Mental Health Assessment Project on the Thailand-Burma Border

NCT ID: NCT01459068

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 347 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-11-30

Brief Summary

The aim of the study is to determine the effectiveness of a transdiagnostic psychotherapy intervention - namely, Common Elements Treatment Approach (CETA) - in reducing the severity of mental health symptoms experienced by torture and violence survivors displaced from Burma into Thailand. Specifically, the intervention seeks to measure reductions (if any) in symptoms of depression and trauma.

Detailed Description

The study is part of an award by the USAID Victims of Torture Fund (USAID/VTF) to JHU to work with local and international organizations serving survivors of torture and systematic violence. For this study, the intent is to assist in the design, implementation, monitoring, and evaluation of programming to understand and address the psychosocial needs of Burmese displaced across the Thai/Burma border who are living in the area of Mae Sot, Tak Province in Thailand. Specifically this project involves collaboration with the Burma Border Projects (BBP), the Mae Tao Clinic (MTC), the Assistance Association for Political Prisoners (AAPP), and Social Action for Women (SAW), to help improve the quality and effectiveness of psychosocial and mental health programs.

The Common Elements Treatment Approach (CETA) is a transdiagnostic treatment approach developed for delivery by lay counselors in low and middle income countries (LMIC) with few mental health professionals. CETA was designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety, and to provide skills to deal with life stressors. includes engagement, psychoeducation, anxiety management strategies, behavioral activation, cognitive coping/restructuring, imaginal gradual exposure, suicide/homicide/danger assessment and planning, and screening and brief intervention for alcohol.

Conditions

Depression; Anxiety; Posttraumatic Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Waitlist-Control

Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Common Elements Treatment Approach

Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.

Group Type: EXPERIMENTAL

Common Elements Treatment Approach

Intervention Type: BEHAVIORAL

CETA components include:

1. Engagement (encouraging participation)

2. Psychoeducation (introduction)

3. Anxiety Management Strategies (relaxation)

4. Behavioral Activation (getting active)

5. Cognitive Coping/Restructuring (thinking in a different way, part I and part II)

6. Imaginal Gradual Exposure (talking about difficult memories)

7. In Vivo Exposure (Live exposure)

8. Suicide/Homicide/Danger Assessment and Planning (safety)

9. Screening and Brief Intervention for Alcohol (alcohol intervention)

Interventions

Common Elements Treatment Approach

CETA components include:

1. Engagement (encouraging participation)

2. Psychoeducation (introduction)

3. Anxiety Management Strategies (relaxation)

4. Behavioral Activation (getting active)

5. Cognitive Coping/Restructuring (thinking in a different way, part I and part II)

6. Imaginal Gradual Exposure (talking about difficult memories)

7. In Vivo Exposure (Live exposure)

8. Suicide/Homicide/Danger Assessment and Planning (safety)

9. Screening and Brief Intervention for Alcohol (alcohol intervention)

Intervention Type: BEHAVIORAL

Other Intervention Names

CETA

Eligibility Criteria

Inclusion Criteria

• Burmese national, 18 or over, living in Thailand outside of refugee camps, meets or exceed the algorithm for the Hopkins Symptoms Checklist 25 (HSCL-25) depression subscale and/or the algorithm for the Harvard Trauma Questionnaire (HTQ) posttraumatic stress scale.

Exclusion Criteria

• not Burmese national, under 18, not living in Thailand outside of refugee camps, does not meet meet or exceed the algorithm for the Hopkins Symptoms Checklist 25 (HSCL-25) depression subscale and/or the algorithm for the Harvard Trauma Questionnaire (HTQ) posttraumatic stress scale; active psychosis

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

Sponsors

Burma Border Projects

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Courtland Robinson, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Assistance Association for Political Prisoners; Mae Tao Clinic; Social Action for Women

Mae Sot, Changwat Tak, Thailand

Countries

Thailand

References

Bolton P, Lee C, Haroz EE, Murray L, Dorsey S, Robinson C, Ugueto AM, Bass J. A transdiagnostic community-based mental health treatment for comorbid disorders: development and outcomes of a randomized controlled trial among Burmese refugees in Thailand. PLoS Med. 2014 Nov 11;11(11):e1001757. doi: 10.1371/journal.pmed.1001757. eCollection 2014 Nov.

Reference Type: DERIVED

PMID: 25386945 (View on PubMed)

Other Identifiers

DFD-A-00-08-00308-0

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00003601

Identifier Type: -

Identifier Source: org_study_id