such as academic centres, community mental health centres, primary care offices, and clinics specifically dedicated to HIV care. The study encompassed a broad geographic distribution across the United States, ensuring representation from diverse regions and both urban and rural settings. Specifically, the sites included prominent academic institutions and specialised hospitals such as David Geffen School of Medicine at University of California Los Angeles, St. Jude Children’s Research Hospital, University of Colorado School of Medicine, Baylor College of Medicine, Stony Brook Children’s Hospital, South Florida Children’s Diagnostic and Treatment Center in Fort Lauderdale, Emory University School of Medicine, University of Southern California Los Angeles, Rush University Cook County Hospital Chicago, University of California San Diego, and Johns Hopkins University School of Medicine. The study also included community-based healthcare providers such as the Bronx Care Health System and Jacobi Medical Center in New York. This diverse selection of sites was intended to ensure a comprehensive representation of the population of YWH across the United States, capturing a wide range of demographic and socio-economic backgrounds, thereby enhancing the generalisability of the study findings to the broader YWH population in the United States.

Using restricted randomisation to balance site characteristics, 14 U.S. IMPAACT sites were randomly assigned to the COMB-R or ESC arm (see Brown et al., 2021). Sites obtained Institutional Review Board approval and followed all ethical guidelines consistent with the Declaration of Helsinki in conducting this research. Participants and caregiver(s) gave informed assent and consent before data collection.

Acceptability and satisfaction surveys

After the intervention’s conclusion at week 24, acceptability and satisfaction surveys were collected from participants, licensed prescribers (providers), and therapists (Supplemental Table 1). The participant acceptability survey was adapted from the Client Satisfaction Questionnaire-8 (Attkinson & Zqick, 1982). The acceptability survey included eight questions scored on a Likert scale ranging from 1 to 4, with higher scores representing higher acceptability. The Likert scales used straightforward language, thereby ensuring face validity (Boateng et al., 2018). However, these scales were not validated against other established measures. The scales for therapists and medical providers differed in their focus and structure. Therapists were asked to rate the intervention based on the presence and extent of specific characteristics, such as “flexibility.” These items were typically rated on a 4-point scale, which is a common approach for quantifying the degree of a characteristic (Boateng et al., 2018). In contrast, medical providers were asked to rate their agreement with specific statements, such as “MMA is difficult to use.” These items were rated on a 5-point scale, which included a neutral option, allowing respondents to indicate “neither agree nor disagree” or “neutral”. This design aimed to capture a broader range of responses and provide a more nuanced understanding of the providers’ perspectives on the intervention.

The licensed prescriber satisfaction survey included two questions about the usefulness and impact of the MMA for COMB-R sites specifically. Prescribers in both arms completed two questions about participant improvement and the quality of the treatment. Responses were scored on a Likert scale ranging from 0 to 4, with higher scores representing higher satisfaction. The therapist satisfaction survey included six questions about perceived appropriateness, flexibility, and how well the treatment fit with their clinic. Items were scored on a Likert scale ranging from 0 to 3, with higher scores representing higher satisfaction.

Statistical analysis

All analyses were conducted using the intent-to-treat principle (i.e., analysed by randomisation assignment) with SAS software v9.4 (SAS Institute, Cary, NC). Per the prespecified statistical analysis plan, missing data were handled using a complete case approach, which excluded participants who did not have week 24 survey responses. Because sites were randomised instead of participants, methods for cluster-randomised studies were implemented (Hayes & Moulton, 2009). For baseline variables, the site-specific (i.e., cluster-specific) summary scores (for continuous variables, the mean within a site; for dichotomous variables, the percentage within a site) were computed. The site-specific summary scores’ median, 25th percentile (Q1), 75th percentile (Q3), mean, and standard deviation are presented. For acceptability and satisfaction scores, we first computed the mean Likert score across all questions for each survey by the participant. Thereafter, we calculated the site-specific mean summary score for each survey. These mean site-specific summary scores were summarised using the median, minimum (min), and maximum (max) and compared between arms using Wilcoxon tests. Participant and clinician responses by site were also summarised for each survey using bar charts.

Results

Six COMB-R sites enrolled 81 participants (69 included in the analysis), seven ESC sites enrolled 75 participants (71 included), and one COMB-R site dropped out after randomisation. Reasons for exclusion included dropping out before the week 24 window (n = 9), missing the week 24 appointment (n = 6), and no data collected at the week 24 appointment (n = 1). In the COMB-R arm, the median site-level mean age was 21.7 years, the median site-level percentage of males was 41%, and the median site-level percentage of participants who acquired HIV perinatally was 40% (Table 1). In the ESC arm, the median site-level mean age was 21.2 years, the median site-level percentage of males was 50%, and the median site-level percentage of participants who acquired HIV perinatally was 60% (Table 1).

Table 1:

Site-level summary of baseline characteristics

Characteristics	COMB-R (N = 6 sites)		ESC (N = 7 sites)		p
	Median (Q1, Q3)	Mean (SD)	Median (Q1, Q3)	Mean (SD)	Wilcoxon rank sum test
% Male at birth	41.4 (25.0, 81.8)	46.8 (29.7)	50.0 (31.3, 60.0)	44.1 (23.3)	0.94
Mean age (years) at entry	21.7 (20.9, 21.9)	21.6 (0.5)	21.2 (20.6, 22.8)	21.3 (1.8)	0.78
% Black	89.9 (27.3, 91.7)	66.5 (42.0)	60.0 (37.5, 80.0)	57.5 (32.6)	0.47
% with perinatal transmission	39.6 (36.4, 75.0)	48.7 (24.3)	60.0 (33.3, 73.3)	55.7 (22.3)	0.67
Mean QIDS-C1 depression level	17.3 (14.9, 18.0)	16.6 (1.7)	14.3 (13.9, 16.7)	15.2 (2.0)	0.20
Mean QIDS-SR1 depression level	16.5 (15.0, 17.1)	15.9 (1.6)	14.0 (12.3, 15.6)	14.6 (3.3)	0.15
Mean log10 HIV-1 RNA viral load (copies/mL)	1.9 (1.8, 2.6)	2.2 (0.7)	2.1 (1.9, 2.4)	2.1 (0.3)	0.89
Mean CD4 count (cells/mm3)	741.8 (584.3, 778.5)	678.1 (161.5)	831.2 (505.7, 842.0)	704.0 (193.6)	0.39

Note. For analysis of dichotomous variables, entries are median (Q1, Q3) of site-specific percentages. 1QIDS-C and QIDS-SR are scored from 0 to 27, with a higher score indicating greater symptom severity: 0–5 not depressed, 6–10 mild, 11–15 moderate, 16–20 severe, and 21+ very severe.

The median (min, max) site-level mean participant acceptability score was 3.7 (3.5, 3.9) in the COMB-R arm and 3.4 (3.3, 3.7) in the ESC arm (Table 2; Figure 1). The distribution of site-level mean participant acceptability (e.g., quality, expectations, and overall satisfaction with treatment) was significantly greater at COMB-R sites compared with ESC sites (p = 0.04). Therefore, it is more likely that a randomly selected COMB-R site would have higher mean participant acceptability than a randomly selected ESC site.

Table 2:

Site-level summary of acceptability and satisfaction surveys

Survey	COMB-R (N = 6 sites)	ESC (N = 7 sites)	p
	Median (min, max)	Median (min, max)	Wilcoxon test
Mean participant acceptability (eight questions); scale from 1 to 4	3.7 (3.5, 3.9)	3.4 (3.3, 3.7)	0.04
Mean licensed prescriber satisfaction (two questions); scale from 0 to 4	3.2 (2.5, 3.4)	2.4 (2.0, 3.0)	0.01
Mean therapist satisfaction (six questions); scale from 0 to 3	2.1 (1.9, 2.8)	2.3 (2.0, 2.6)	0.52

Figure 1: Participant Acceptability Survey responses by site.

Note. COMB-R sites are represented by blue bars, and ESC sites are represented by purple bars. Likert Scale from 1 to 4, with higher scores representing higher acceptability.

The median (Q1, Q3) number of licensed prescribers was 2 (1.25, 2) in the COMB-R arm and 1 (1, 2.5) in the ESC arm; two COMB-R and three ESC sites had only one licensed prescriber. The median (min, max) site-level mean licensed prescriber satisfaction score based on the items assessed in both arms was 3.2 (2.5, 3.4) in the COMB-R arm and 2.4 (2.0, 3.0) in the ESC arm on a Likert Scale from 0 to 4, with 4 being the most desirable outcome (Table 2; Figure 2). The distribution of site-level mean licensed prescriber satisfaction (e.g., ease of using the intervention and improvement of participants) was greater in COMB-R compared with ESC (p = 0.01). Therefore, it is more likely that a randomly selected COMB-R site would have higher mean licensed prescriber satisfaction than a randomly selected ESC site.

Figure 2: Licensed Prescriber Satisfaction Survey responses by site.

Note. COMB-R sites are represented by blue bars, and ESC sites are represented by purple bars. Likert Scale from 0 to 4, with higher scores representing higher satisfaction.

The median (Q1, Q3) number of therapists was 1.5 (1, 2) in the COMB-R arm and 1 (1, 1.5) in the ESC arm; three COMB-R and five ESC sites had only one therapist. The median (min, max) site-level mean therapist satisfaction score was 2.1 (1.9, 2.8) in the COMB-R arm and 2.3 (2.0, 2.6) in the ESC arm (Table 2; Figure 3). The distribution of site-level mean therapist satisfaction (e.g., appropriateness, effectiveness, and flexibility) did not differ between arms (p = 0.52).

Figure 3: Therapist Satisfaction Survey responses by site.

Note. COMB-R sites are represented by blue bars, and ESC sites are represented by purple bars. Likert Scale from 0 to 3, with higher scores representing higher satisfaction.

Discussion

This multi-site, two-arm, cluster-randomised trial tested a measured-care combined treatment strategy that included an MMA and manualised CBT. A secondary aim was to explore the differences in acceptability and satisfaction of the interventions between. Overall, site-level participant satisfaction was high (greater than 3 on a 4-point scale) but significantly higher in the COMB-R arm compared with the ESC arm. While there were no data available to explain this difference several aspects of the combined CBT and MMA could be contributing factors. The Motivational Interviewing (MI) approach may have improved patient engagement and the focus on shared goals (Flynn, 2011; Nasstasia et al., 2019). CBT sessions were tailored to address current topics identified by patients, teaching core principles in a highly responsive manner using supplemental materials (Brown et al., 2021; Kennard et al., 2014). Patients were not required to start medications immediately, allowing prescribers to assess patients without the pressure of starting medications rapidly or automatically. This approach may have led to quicker symptom resolution compared to standard care and possibly faster than their previous treatments for depression, especially since most patients had moderate to severe depression and many had prior treatment experiences.

Licensed prescriber satisfaction was also significantly higher in the COMB-R arm compared with the ESC arm. Still, there was no evidence of a difference in site-level therapist satisfaction between the arms. This tailored, manual-guided, collaborative, measured care intervention was not only less burdensome in terms of the number of visits, but patient and medication provider satisfaction rates were higher than in the standard care intervention. This finding may be explained by supervision calls conducted during the study revealing that MMA providers valued several elements: having depression scores and their trajectories to guide treatment, specified time points to consider patient progress, and a structured approach to decision-making that still allowed for clinical judgement and patient preference. Thus, providers used a collaborative approach supported by a shared decision- making process, which often leads to higher patient satisfaction, since patients feel more engaged and respected in their treatment decisions (Maples et al., 2022).

Collaboration with therapists to better understand patient history and dynamics was also appreciated. Many therapists had extensive experience with YWH and were initially reluctant to use a manual, fearing it would limit their techniques, reduce flexibility, and be burdensome. The fact that there was no significant difference in satisfaction between the combined treatment and standard care arms could be considered a positive outcome. Future research should go beyond limited scales to better assess these factors using interviews and more detailed assessments.

With few studies examining CBT-based interventions in YWH (Choque Olsson et al., 2021), our findings showed that a combined strategy employing CBT tailored for YWH and MMA not only succeeded at lowering depressive symptoms but was deemed acceptable by participants and prescribing providers and not less acceptable than ESC for the site therapists. While our findings are limited to high-resource settings, there are encouraging data on CBT-based mental health and adherence interventions in lower-resource settings, including the possibility of training lay-healthcare workers on these types of interventions (Akena et al., 2016), thereby leading to a potential global impact on depression and YWH. This could provide valuable insight into factors influencing therapist satisfaction and potentially lead to improvements in the quality of mental healthcare for young PWH.

While some research suggests a link between therapist satisfaction and patient outcomes, more research is needed to understand this relationship fully (Markowitz, 2022). This study is part of a growing body of work highlighting the usefulness and acceptability of CBT in young people with anxiety and depression. Choque Olsson and colleagues (2021) reviewed 35 studies examining participant acceptance and feasibility in youth treated for depression and anxiety, suggesting moderate to high satisfaction with CBT. Notably, few studies included participant acceptability and feasibility as their primary objectives, and very few explored provider acceptability. In most cases, the efficacy of CBT was primary, and whether the treatment was acceptable to the young participants was secondary. However, finding an evidence-based strategy to treat young people acceptable to patients, medication providers, and therapists is critical, considering the rate at which mental health challenges continue to rise. The COVID-19 pandemic increased adolescents’ stress with school closures, disruption of routines, social isolation, job loss, and concerns about family illness (Mayne et al., 2021).

Furthermore, suicide, which is the second leading cause of death in the United States in 12- to 24-year-olds, increased by 52.2% between 2001 and 2021 (Curtin & Garnett, 2023). This increase highlights the need for more research on implementing mental health treatment programmes to not only treat YWH, but also the adolescent and young adult population. The use of implementation science to examine acceptable and feasible strategies in our evidence-based interventions in real-world settings is paramount.

A tailored CBT and MMA approach is particularly useful for YWH for several reasons:

1. Targeted Depression and Adherence Strategies: The intervention can be tailored towards treatment designed to reduce depression, improve adherence to medical regimens, and promote overall mental health among YWH. This approach aims to decrease negative mood and cognitions while enhancing strengths and positive experiences.

2. Integration of MI: The inclusion of MI strategies helps to engage individuals in treatment and fosters adherence to medical regimens. This is crucial for YWH, who often face challenges such as stigma, medical symptoms, and the transition from paediatric to adult care.

3. Addressing Psychosocial Stressors: The tailored CBT approach specifically addresses the psychosocial stresses associated with HIV infection, such as poverty, stigma, and alienation from families. This is achieved through stages of treatment that include psychoeducation, motivation for treatment, reducing depressive symptoms, and achieving and maintaining wellness.

4. Feasibility and Acceptability: The combined CBT and MMA intervention has been shown to be feasible and acceptable when delivered by existing staff in HIV medical care clinics. This suggests that the intervention could be successfully integrated into routine care without increasing the burden on patients by requiring additional clinic visits.

5. Improved Outcomes: Studies demonstrated that this combined approach significantly improves depression outcomes in YWH compared to ESC. The structured yet flexible nature of the intervention allows for clinical judgement and patient preference, which is highly valued by both therapists and medical providers (Brown et al., 2022; Brown et al., 2021).

Limitations and future recommendations

Survey data variability was limited by the study design because sites where multiple participants received care from the same clinician (i.e., licensed prescriber or therapist), meant that clinicians completed surveys for multiple participants within the same site. Therefore, sites with only one clinician were likely to have less variability in scores than sites with multiple clinicians. Even though the team made every attempt to standardise the treatment, individuals still had their own styles and ways of connecting and communicating, which may impact scores and influence variability and generalisability to other similar treatment programmes.

Because only about half of the participants were prescribed medication, the data about effectiveness and satisfaction with medication treatment were from a more limited sample, which may impact findings. We did not use a validated or standardised measure to assess feasibility and acceptability in the medication prescribers, which is common in this type of research and had been noted as a limitation across other studies (Choque Olsson et al., 2021). Therefore, developing validated instruments to assess feasibility and acceptability for medication providers is critical. Another limitation of this study is that the ESC clinicians did not receive ongoing supervision. While the ESC site clinicians participated in a 2-hour training session on current principles for the use of medication and psychotherapy for depression, this training did not include details on the MMA or the CBT used in the COMB-R treatment, nor did it provide ongoing supervision.

Additionally, missing data were handled using a complete case approach, which assumes that data were missing completely at random. Consequently, participant acceptability scores do not include participants who discontinued the study before or missed the week 24 visit. Finally, the study was not specifically powered for these secondary analyses, and there were no adjustments for multiple testing (the week 24 QIDS-SR score analysis was the prespecified primary analysis).

Conclusion

The combined treatment approach using CBT tailored for YWH and MMA effectively reduced depressive symptoms. Furthermore, findings suggest that the COMB-R treatment was more acceptable to participants and prescribing providers than ESC. Site-level therapist satisfaction was comparable between the COMB-R arm and the ESC arm, indicating that using a tailored approach was no less acceptable to therapists than ESC, supporting the development of treatment options designed for specific patient populations. Gaining a deeper understanding of the acceptability and usefulness of treatment methods for both patients and providers alike would support implementing evidence-based interventions, such as measured care, MMA, and CBT, in clinics and community settings to treat adolescents and young adults with depression to improve YWH’s health and well-being. Because COMB-R was not only an effective strategy but also had a high level of satisfaction, our findings support the use of similar interventions in YWH and other chronic conditions. While there are studies on satisfaction and acceptance in mental health interventions, further research is needed to fully understand the factors that influence patient and therapist acceptability to enhance the quality and efficacy of therapeutic interventions in youth experiencing depression.