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

Gadjah Mada University

Status: Begins enrollment this month

Conditions: Depression in Adults

Treatments: Other: Training and supervisionon BAT

Study type: Interventional

Funder types: Other

Identifiers

NCT07373080

3415/UN1/PS.1/SD/PT.01.04/2025

Details and patient eligibility

About

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?

Full description

Depression is among global burden of diseases with higher treatment gap in lower- and middle-income countries (LMICs), including Indonesia. Integrating mental health care into primary care is one of recommended strategy to close the treatment gap in LMICs and there has been such integration through the placement of primary care psychologist in one of rural districts in Indonesia. In the other hand, behavioral activation therapy (BAT) is a culturally adaptable evidence-based therapy for adults with depression. However, little is known about implementation strategy to enhance the adoption of BAT as well as its clinical effectiveness in Indonesian primary care.

This study aims to: 1) test clinical effectiveness of BAT with prior systematic cultural adaptation in reducing depressive symptoms among adults with depression in primary care and 2) test the effect of implementation strategies (i.e., training and supervision) on implementation outcomes (i.e., acceptability, feasibility, appropriateness, and fidelity). The results of this study will inform further study to scale up BAT implementation in Indonesian primary care settings.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

BAT Implementation Arm

Experimental group

Description:

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).

Treatment:

Other: Training and supervisionon BAT

TAU (Treatment-as-usual)

No Intervention group

Description:

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.