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NCT Number: NCT07373080

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

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?

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Puskesmas (Primary Healthcare Center)

Sleman, Special Region of Yogyakarta, Indonesia

Location status: Recruiting

Location contact

Health Office of Sleman Regency

CONTACT

[email protected]

+6285123872878

Salma Salma, M.Psi., Psikolog

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training and supervision on 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.

No specific drug or device used during the interventions.

Primary outcomes

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

    Time frame: Baseline and 1 week post intervention

    Participants will fill the Patient Health Questionnaire-9 (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.

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

    Time frame: Post intervention (immediately after intervention completed)

    Acceptability is defined as the participant's perception that a given treatment is agreeable, palatable, or satisfactory and will be measured using the Client Satisfaction Questionnaire-8 (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.

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

    Time frame: through study completion, an average of 3 months

    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.

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

    Time frame: through study completion, an average of 3 months

    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.

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

    Time frame: through study completion, an average of 3 months

    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.

  6. Qualitative Feedback on Acceptability, Feasibility, and Appropriateness from Participants as Assessed using Semi-structured Interview

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

    Participants 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.

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

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

    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.

Secondary outcomes

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

    Time frame: Post-intervention (1 week after intervention completed)

    Rate of remission or recovery will be calculated in percentage based on result of SCID-5 interview, administered by primary care psychologist. The result of clinical interview will categorize the participants into active depression or in remission or no diagnosis (fully recovered).

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

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

    The level of behavioral activation among participants will be tracked through the course of treatment using BADS-SF. Participants will fill the BDS-SF every week at the treatment scheduled time. BADS-SF consists of 9 items with response on each item ranging from 0 to 6. The score of the BADS-SF will range from 0 to 54 with higher score indicating higher activation.

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

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

    Participants will fill the WHOQOL-BREV as self-reported questionnaire using paper and pencil format, administered by research assistant. WHOQOL-BREV consists of 26 items with score on each item ranges from 0 to 5. The scale will produce quality of life profile which consists of overall perception of individual's quality of life, overall perception of individual's health, and four quality of life domains (physical health, psychological, social relationship, and environment). The score is calculated using mean score of each domain, then transformed to 4-20. Higher score of the domain indicates higher quality of life.

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

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

    Anxiety is measured using Generalized Anxiety Disorder-7 (GAD-7) as a self-reported questionnaire using paper and pencil format, administered by research assistant. GAD-7 consists of seven items with four response on each item ranging from 0 to 4. The score of GAD-7 will range from 0 to 21 with higher score indicating higher anxiety.

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

    Time frame: One month after intervention

    Rate of remission or recovery will be calculated in percentage based on result of SCID-5 interview, administered by primary care psychologist. The result of clinical interview will categorize the participants into active depression or in remission or no diagnosis (fully recovered).

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

    Time frame: Baseline (week 0) and 1-month 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.

  7. Change in Quality of Life 1-month after Intervention as Assessed by WHO Quality of Life Brief Version (WHOQOL-BREF)

    Time frame: Baseline (week 0) and 1-month after intervention

    Participants will fill the WHOQOL-BREV as self-reported questionnaire using paper and pencil format, administered by research assistant. WHOQOL-BREV consists of 26 items with score on each item ranges from 0 to 5. The scale will produce quality of life profile which consists of overall perception of individual's quality of life, overall perception of individual's health, and four quality of life domains (physical health, psychological, social relationship, and environment). The score is calculated using mean score of each domain, then transformed to 4-20. Higher score of the domain indicates higher quality of life.

  8. Change in Anxiety 1-month after Intervention as Assessed by Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: Baseline (week 0) and 1-month after intervention

    Anxiety is measured using Generalized Anxiety Disorder-7 (GAD-7) as a self-reported questionnaire using paper and pencil format, administered by research assistant. GAD-7 consists of seven items with four response on each item ranging from 0 to 4. The score of GAD-7 will range from 0 to 21 with higher score indicating higher anxiety.

Sponsors and collaborators

Lead sponsor

Gadjah Mada University

Other

Registry information

Official study title

Hybrid Type-2 Effectiveness-Implementation Study of Brief Culturally Adapted Behavioral Activation Therapy Delivered by Primary Care Psychologists for Adults With Depression in Indonesian Primary Care Setting: A Study Protocol of Pragmatic Parallel Cluster Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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