Comparison of the effectiveness of culturally adapted game-based behavioral activation therapy (CA-BAPT) and cognitive behavioral therapy in reducing anhedonia among adolescents
To evaluate the effectiveness of Culturally Adapted Behavioral Activation Play Therapy (CA BAPT) compared with Cognitive Behavioral Therapy (CBT) in reducing anhedonia and improving adolescent mental health outcomes
Design
Two arm parallel group pragmatic cluster quasi experimental study with clinic level allocation; non randomized allocation after clinic pair matching; single blind outcome assessment; total sample size 900; phase not applicable
Settings and conduct
Conducted in 30 community mental health clinics; assessments at baseline; posttreatment at week 12; 3 month follow up; outcome assessors and statistical analysts were blinded to group allocation and participants were asked not to disclose their condition during assessments
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adolescents aged 13 to 18 years with moderate to high anhedonia based on the Snaith Hamilton Pleasure Scale; able to read Persian; written consent from the adolescent and a parent or legal guardian. Exclusion criteria: active psychotic disorders; severe cognitive or developmental impairment; concurrent participation in other psychological treatments
Intervention groups
Intervention group received twelve 60 minute group sessions of CA BAPT integrating behavioral activation skills with culturally relevant play based activities; two parent psychoeducation sessions Control group received twelve 60 minute group CBT sessions based on a standardized adolescent protocol
Main outcome variables
Anhedonia severity based on the Snaith Hamilton Pleasure Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20251116068014N3
Registration date:2026-04-05, 1405/01/16
Registration timing:prospective
Last update:2026-04-05, 1405/01/16
Update count:0
Registration date
2026-04-05, 1405/01/16
Registrant information
Name
khatereh Arbabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2294 2918
Email address
arbabikhatere@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-04-21, 1405/02/01
Expected recruitment end date
2026-05-04, 1405/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of culturally adapted game-based behavioral activation therapy (CA-BAPT) and cognitive behavioral therapy in reducing anhedonia among adolescents
Public title
Effect of culturally adapted behavioral activation play therapy on adolescent mental health
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 13 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
900
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medical Sciences, Islamic Azad University, Qom
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
Secondary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
Intervention groups
1
Description
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.
Category
Behavior
2
Description
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.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
White Rose Psychological Chain Clinics affiliated with Imam Khomeini Relief Foundation
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
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 data/document is available
Qualified researchers affiliated with academic or research institutions who submit a reasonable and methodologically sound proposal.
Under which criteria data/document could be used
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.
From where data/document is obtainable
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.
What processes are involved for a request to access data/document
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.