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

Trial statusCompleted
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGadjah Mada University

About this 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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

aged 18-65 years old

scored 10 or above on PHQ-9

provide informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Training and supervision on BAT

    Other intervention

    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.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: BAT Implementation ArmExperimental treatment 1 intervention
Group B: TAU (Treatment-as-usual)No intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
through study completion, an average of 3 months

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

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).

Time frame
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.

Time frame
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.

Time frame
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.

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

Other outcomes

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