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IRCT20251116068014N3 IRCT 2026-04-05 White Rose Psychological Chain Clinics affiliated with Imam Khomeini Relief Foundation Effect of culturally adapted behavioral activation play therapy on adolescent mental health Comparison of the effectiveness of culturally adapted game-based behavioral activation therapy (CA-BAPT) and cognitive behavioral therapy in reducing anhedonia among adolescents 2026-04-21 anticipated 900 Complete https://irct.ir/trial/88950 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study will be conducted as a pragmatic cluster-based study in service delivery centers, and the unit of allocation will be the center or clinic. Due to operational constraints within routine service settings, cluster-level randomization will not be performed, and allocation of clusters will take place after matching centers based on cluster size, geographic location, baseline mean anhedonia, and gender ratio, while also considering service delivery feasibility. Assessments will be conducted at four time points, including baseline, end of intervention, and a three-month follow-up. To enhance reporting transparency, the study will be reported in accordance with the TREND guideline for nonrandomized evaluations and the StaRI framework addressing real-world implementation and delivery considerations. Analyses will follow the intention-to-treat principle, missing data will be handled using multiple imputation, and intervention effects will be estimated using multilevel mixed models accounting for the cluster structure, with matching variables controlled for in the models, Blinding description: Because of the nature of group-based psychological interventions, blinding of participants and therapists will not be feasible, and participants will be aware that they are taking part in a research study. However, outcome assessors, the data management team, and statistical analysts will be kept blinded to group allocation. Data will be collected by assessors who will not be informed about the type of intervention delivered at each center, and participants will be instructed not to disclose their intervention type during assessments. Statistical analyses will be conducted using coded data without identification of group allocation. The principal investigator and therapists will not be blinded to group allocation due to their operational roles in delivering the interventions. No independent data safety monitoring committee will be established because the study will be non-pharmacological and designed to involve minimal psychological risk. N/A Anhedonia in adolescents. Intervention 1: Intervention group: Participants in the intervention group will receive culturally adapted game-based behavioral activation therapy in a group format. The intervention will consist of twelve weekly 60-minute sessions that will be delivered by trained clinical psychologists. The intervention program will be based on behavioral activation principles and will use game-based, experiential, and interactive activities adapted to adolescents’ cultural context and developmental stage. Core components will include increasing engagement in pleasurable and value-based activities, reducing avoidance patterns, strengthening social interactions, and facilitating emotional expression through structured group games and exercises. In addition, two structured parent sessions will be conducted, focusing on supporting adolescents’ engagement in adaptive activities and reinforcing therapeutic goals within the family environment. Intervention 2: Control group: Participants in the control group will receive group-based cognitive behavioral therapy. The intervention will consist of twelve weekly 60-minute sessions that will be delivered by trained clinical psychologists. The treatment will be designed based on the standard cognitive behavioral therapy protocol for adolescents, and its core components will include identification and modification of dysfunctional thoughts, training in emotion regulation skills, problem-solving skills, and strengthening adaptive coping strategies. Sessions will be conducted in a structured format in accordance with principles of group cognitive behavioral therapy. Yes - There is a plan to make this available What will be shared: De-identified individual participant data including primary and secondary outcome measures; data dictionary; study protocol; statistical analysis plan; analysis codes. All shared datasets will be fully anonymised and will not contain any direct or indirect identifiers. When: Data will be available starting 6 months after publication of the primary results and will remain accessible for a minimum period of 5 years. To whom: Qualified researchers affiliated with academic or research institutions who submit a reasonable and methodologically sound proposal. Conditions: Data may be used solely for non-commercial scientific research purposes, including secondary analyses, meta-analyses, or methodological studies. Use of data requires approval of the study team, adherence to ethical standards, and signing of a data use agreement prohibiting re-identification and data redistribution. Where to obtain: Requests should be submitted to the corresponding investigator via email. Contact details will be provided upon publication and are available through the affiliated research center. How to obtain: Applicants submit a written request including research objectives and analysis plan. Requests are reviewed by the study team within approximately 4 to 6 weeks. Upon approval and completion of a data use agreement, access to the requested materials will be granted. Comments: No identifiable data will be shared. Data sharing will comply with ethical approvals and national regulations regarding research involving adolescents.
public Khatereh Arbabi
No. 33, Rasoulian Street, Zabti Street, Heravi Avenue, Tehran, Iran
Tehran Iran (Islamic Republic of) 1667838614 +98 21 2294 2918 arbabikhatere@gmail.com White Rose Psychological Chain Clinics affiliated with Imam Khomeini Relief Foundation scientific Khatereh Arbabi
No. 33, Rasoulian Street, Zabti Street, Heravi Avenue, Tehran, Iran
Tehran Iran (Islamic Republic of) 1667838614 +98 21 2294 2918 arbabikhatere@gmail.com White Rose Psychological Chain Clinics affiliated with Imam Khomeini Relief Foundation Iran (Islamic Republic of) Adolescents aged 13 to 18 years Moderate to high levels of anhedonia based on the Snaith–Hamilton Pleasure Scale Ability to read and understand Persian Written informed consent obtained from the adolescent Written informed consent obtained from a parent or legal guardian Willingness to participate in group based psychological sessions 13 years 18 years Both Presence of active psychotic disorders Severe cognitive impairment or severe developmental disorder interfering with effective participation Concurrent participation in other psychological or psychotherapeutic interventions Inability to cooperate with study assessments based on clinical judgment Behavior Behavior Intervention group: Participants in the intervention group will receive culturally adapted game-based behavioral activation therapy in a group format. The intervention will consist of twelve weekly 60-minute sessions that will be delivered by trained clinical psychologists. The intervention program will be based on behavioral activation principles and will use game-based, experiential, and interactive activities adapted to adolescents’ cultural context and developmental stage. Core components will include increasing engagement in pleasurable and value-based activities, reducing avoidance patterns, strengthening social interactions, and facilitating emotional expression through structured group games and exercises. In addition, two structured parent sessions will be conducted, focusing on supporting adolescents’ engagement in adaptive activities and reinforcing therapeutic goals within the family environment. Control group: Participants in the control group will receive group-based cognitive behavioral therapy. The intervention will consist of twelve weekly 60-minute sessions that will be delivered by trained clinical psychologists. The treatment will be designed based on the standard cognitive behavioral therapy protocol for adolescents, and its core components will include identification and modification of dysfunctional thoughts, training in emotion regulation skills, problem-solving skills, and strengthening adaptive coping strategies. Sessions will be conducted in a structured format in accordance with principles of group cognitive behavioral therapy. Anhedonia severity score in adolescents based on the Snaith Hamilton Pleasure Scale. Timepoint: Assessment at baseline before intervention; posttreatment at week 12; 3 month follow up. Method of measurement: Anhedonia severity measured using the Snaith Hamilton Pleasure Scale self report questionnaire validated for adolescents. Adolescent stress severity score. Timepoint: Assessment at baseline before intervention; posttreatment at week 12;3 month follow up. Method of measurement: Stress severity is measured using the Adolescent Stress Questionnaire, developed by Susan M. Byrne and colleagues, which has been validated for use in adolescent populations. Psychological well being score in adolescents. Timepoint: Assessment at baseline before intervention; posttreatment at week 12; 3 month follow up. Method of measurement: Psychological well being is measured using the Mental Health Continuum Short Form self report questionnaire, developed by Corey L. M. Keyes, which has been validated for use in adolescent populations. Resilience score in adolescents. Timepoint: Assessment at baseline before intervention; posttreatment at week 12;3 month follow up. Method of measurement: Resilience is measured using the Child and Youth Resilience Measure Revised, revised by Polly Jefferies and colleagues, and validated for use in adolescent populations. Sleep hygiene score in adolescents. Timepoint: Assessment at baseline before intervention; posttreatment at week 12; 3 month follow up. Method of measurement: Sleep hygiene is measured using the Adolescent Sleep Hygiene Scale Revised, developed by Monika K. LeBourgeois and colleagues, and validated for use in adolescent populations. White Rose Psychological Chain Clinics affiliated with Imam Khomeini Relief Foundation Approved 2025-11-05 Faculty of Medical Sciences, Islamic Azad University, Qom No. 33, Rasoulian Street, Zabti Street, Heravi Avenue, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)