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. 2020 Jul 20;2020(7):CD013684. doi: 10.1002/14651858.CD013684

Recabarren 2019.

Study characteristics
Methods Study design: RCT
Study grouping: parallel group
Unit of randomisation: individuals
Power (power & sample size calculation, level of power achieved): To determine the optimal sample size, the trialists performed an a priori power analysis using G∗Power and computed an expected medium effect size based on the meta‐analysis of Regehr 2013 for an ANOVA (analysis of variance) with 2 measurement points, 2 groups and between and within factors interaction; sample size of 54 obtained; in addition, drop‐out rate of 15% estimated based on the results of similar intervention programme, leading to an adequate sample size of 64 participants
Imputation of missing data: per‐protocol analysis and available‐case analysis (i.e. including only data from participants who participated in at least 5/8 intervention sessions and who answered the post‐treatment measures) + intention‐to‐treat analysis (i.e. including all 64 randomised participants who completed pre‐treatment assessment; including also non‐completing participants and those with missing outcomes); missing data at post‐intervention dealt by using LOCF method
Participants Country: Switzerland
Setting: university students; training setting not specified
Age: mean = 21.35 (SD = 2.53); only psychology students (n = 51): mean = 21.02 (SD = 2. 47); range: 18 ‐34 years
Sample size (randomised): 64, including 51 psychology students
Sex: 56 women, 8 men (total sample); only psychology students (n = 51): 46 women, 5 men
Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline:

  • structure diagnostic interview (Mini‐International Neuropsychiatric Interview) and participants with psychopathological disorders are excluded; MINI lifetime diagnostic: past depression: total sample: 5 (7.8%), IG: 1 (3.1%), CG: 4 (12%); panic disorder: total sample: 2 (3.1%), IG: 1 (3.1%), CG: 1 (3.1%); PTSD: total sample: 1 (1.6%), IG: /, CG: 1 (3.1%)

  • depression (BDI‐II): IG: 5.96 (4.19), CG: 6.22 (5.50); both groups without depression (below cut‐off for mild depression (< 12))

  • state anxiety (State‐Trait Anxiety Inventory, STAI‐S): IG: 31.19 (7.42), CG: 32.06 (9.12); both groups below cut‐off for mild anxiety (< 36)

  • social anxiety (LSAS‐SR): IG: 38.27 (19.72), CG: 41.44 (25.15); both groups below cut‐off for low social anxiety (< 56)

  • mental health screening (Symptom Checklist, SCL‐27‐plus):

    • social phobia: IG: 1.30 (0.75), CG: 1.68 (0.93); both groups below cut‐off (1.86)

    • vegetative: IG: 1.07 (0.55), CG: 1.23 (0.56); both groups below cut‐off (1.54)

    • pain: IG: 1.43 (0.71), CG: 1.61 (0.66); both groups below cut‐off (1.77)

    • agoraphobic: IG: 0.45 (0.53), CG: 0.61 (0.51); both groups below cut‐off (0.93)

    • current depression: IG. 0.52 (0.47), CG: 0.62 (0.61); both groups below cut‐off (1.28)


Population description: university students (majority psychology students)
Inclusion criteria: see also trial registration: 1) being older than 18 years old; 2) having a good understanding of French or German; 3) being a student at the University Fribourg; 4) for the other parts of the study: being right‐handed
Exclusion criteria: 1) presence of an endocrinological condition, history or presence of a neurological disorder or brain injury; 2) use of psychotropic drugs; 3) presence of a mental disorder; 4) participating in another psychological intervention or any type of therapy or coaching and participating in the longitudinal part of this study; 5) for the other parts of the study: general MRI exclusion criteria, i.e. presence of claustrophobia, being pregnant (tested with a pregnancy test), metal in the body (pacemakers, aneurysm's clips, metallic prosthesis, cochlear implant…)
Attrition (withdrawals and exclusions): 1 withdrawal in IG (did not begin intervention)
Reasons for missing data: not specified
Interventions Intervention: multidimensional stress intervention/prevention programme (n = 32)

  • delivery: face‐to‐face; group setting (maximum of 8 students); activities provided printed or on CD; intervention intended to be as experiential as possible: participants sometimes work alone, in pairs, in subgroups or in plenum; written exercises, discussions, role playing in personal or fictive situations; different types of material and triggers used: e.g. videos, audio, visual supports; at end of each exercise: plenary discussion and short theoretical link

  • providers: led by 2 trained clinical psychologists; programme is manualised; throughout entire programme, external psychotherapists available for supervision when needed

  • duration of treatment period and timing: 8 weekly 2‐hour sessions; homework between sessions proposed

  • description:

    • OBJECTIVE: not only to experiment with several techniques to prevent and to cope with stress, but also to increase resources of being more resilient against stress that the participants could use as psychological tools in their everyday life; programme integrates mindfulness‐based activities, cognitive and behavioural strategies, social skills exercises, and emotional regulation

    • CONTENT OF PROGRAMME/SESSIONS: 1) organisational matters and programme overview; stress, triggers, and coping strategies; 2) cognitive and body techniques, mindfulness‐based exercises; 3) cognitive and body techniques; 4) cognitive techniques; 5) emotion and emotion regulation; 6) emotion regulation; 7) social skills and assertiveness; 8) social skills and assertiveness; evaluation of the programme and personal goals

    • FIRST SESSION: participants present themselves, rules of group functioning are discussed, confidentiality document signed; personal experience of stressful situations, triggered emotions, coping strategies, and their efficacy are discussed; participants’ experience with stress = basis to introduce theoretical information about the topic

    • EACH SESSION FOLLOWS THE SAME STRUCTURE: a) 2 ‐ 8. session: start with brief breathing exercise; b) summary of former meeting and objectives of new session are presented; c) review of homework; d) starting with new content; e) end of each session: proposal of homework and participants answer questionnaires about group cohesion and therapeutic alliance

    • SESSIONS 2 ‐ 4: behavioural and cognitive techniques (e.g. breathing exercises; planning and cognitive restructuring) and mindfulness‐based exercises (e.g. awareness of breath meditation; exercises for living in the present moment)

    • SESSIONS 5 ‐ 6: topic of emotions and emotion regulation

    • SESSIONS 7 ‐ 8: integrate assertiveness training and social skills components (e.g. validating communication; interpersonal conflict resolution)

  • compliance: 1/32 did not attend any sessions; i.e. only 31 began the intervention; participants present in sessions varied from 5 (1 person) to all session (11 students); most students (70%) attended 7 or 8 sessions, 25% of students were present at 6 and all of them finished the treatment

  • integrity of delivery: programme is manualised; each session protocoled by masters‐level student to ensure compliance with programme; throughout entire programme, external psychotherapists available for supervision when needed

  • economic information: for their participation, the students received money (CHF 100) or experimental hour compensation (for psychology students)

  • theoretical basis:

    • combined intervention: mindfulness‐based activities, cognitive and behavioural strategies, social skills exercises, and emotional regulation; integrates validated techniques from different approaches (Freiburger Training gegen Leistungsstress, including cognitive behavioural techniques; RFSM‐e‐MOTION (RFSM, Réseau Fribourgeois de Santé Mental, i.e. Fribourg Mental Health Network))

    • RFSM‐e‐MOTION intervention = validated online programme for relatives of individuals with mental disorders that focuses on the emotional aspects of the family members’ experiences and their relationship with the suffering person (see rfsm-e-motion.ch), this programme is based on Dialectical behavioural therapy


Control: wait‐list control (n = 32)

  • compliance: no withdrawals from control group; possibility to participate in IG if they wished so, but finally none of them participated (lack of time)

  • economic information: for their participation, the students received money (CHF 100) or experimental hour compensation (for psychology students)
Outcomes Outcomes collected and reported:

  • mental health problems, social phobia ‐ SCL‐27‐plus

  • mental health problems, vegetative ‐ SCL‐27‐plus

  • mental health problems, pain ‐ SCL‐27‐plus

  • mental health problems, agoraphobic ‐ SCL‐27‐plus

  • mental health problems, current depression ‐ SCL‐27‐plus

  • depression ‐ BDI‐II

  • trait anxiety ‐ STAI‐S

  • state anxiety ‐STAI‐S

  • social anxiety ‐ LSAS‐SR

  • progress of course of therapy, symptom distress ‐ Outcome Questionnaire (OQ ‐45.2)

  • progress of course of therapy, interpersonal relationships ‐ OQ ‐45.2

  • progress of course of therapy, social role ‐ OQ ‐45.2

  • progress of course of therapy, total score (functional problems) ‐ OQ ‐45.2

  • quality of life total ‐ WHOQOL‐BREF

  • quality of life, psychological ‐ WHOQOL‐BREF

  • quality of life, physical ‐ WHOQOL‐BREF

  • quality of life, social ‐ WHOQOL‐BREF

  • quality of life, environmental ‐ WHOQOL‐BREF

  • self‐efficacy ‐ GSEQ

  • sense of coherence ‐ Sense of Coherence Scale

  • self‐compassion ‐ Self‐compassion scale Short Form

  • perceived social support ‐ Multidimensional Scale of Perceived Social Support


Time points measured and reported: 1) pre‐intervention (maximum of 2 weeks before start of intervention); 2) post‐intervention (maximum of 2 weeks after end of the intervention); according to trial registration also assessments at 3‐month and 6‐month follow‐up (i.e. 3 and 6 months post‐intervention) in certain cohorts
Adverse events: not specified
Notes Contact with authors: We contacted the authors for the subgroup outcome data (i.e. means, SDs and number of participants analysed) for all outcomes for psychology students (Recabarren 2019 [pers comm]).
Study start/end date: data collection between March 2015 – March 2017 (see also trial registration)
Funding source: supported by the research pool of the University of Fribourg (grant number 578)
Declaration of interest: research conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest
Ethical approval needed/obtained for study: accepted by the Ethics Committee of the Cantons of Vaud and Fribourg (Protocol 261/14)
Comments by study authors: registered in the research register of the University of Fribourg FUTURA (Project number 6239; http://admin.unifr.ch/futura/content/ projects/6239) as well as in the Clinicaltrial Register (clinicaltrials.gov.NCT03861013)
Miscellaneous outcomes by the review authors: subgroup data for psychology students were sent by the authors
Correspondence: Romina Evelyn Recabarren; Division of Clinical and Health Psychology, IReach Lab, Department of Psychology, University of Fribourg, Fribourg, Switzerland; rominaevelyn.recabarren@unifr.ch
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "After that, participants were randomly distributed in the intervention or the wait‐list control group. The randomization was done using a free available software, i.e., www. randomization.com"
Quote: "No significant differences were found in the sociodemographic variables between the participants of the wait‐list control group and of the intervention groups (all p >0.05) [age: t (62) = −0.393, p = 0.696; sex: X 2 (1) = 0.571, p = 0.450; socioeconomic position: Cramer’s V = 0.135, p = 0.769; studies (psychology and other): X 2 (1) = 0.097, p = 0.756]."
Judgement comment: The investigators describe a random component in the sequence‐generation process (randomisation software); verified baseline comparability of groups for some sociodemographic characteristics (age, sex, socioeconomic position, studies); baseline comparability for other sociodemographic variables (e.g. marital status) and outcomes of interest not specified on the basis of analysis
Allocation concealment (selection bias) Unclear risk Quote: "After that, participants were randomly distributed in the intervention or the wait‐list control group. The randomization was done using a free available software, i.e., www. randomization.com and was archived in an electronic document saved separately."
Judgement comment: insufficient information about allocation concealment to permit judgement of ‘Low risk’ or ‘High risk’ (method of concealment is not described in sufficient detail: "archived in electronic document saved separately"; unclear if random‐sequence allocation was concealed from personnel and/or participants)
Blinding of participants and personnel (performance bias)
Subjective outcomes High risk Quote: "After randomization had been done and due to the design of the study, investigators and participants were not blinded about group allocation."
Judgement comment: no blinding of participants and personnel (face‐to‐face intervention), and the outcome is likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias)
Subjective outcomes High risk Judgement comment: blinding of interviewers for structure diagnostic interview on psychopathological disorders at baseline ensured; insufficient information about blinding of outcome assessment (online questionnaires); but due to performance bias (no blinding of participants), the review authors judge that the participants' responses to questionnaires may be affected by the lack of blinding (i.e. knowledge and beliefs about intervention they received)
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "We analyzed our data using the per‐protocol (PP) approach (108). In that respect, we calculated the ANOVA analyses but only with data from participants who participated in at least five of the eight intervention sessions and who answered the post‐treatment measures. Considering the completion of post‐ treatment measures and according to the dependent variable considered, the sample of post‐treatment participants for the PP‐analyses varies from 56 to 60."
Quote: "To increase the confidence of our results, we performed the same analyses considering an intention‐to‐treat approach (ITT). In the ITT analyses, all randomized participants who completed the pre‐treatment assessment (T1) were taken into account, including non‐completing participants and those with missing outcomes. Missing data at post‐treatment assessment (T2) were dealt by using the last observation carried forward method (LOCF), which in this case correspond to the pre‐ treatment measure (T1) (108). A total of 64 participants were taken account for these analyses."
Judgement comment: unclear if reasons for missing data are related to true outcome (e.g. number of missing data not reported for each group); per‐protocol analysis with participants who participated in at least 5/8 intervention sessions and available‐case analysis (i.e. participants who provided post‐treatment measures) with varying number of participants analysed for each outcome (n = 56 to 60); but also intention‐to‐treat analysis with all randomised participants (n = 64) using LOCF method
Selective reporting (reporting bias) High risk Quote: "This study was registered in the research register of the University of Fribourg FUTURA (Project number 6239; http://admin.unifr.ch/futura/content/ projects/6239) as well as in the Clinicaltrial Register (clinicaltrials.gov.NCT03861013)."
Judgement comment: trial registration available (NCT03861013); not all of the study’s prespecified primary and secondary outcomes have been reported; PRESPECIFIED: Primary outcomes: depression, anxiety (trait/state), sense of coherence, burnout, social anxiety, quality of life, difficulties in emotion regulation, perceived stress, self‐efficacy, mindfulness skills, mental health problems, self‐compassion, perceived social support, reward responsiveness, self‐esteem, reactions after traumatic events, childhood trauma, post‐traumatic stress, cannabis abuse, coping, life orientation/optimism, smartphone addiction, internet addiction, changes in participant's progress through the course of the therapy; Secondary outcomes: ambulatory assessment, answer to reward task, cortisol levels in daily life and laboratory task; Other outcomes: socio‐economic position index, information about relatives, handedness, nicotine dependence, psychotherapy alliance, quality of the group relationship, academic success, change in psychopathological disorders; REPORTED: mental health problems, depression, anxiety (trait/state), social anxiety, changes in participant's progress through the course of the therapy, quality of life, self‐efficacy, sense of coherence, self‐compassion, perceived social support