Mental Health Assessment Project on the Thailand-Burma Border

Depression Clinical Trial

— MHAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459068
• Other study ID #: IRB00003601
• Secondary ID: DFD-A-00-08-0030
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: November 2012

Study information

• Verified date: October 2023
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Posttraumatic Stress

Intervention

Behavioral:
• Common Elements Treatment Approach
CETA components include: Engagement (encouraging participation) Psychoeducation (introduction) Anxiety Management Strategies (relaxation) Behavioral Activation (getting active) Cognitive Coping/Restructuring (thinking in a different way, part I and part II) Imaginal Gradual Exposure (talking about difficult memories) In Vivo Exposure (Live exposure) Suicide/Homicide/Danger Assessment and Planning (safety) Screening and Brief Intervention for Alcohol (alcohol intervention)

Locations

Country	Name	City	State
Thailand	Assistance Association for Political Prisoners; Mae Tao Clinic; Social Action for Women	Mae Sot	Tak Province

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Burma Border Projects

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Functional Impairment	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	10-16 weeks
Secondary	Anxiety Symptoms	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	10-16 weeks
Secondary	Aggression Behaviors	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	10-16 weeks
Secondary	Alcohol Use	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).	10-16 weeks