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Depression in AdultsNCT07373080

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

A study testing Training and supervision on BAT in people with Depression in Adults, run by Gadjah Mada University at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depression in Adults
What is being tested?
Training and supervision on BAT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteIndonesia
Study dates
11 Feb 2026to 31 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • Puskesmas (Primary Healthcare Center)

    Sleman, Special Region of Yogyakarta

Other trials in Indonesia

About this study

Official 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

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?
Read the detailed 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.

Being tested
Training and supervision on BAT
Keywords
depression, behavioral activation therapy, culturally adapted treatment, implementation science, hybrid trial
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training and supervision on BATOther

    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.

Study groups in NCT07373080
Study groupRoleWhat they receive
BAT Implementation ArmExperimentalTwelve 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).
Receives: Other: Training and supervision on BAT
TAU (Treatment-as-usual)No interventionSix 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline and 1 week post intervention

  2. Participant's Acceptability of Intervention as Assessed by the 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 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 8 to 32 with higher score indicating acceptability of intervention.

    Measured: Post intervention (immediately after intervention completed)

  3. 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.

    Measured: through study completion, an average of 3 months

  4. 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.

    Measured: through study completion, an average of 3 months

  5. 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.

    Measured: through study completion, an average of 3 months

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

    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.

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

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

    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.

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

Secondary outcomes (8)
  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

    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).

    Measured: Post-intervention (1 week after intervention completed)

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

    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.

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

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

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

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

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

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

    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).

    Measured: One month after intervention

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

    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.

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

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

    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.

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

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2026
  2. Study start11 Feb 2026
  3. Primary completion31 Jul 2026
  4. Study completion31 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-arms parallel cluster randomized controlled trial, hybrid effectiveness-implementation trial type-2 with mixed method
Masking
None (open label)
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07373080
Sponsor's protocol ID
3415/UN1/PS.1/SD/PT.01.04/2025
Status last verified
May 2026
First submitted
13 Jan 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD with supported informed consent that underlie results in a publication will be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Training and supervision on BAT in people with Depression in Adults, run by Gadjah Mada University at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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