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Mental Health Assessment Project on the Thailand-Burma Border (MHAP)

This study has been completed.
Sponsor:
Collaborator:
Burma Border Projects
Information provided by (Responsible Party):
Courtland Robinson, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01459068
First received: October 21, 2011
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Depression
Anxiety
Posttraumatic Stress
Behavioral: Common Elements Treatment Approach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Effectiveness of Mental Health Interventions Among Torture Survivors on the Thailand-Burma Border

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Depression [ Time Frame: 10-16 weeks ] [ Designated as safety issue: No ]
    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

  • Posttraumatic Stress Symptoms [ Time Frame: 10-16 weeks ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Functional Impairment [ Time Frame: 10-16 weeks ] [ Designated as safety issue: No ]
    Functional impairment was measured using locally-developed, gender-specific scales. The scales contained 16 and 23 tasks for men and women, respectively. Respondents reported current difficulty compared to others of same gender and similar age (from 0 "No difficulty" to 4 "Often cannot do"). Scores were calculated as average task scores across the 16- and 23-item scales and therefore ranged from 0-4

  • Anxiety Symptoms [ Time Frame: 10-16 weeks ] [ Designated as safety issue: No ]
    Anxiety symptoms were measured using the 10-item HSCL-25 anxiety subscale with local adaptations. Respondent instructions and response categories were the same as the HSCL-25 depression subscale. Scores were calculated as average symptom scores across the 11-item scale and therefore ranged from 0-4

  • Aggression Behaviors [ Time Frame: 10-16 weeks ] [ Designated as safety issue: No ]
    The 12-item Aggression Questionnaire (AQ) was adapted for local use. Respondents rated frequency in general of aggressive behaviors from 0 "None of the time" to 4 "Almost all of the time." Scores were calculated as averages scores for each behavior across the 12-item scale and therefore ranged from 0-4

  • Alcohol Use [ Time Frame: 10-16 weeks ] [ Designated as safety issue: No ]
    Alcohol use was measured using the Alcohol Use Disorders Identification Test (AUDIT). Respondents reported frequency and amount of alcohol consumed, referencing photographs of local alcohols (local beers, rice whiskeys, etc.). Total scores were calculated as sum totals across the 10-item scale. AUDIT total scores ranged from 0 (best possible outcome) to 40 (worst possible outcome).


Enrollment: 347
Study Start Date: August 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.
Experimental: 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.
Behavioral: 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)
Other Name: CETA

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459068

Locations
Thailand
Assistance Association for Political Prisoners; Mae Tao Clinic; Social Action for Women
Mae Sot, Tak Province, Thailand
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Burma Border Projects
Investigators
Principal Investigator: Courtland Robinson, PhD Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided

Responsible Party: Courtland Robinson, Associate Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01459068     History of Changes
Other Study ID Numbers: IRB00003601, DFD-A-00-08-00308-0
Study First Received: October 21, 2011
Results First Received: April 16, 2014
Last Updated: May 19, 2014
Health Authority: Thailand: Community Consultation Team

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 24, 2014