Depression in AdultsNCT07120893
Pilot Study of Brief Culturally Adapted Behavioral Activation for Adults With Depression in Primary Care Setting
A study testing brief culturally adapted behavioral activation in people with Depression in Adults, run by Gadjah Mada University at 1 site in Indonesia.
Trial 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… 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?
- brief culturally adapted behavioral activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIndonesia
- Study dates
- 22 Sep 2025to 20 Jan 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
- scored 10 or above on PHQ-9
- provide informed consent
Who cannot join
- having diagnosed of bipolar disorder, psychotic disorders, or substance abuse disorders
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Puskesmas (Primary Healthcare Center)
Sleman, Special Region of Yogyakarta
About this study
Official title: Pilot Study Assessing Acceptability, Feasibility, and Appropriateness of Brief Culturally Adapted Behavioral Activation for Adults With Depression in Primary Care Setting
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?
Read the 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
- Being tested
- brief culturally adapted behavioral activation
- Keywords
- culturally adapted behavioral activation, depressive disorder, primary care, pilot study
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brief culturally adapted behavioral activationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: brief culturally adapted behavioral activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention (maximum 1 week after intervention completed)
Secondary outcomes (4)
Change in Depressive Symptoms 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 post-intervention (1 week after intervention completed)
Change in Quality of Life 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 post-intervention (1 week after intervention completed)
Change in Anxiety 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 post-intervention (1 week after intervention completed)
Change in Depression Diagnosis as Assessed by Structured Clinical Interview for DSM-5 (SCID-5)
Diagnosis of depression among participants will be compared before and after intervention using SCID-5, administered by primary care psychologist. The result of clinical interview will categorize the participants into active depression or in remission.
Measured: Baseline (week 0) and post-intervention (1 week after intervention completed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start22 Sep 2025
- Primary completion17 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depression in AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Salma, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120893
- Sponsor's protocol ID
- 2396/UN1/PS.1/SD/PT.01.04/2025
- Status last verified
- Jan 2026
- First submitted
- 30 Jul 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared
Publications
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.
PubMed 32628293Richards 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.
PubMed 27461440
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Assessing Acceptability, Feasibility, and Appropriateness of Brief Culturally Adapted Behavioral Activation for Adults With Depression in Primary Care Setting
- ClinicalTrials.gov ID
- NCT07120893
- Acronym / sponsor ID
- 2396/UN1/PS.1/SD/PT.01.04/2025
- Conditions
- Depression in Adults
- Keywords
- culturally adapted behavioral activation, depressive disorder, primary care, pilot study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 17 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: brief culturally adapted behavioral activationThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- scored 10 or above on PHQ-9
- provide informed consent
Key exclusion criteria (1 listed)
- having diagnosed of bipolar disorder, psychotic disorders, or substance abuse disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brief culturally adapted behavioral activationThe 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. | Behavioural | Intervention Arm |
Primary outcome
Participant's and Clinical Provider's Perceived Acceptability as Assessed by Acceptability of Intervention Measure (AIM)
Time frame: Post-intervention (maximum 1 week after intervention)
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.
Participant's and Clinical Provider's Perceived Feasibility as Assessed by Feasibility of Intervention Measure (FIM)
Time frame: Post-intervention (maximum 1 week after intervention completed)
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.
Participant's and Clinical Provider's Perceived Appropriateness as Assessed by Intervention Appropriateness Measure (IAM)
Time frame: Post-intervention (maximum 1 week after intervention completed)
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.
Qualitative Feedback on Acceptability, Feasibility, and Appropriateness from Participants and Clinical Providers as Assessed using Semi-structured Interview
Time frame: Post-intervention (maximum 1 week after intervention completed)
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.
4 secondary outcomes
Change in Depressive Symptoms as Assessed by Patient Health Questionnaire-9 (PHQ-9)
Time frame: 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)
Time frame: Baseline (week 0) and post-intervention (1 week after intervention completed)
Change in Anxiety as Assessed by Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 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)
Time frame: Baseline (week 0) and post-intervention (1 week after intervention completed)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Background: PubMed 32628293Uphoff 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.
- Background: PubMed 27461440Richards 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brief culturally adapted behavioral activation 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 2 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 21 Jul 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?
Participant's and Clinical Provider's Perceived Acceptability as Assessed by Acceptability of Intervention Measure (AIM) (time frame: Post-intervention (maximum 1 week after intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07120893, which also lists 2 linked publications.
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 21 Jul 2026.