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

NCT ID: NCT07120893

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-22
• Study Completion Date: 2025-12-13

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?

Detailed Description

This is a pilot study using mixed method and single arm design to assess acceptability, feasibility, and appropriateness of brief culturally adapted behavioral activation for adults with depression in primary care setting. In this study, participants will receive three individual sessions of brief culturally adapted behavioral activation intervention delivered by primary care psychologist. The participants and primary care psychologist will be asked to fill standardized questionnaire before and after intervention. In addition, the investigators will ask them after the intervention about their experience in receiving or delivering the intervention using semi-structured interview. The depressive symptom level and quality of life of the participants before and after the intervention will be compared as secondary outcome. The results of this study will serve as reference to revise the intervention manual before testing it in a hybrid effectiveness-implementation trial or the main trial.

Conditions

Depression in Adults

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Arm

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.

Group Type: EXPERIMENTAL

brief culturally adapted behavioral activation

Intervention Type: 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.

Interventions

brief culturally adapted behavioral activation

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gadjah Mada University

OTHER

Sponsor Role: lead

Responsible Party

Salma Salma

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Puskesmas (Primary Healthcare Center)

Sleman, Special Region of Yogyakarta, Indonesia

Site Status: RECRUITING

Countries

Indonesia

Facility Contacts

Puskesmas in Sleman Regency

Role: primary

dinkes@slemankab.go.id

+6285123872878

References

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.

Reference Type: BACKGROUND

PMID: 32628293 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27461440 (View on PubMed)

Other Identifiers

2396/UN1/PS.1/SD/PT.01.04/2025

Identifier Type: -

Identifier Source: org_study_id