Pilot Study of Brief Culturally Adapted Behavioral Activation for Adults With Depression in Primary Care Setting

NCT07120893 | Recruiting

• 1 other identifier: 2396/UN1/PS.1/SD/PT.01.04/2025
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study of culturally adapted behavioral activation for adults with depression in primary care setting. As a pilot study following systematic cultural adaptation process, the purpose of this clinical trial is to understand if brief culturally adapted individual intervention based on behavioral activation, can be an acceptable, feasible, and appropriate intervention to reduce depressive symptoms among adults with depression in primary care setting. The main question it aims to answer is: Is brief culturally adapted behavioral activation intervention delivered by primary care psychologist acceptable, feasible, and appropriate as an evidence based treatment for reducing depressive symptoms among adults with depression in primary care setting?

Conditions

Depression in Adults

Keywords

culturally adapted behavioral activation; depressive disorder; primary care; pilot study

Outcome Measures

Primary Outcomes (4)

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

  Acceptability is defined as the participant's and 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.

  Post-intervention (maximum 1 week after intervention)

• Participant's and 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.

  Post-intervention (maximum 1 week after intervention completed)

• Participant's and 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.

  Post-intervention (maximum 1 week after intervention completed)

• 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.

  Post-intervention (maximum 1 week after intervention completed)

Secondary Outcomes (4)

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

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

• Change in Quality of Life as Assessed by WHO Quality of Life Brief Version (WHOQOL-BREF)

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

• Change in Anxiety as Assessed by Generalized Anxiety Disorder-7 (GAD-7)

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

• Change in Depression Diagnosis as Assessed by Structured Clinical Interview for DSM-5 (SCID-5)

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

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 (1)

Intervention Arm

EXPERIMENTAL

The intervention arm will receive brief culturally adapted behavioral activation therapy, delivered by primary care psychologist, which consists of three individual face-to-face session. The intervention will include both in session activities and homework activity assignment.

Behavioral: brief culturally adapted behavioral activation

Interventions

brief culturally adapted behavioral activation BEHAVIORAL

The brief culturally adapted behavioral intervention in this study is a three individual-session intervention, delivered in primary health care center by primary care psychologist. Each session will last 30-45 minutes in face-to-face. During each session, participants will learn about behavioral techniques to reduce depression and enhance well-being, and practice it in their daily life through homework activities.

Intervention 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:

• scored 10 or above on PHQ-9
• provide informed consent

You may not qualify if:

• having diagnosed of bipolar disorder, psychotic disorders, or substance abuse disorders

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (1)

Puskesmas (Primary Healthcare Center)

Sleman, Special Region of Yogyakarta, Indonesia

RECRUITING

Related Publications (2)

• Uphoff E, Ekers D, Robertson L, Dawson S, Sanger E, South E, Samaan Z, Richards D, Meader N, Churchill R. Behavioural activation therapy for depression in adults. Cochrane Database Syst Rev. 2020 Jul 6;7(7):CD013305. doi: 10.1002/14651858.CD013305.pub2.

  PMID: 32628293 BACKGROUND

• Richards DA, Ekers D, McMillan D, Taylor RS, Byford S, Warren FC, Barrett B, Farrand PA, Gilbody S, Kuyken W, O'Mahen H, Watkins ER, Wright KA, Hollon SD, Reed N, Rhodes S, Fletcher E, Finning K. Cost and Outcome of Behavioural Activation versus Cognitive Behavioural Therapy for Depression (COBRA): a randomised, controlled, non-inferiority trial. Lancet. 2016 Aug 27;388(10047):871-80. doi: 10.1016/S0140-6736(16)31140-0. Epub 2016 Jul 23.

  PMID: 27461440 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 13, 2025
• Study Start: September 22, 2025
• Primary Completion: December 6, 2025
• Study Completion: December 13, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

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)