Mental Health Assessment Project on the Thailand-Burma Border (MHAP)
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| ClinicalTrials.gov Identifier: NCT01459068 |
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Recruitment Status :
Completed
First Posted : October 25, 2011
Results First Posted : June 6, 2014
Last Update Posted : June 6, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Depression Anxiety Posttraumatic Stress | Behavioral: Common Elements Treatment Approach | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 347 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Study of Effectiveness of Mental Health Interventions Among Torture Survivors on the Thailand-Burma Border |
| Study Start Date : | August 2011 |
| Actual Primary Completion Date : | November 2012 |
| Actual Study Completion Date : | November 2012 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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.
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Behavioral: Common Elements Treatment Approach
CETA components include:
Other Name: CETA |
- Depression [ Time Frame: 10-16 weeks ]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 ]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).
- Functional Impairment [ Time Frame: 10-16 weeks ]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 ]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 ]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 ]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).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459068
| Thailand | |
| Assistance Association for Political Prisoners; Mae Tao Clinic; Social Action for Women | |
| Mae Sot, Tak Province, Thailand | |
| Principal Investigator: | Courtland Robinson, PhD | Johns Hopkins Bloomberg School of Public Health |
| Responsible Party: | Courtland Robinson, Associate Professor, Johns Hopkins Bloomberg School of Public Health |
| ClinicalTrials.gov Identifier: | NCT01459068 |
| Other Study ID Numbers: |
IRB00003601 DFD-A-00-08-00308-0 ( Other Identifier: USAID ) |
| First Posted: | October 25, 2011 Key Record Dates |
| Results First Posted: | June 6, 2014 |
| Last Update Posted: | June 6, 2014 |
| Last Verified: | May 2014 |
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Depression Behavioral Symptoms |