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| ID | Type | Description | Link |
|---|---|---|---|
| DFD-A-00-08-00308-0 | Other Identifier | USAID |
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| Name | Class |
|---|---|
| Burma Border Projects | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Waitlist-Control | No Intervention | 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. | |
| Common Elements Treatment Approach | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Common Elements Treatment Approach | Behavioral | CETA components include:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Courtland Robinson, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Association for Political Prisoners; Mae Tao Clinic; Social Action for Women | Mae Sot | Changwat Tak | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25386945 | Derived | Bolton P, Lee C, Haroz EE, Murray L, Dorsey S, Robinson C, Ugueto AM, Bass J. A transdiagnostic community-based mental health treatment for comorbid disorders: development and outcomes of a randomized controlled trial among Burmese refugees in Thailand. PLoS Med. 2014 Nov 11;11(11):e1001757. doi: 10.1371/journal.pmed.1001757. eCollection 2014 Nov. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. Common Elements Treatment Approach: CETA components include:
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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We estimated 150 participants in each arm using the test for paired means, based on a moderate effect size (0.50), 80% power, two-tailed 5% significance level, design effect of 1.5, and up to a 50% expected drop-out rate (due to frequent cross-border movement).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Common Elements Treatment Approach |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Error | units on a scale | 10-16 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Courtland Robinson | Johns Hopkins Bloomberg School of Public Health | 4104155266 | crobinso@jhsph.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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|
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| 10-16 weeks |
| 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 |
| 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 |
| 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 |
| Death |
|
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. Common Elements Treatment Approach: CETA components include:
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| 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. Common Elements Treatment Approach: CETA components include:
|
|
|
|
| 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 | Posted | Mean | Standard Error | units on a scale | 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). | Posted | Mean | Standard Error | units on a scale | 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 | Posted | Mean | Standard Error | units on a scale | 10-16 weeks |
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|
|
|
| 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 | Posted | Mean | Standard Error | units on a scale | 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). | Posted | Mean | Standard Error | units on a scale | 10-16 weeks |
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|
| 0 |
| 165 |
| 0 |
| 165 |
| EG001 | 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. Common Elements Treatment Approach: CETA components include:
| 0 | 182 | 0 | 182 |
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