Mental Health Assessment Project on the Thailand-Burma Border

NCT01459068 | Completed Results

• 2 other identifiers: IRB00003601DFD-A-00-08-00308-0
• Study Type: interventional
• Target: 347
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Posttraumatic Stress

Outcome Measures

Primary Outcomes (2)

• Depression

  Depression symptoms were measured using a modified, locally validated version of the 15-item Hopkins Symptoms Checklist (HSCL-25) depression subscale. Respondents reported symptom frequency in the last month (0 "None of the time" to 3 "Almost always"). An algorithm was applied to the HSCL-25 to determine eligibility on the basis of moderate to severe depression. The HSCL-25 was also used to measure the depression severity outcome: Scores on the depression scale were calculated as average symptom scores across the 17 items and therefore ranged from 0-3

  10-16 weeks

• Posttraumatic Stress Symptoms

  Posttraumatic stress symptoms (PTSS) were measured using the 30-symptom items of the Harvard Trauma Questionnaire (HTQ). Response options were the same as the HSCL-25. An algorithm was applied to the HTQ to determine eligibility on the basis of moderate to severe PTSS. The HTQ was also used to measure the PTSS severity outcome: Scores for PTSS were calculated as average symptom scores across the 30 items. PTSS scores ranged from 0 (best possible outcome) to 3 (worst possible outcome).

  10-16 weeks

Secondary Outcomes (4)

• Functional Impairment

  10-16 weeks

• Anxiety Symptoms

  10-16 weeks

• Aggression Behaviors

  10-16 weeks

• Alcohol Use

  10-16 weeks

Study Arms (2)

Waitlist-Control

NO INTERVENTION

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.

Common Elements Treatment Approach

EXPERIMENTAL

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.

Behavioral: Common Elements Treatment Approach

Interventions

Common Elements Treatment Approach 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)

Also known as: CETA

Common Elements Treatment Approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Burma Border Projects: collaborator

Study Sites (1)

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

Mae Sot, Changwat Tak, Thailand

Location

Related Publications (1)

• 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.

  PMID: 25386945 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Courtland Robinson
• Organization: Johns Hopkins Bloomberg School of Public Health

crobinso@jhsph.edu

4104155266

Study Officials

• Courtland Robinson, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: October 25, 2011
• Study Start: August 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 4, 2023
• Results First Posted: June 6, 2014

Record last verified: 2023-10

Locations

TH (1)