Brief Culturally Adapted Behavioral Activation Therapy for Adults With Depression in Rural Indonesian Primary Care: A Type-2 Hybrid Effectiveness-Implementation Trial

NCT07373080 | Not Yet Recruiting

• 1 other identifier: 3415/UN1/PS.1/SD/PT.01.04/2025
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This is a type-2 hybrid effectiveness-implementation study of brief culturally adapted behavioral activation for adults with depression in primary care setting. This clinical trial has two parallel aims: 1) to understand if brief culturally adapted behavioral activation therapy delivered by psychologist in primary care in individual face-to-face session is effective to reduce depressive symptoms among adult patients in Primary Healthcare Centers and 2) to test the outcome of clinical training and supervision on acceptability, feasibility, appropriateness, and fidelity of implementation of brief culturally adapted behavioral activation therapy in Primary Healthcare Centers. The main questions it aims to answer is: 1\) Is brief culturally adapted behavioral activation intervention delivered by primary care psychologist effective in reducing depressive symptoms among adult patients with depression in primary care settings and 2) Are training and supervision effective in enhancing acceptability, feasibility, appropriateness and fidelity of implementation of brief culturally adapted behavioral activation therapy for adults with depression in primary care settings?

Conditions

Depression in Adults

Keywords

depression; behavioral activation therapy; culturally adapted treatment; implementation science; hybrid trial

Outcome Measures

Primary Outcomes (6)

• Change from Baseline in Depressive Symptoms as Assessed by Patient Health Questionnaire-9 (PHQ-9) at 1 Week after Intervention

  Participants will fill the PHQ-9 as self-reported questionnaire using paper and pencil format, administered by research assistant. PHQ-9 consists of nine items with four response from 'not at all' (0) to 'nearly every day' (3). The score of the PHQ-9 ranges from 0 to 27 with higher score indicating higher depressive symptoms.

  Baseline and 1 week post intervention

• Participant's Acceptability of Intervention as Assessed by Client Satisfaction Questionnaire-8 (CSQ-8)

  Acceptability is defined as the participant's perception that a given treatment is agreeable, palatable, or satisfactory and will be measured using CSQ-8. CSQ-8 consists of 8 items with four optional responses. The score of the questionnaire will range from 1 to 32 with higher score indicating acceptability of intervention.

  Post intervention (immediately after intervention completed)

• Clinical Provider's Perceived Acceptability as Assessed by Acceptability of Intervention Measure (AIM)

  Acceptability is defined as the clinical provider's perception that a given treatment is agreeable, palatable, or satisfactory and will be measured by Acceptability of Intervention Measure (AIM). AIM consists of four items with five Likert-based responses. The score of the scale will range from 1 to 20 with higher score indicating higher acceptability to the intervention.

  through study completion, an average of 3 months

• Clinical Provider's Perceived Feasibility as Assessed by Feasibility of Intervention Measure (FIM)

  Feasibility is defined as the perceived extent to which the intervention can be successfully used or carried out in primary care setting from participants and clinical providers' perspectives and will be measured by Feasibility of Intervention Measure (FIM). FIM consists of four items with five Likert-type responses. The score of the scale will range from 1 to 20 with higher score indicating higher feasibility of the intervention.

  through study completion, an average of 3 months

• Clinical Provider's Perceived Appropriateness as Assessed by Intervention Appropriateness Measure (IAM)

  Appropriateness is defined as the perceived fit, relevance, or compatibility of brief culturally adapted behavioral activation for adults with depression in primary care setting from participant's and clinical provider's perspectives, and measured by Intervention Appropriateness Measure (IAM). IAM consists of four items with five Likert-based responses. The score of the scale will range from 1 to 20 with higher score indicating higher appropriateness of the intervention.

  through study completion, an average of 3 months

• Qualitative Feedback on Acceptability, Feasibility, and Appropriateness from Participants and Clinical Providers as Assessed using Semi-structured Interview

  Participants and clinical providers will be asked about their experiences in receiving or providing the intervention through individual qualitative interview to understand their perceived acceptability, feasibility, and appropriateness in a more detailed and comprehensive way.

  From enrollment to 1 week after intervention completed (for participants) through study completion, an average of 3 months (for clinical providers)

Secondary Outcomes (7)

• Rate of Remission or Recovery of Depression Diagnosis as Assessed by Structured Clinical Interview for DSM-5 (SCID-5) at 1 Week after Intervention

  Post-intervention (1 week after intervention completed)

• Change in Quality of Life from Baseline as Assessed by WHO Quality of Life Brief Version (WHOQOL-BREF) at 1 Week after Intervention

  Baseline (week 0) and post-intervention (1 week after intervention completed)

• Change from Baseline in Anxiety as Assessed by Generalized Anxiety Disorder-7 (GAD-7) at 1 Week after Intervention

  Baseline (week 0) and post-intervention (1 week after intervention completed)

• Rate of Remission or Recovery in Depression Diagnosis 1-month after Intervention as Assessed by Structured Clinical Interview for DSM-5 (SCID-5)

  One month after intervention

• Change in Depressive Symptoms 1-month after Intervention as Assessed by Patient Health Questionnaire-9 (PHQ-9)

  Baseline (week 0) and 1-month after intervention

Other Outcomes (1)

• Change in Behavioral Activation as Assessed by Behavioral Activation for Depression Scale - Short Form (BADS-SF)

  Every week during the trial from baseline to post-intervention (week 0, 1, 2, 3, and 4)

Study Arms (2)

BAT Implementation Arm

EXPERIMENTAL

Twelve primary health centers will be randomized into BAT implementation arm or TAU arm equally. Six selected primary care psychologists from six primary health centers will receive 4-session online training and 2-session booster training on BAT as well as synchronous (biweekly) and asynchronous (throughout implementation) online supervision from local and international experts. Forty-eight participants (adult patients) from six primary health centers will receive individual face-to-face Brief Culturally Adapted Behavioral Activation Therapy (3 sessions).

Other: Training and supervisionon BAT

TAU (Treatment-as-usual)

NO INTERVENTION

Six primary health centers will be grouped into control arm using online randomizer. No implementation strategy applied for these clusters. Forty-eight participants (adult patients) from six primary health centers will receive treatment-as-usual for depression from primary care psychologist with no restriction on intervention approach and number of sessions.

Interventions

Training and supervisionon BAT OTHER

Implementation strategy: Training and Supervision Training: Primary care psychologists will receive training which consists of 4-session online training of Behavioral Activation Therapy (BAT), 2-session of booster training focusing on BA principle and therapy protocol, and clinical practice with 2 participants during pilot study. Four-session online training, 1 booster session, and clinical practice with 2 participants have been delivered during pilot study phase. Supervision: Supervision will be provided during BAT implementation in two forms: 1) biweekly synchronous online supervision, starting from week 3 after the first day of recruitment and 2) asynchronous online supervision through online shared spreadsheet, available throughout BAT implementation. Participants in BAT implementation arm will receive 3 individual face-to-face sessions of Brief Culturally Adapted Behavioral Activation Therapy.

BAT Implementation Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18-65 years old
• scored 10 or above on PHQ-9
• provide informed consent

You may not qualify if:

• having diagnosis of bipolar disorder, psychotic disorders, or substance use disorders

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (1)

Puskesmas (Primary Healthcare Center)

Sleman, Special Region of Yogyakarta, Indonesia

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-arms parallel cluster randomized controlled trial, hybrid effectiveness-implementation trial type-2 with mixed method

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 28, 2026
• Study Start: February 9, 2026
• Primary Completion: April 4, 2026
• Study Completion: May 2, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning at publication date with no end date
• Access Criteria: The IPD and supporting information will be shared through Open Science Framework (OSF) Platform.

Locations

ID (1)