Study of Effectiveness of Mental Health Interventions Among Torture Survivors on the Thailand-Burma Border (MHAP)

This study is enrolling participants by invitation only.
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: NA
Last verified: October 2011
History: No changes posted
  Purpose

The aim of the study is to determine the effectiveness of a psychotherapeutic intervention - namely, Components-Based Intervention (CBI) - 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
Trauma
Behavioral: Components-Based Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group 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 symptomology [ Time Frame: 10-12 weeks ] [ Designated as safety issue: No ]
    Depression symptoms will be measured using a modified, locally validated version of the Hopkins Symptoms Checklist (HSCL. At the end of the intervention, the case group and the wait-control group will be re-interviewed. The mean change in the various subscales between pre and post intervention interviews will be calculated and subtracted from the mean change for the wait-control group.


Secondary Outcome Measures:
  • trauma symptomology [ Time Frame: 10-12 weeks ] [ Designated as safety issue: No ]
    Trauma exposure and symptoms will be measured using a modified, locally validated version of the Harvard Trauma Questionnaire (HTQ). At the end of the intervention, the case group and the wait-control group will be reinterviewed. The mean change in the various subscales between pre and post intervention interviews will be calculated and subtracted from the mean change for the wait-control group.


Estimated Enrollment: 300
Study Start Date: September 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Wait-Control
Measures of trauma or depression symptoms will be based on the responses to all trauma and depression questions in the screening interview. If this meets or exceeds a cutoff score of 45 for trauma and/or a cutoff score for depression of 13 or more then the person will be invited to join the trial after having been read a consent form. They will then be randomized into the wait-control arm.
Behavioral: Components-Based Intervention

CBI components include:

  1. Pre-Treatment: consent, intake/screening, & assessment
  2. Encouraging Participation
  3. Psychoeducation
  4. Behavioral Coping Skills
  5. Behavioral Coping Skills: Behavioral Activation
  6. Cognitive Coping:
  7. Gradual Exposure for Trauma
  8. Live Exposure for Fear-based Anxiety
  9. Cognitive Reprocessing
  10. Enhancing Safety
Other Name: Components Based Intervention

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 Project (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 Components-Based Intervention includes psycho-education, relaxation, life-enhancing skills (problems solving and safety planning), family support, and cognitive processing of life problems and traumatic events. The CBI model is being tested in a JHU study in Southern Iraq and preliminary results suggest that it may be effective for the population of displaced Burmese in Thailand. The duration of sessions is one hour, the frequency of treatment is weekly, and the recommended number of sessions in the Thailand/Burma border site is 10.

  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, meet or exceed cutoff score of 45 for trauma and/or a cutoff score of 13 or more for depression

Exclusion Criteria:

  • not Burmese national, under 18, not living in Thailand outside of refugee camps, do not meet cutoff score of 45 or more for trauma and/or a cutoff score of 13 or more for depression
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01459068

Locations
Thailand
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, 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
Last Updated: October 21, 2011
Health Authority: Thailand: Community Consultation Team

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on May 21, 2013