Mental Health Assessment Project (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: April 10, 2014
Last verified: April 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
Trauma
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 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.


Enrollment: 347
Study Start Date: September 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Wait-Control
Eligible study subjects assigned to the wait-control group were monitored regularly while being asked to wait until the intervention was completed for the group receiving the CETA intervention, after which time they were offered CETA counseling if they wished.
Experimental: CETA
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
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
Last Updated: April 10, 2014
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 April 17, 2014