Depression, Anxiety, Posttraumatic Stress
Conditions
Brief 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.
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.
Interventions
BEHAVIORALCommon 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)
Sponsors
Burma Border Projects
Johns Hopkins Bloomberg School of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Impairment | 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 | 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 | 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 | 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). |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 165 |
| 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:
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) | 182 |
| Total | 347 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 31 | 15 |
| Overall Study | Withdrawal by Subject | 8 | 18 |
Baseline characteristics
| Characteristic | Waitlist-Control | Common Elements Treatment Approach | Total |
|---|---|---|---|
| Age, Continuous | 34.3 years STANDARD_DEVIATION 11.4 | 36.5 years STANDARD_DEVIATION 12.6 | 35.4 years STANDARD_DEVIATION 12.1 |
| Sex: Female, Male Female | 106 Participants | 111 Participants | 217 Participants |
| Sex: Female, Male Male | 59 Participants | 71 Participants | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 165 | 0 / 182 |
| serious Total, serious adverse events | 0 / 165 | 0 / 182 |
Outcome results
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
Time frame: 10-16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist-Control | Depression | -0.52 units on a scale | Standard Error 0.06 |
| Common Elements Treatment Approach | Depression | -1.02 units on a scale | Standard Error 0.05 |
p-value: <0.00195% CI: [-0.59, -0.4]longitudinal model
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).
Time frame: 10-16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist-Control | Posttraumatic Stress Symptoms | -0.38 units on a scale | Standard Error 0.05 |
| Common Elements Treatment Approach | Posttraumatic Stress Symptoms | -0.80 units on a scale | Standard Error 0.04 |
p-value: <0.00195% CI: [-0.51, -0.35]longitudinal model
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
Time frame: 10-16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist-Control | Aggression Behaviors | -0.22 units on a scale | Standard Error 0.05 |
| Common Elements Treatment Approach | Aggression Behaviors | -0.47 units on a scale | Standard Error 0.03 |
p-value: <0.00195% CI: [-0.34, -0.15]longitudinal model
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).
Time frame: 10-16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist-Control | Alcohol Use | -1.29 units on a scale | Standard Error 0.21 |
| Common Elements Treatment Approach | Alcohol Use | -1.25 units on a scale | Standard Error 0.17 |
p-value: 0.89695% CI: [-0.44, 0.5]longitudinal model
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
Time frame: 10-16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist-Control | Anxiety Symptoms | -0.42 units on a scale | Standard Error 0.09 |
| Common Elements Treatment Approach | Anxiety Symptoms | -0.90 units on a scale | Standard Error 0.08 |
p-value: <0.00195% CI: [-0.61, -0.34]longitudinal model
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
Time frame: 10-16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Waitlist-Control | Functional Impairment | -0.20 units on a scale | Standard Error 0.09 |
| Common Elements Treatment Approach | Functional Impairment | -0.64 units on a scale | Standard Error 0.1 |
p-value: <0.00195% CI: [-0.59, -0.28]longitudinal model