Trial Outcomes & Findings for Mental Health Assessment Project on the Thailand-Burma Border (NCT NCT01459068)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

347 participants

Primary outcome timeframe

10-16 weeks

Results posted on

2023-10-04

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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)
Overall Study STARTED	165	182
Overall Study COMPLETED	126	148
Overall Study NOT COMPLETED	39	34

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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)
Overall Study Withdrawal by Subject	8	18
Overall Study Lost to Follow-up	31	15
Overall Study Death	0	1

Baseline Characteristics

Mental Health Assessment Project on the Thailand-Burma Border

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Waitlist-Control n=165 Participants 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 n=182 Participants 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)	Total n=347 Participants Total of all reporting groups
Age, Continuous	34.3 years STANDARD_DEVIATION 11.4 • n=5 Participants	36.5 years STANDARD_DEVIATION 12.6 • n=7 Participants	35.4 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	106 Participants n=5 Participants	111 Participants n=7 Participants	217 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	71 Participants n=7 Participants	130 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Waitlist-Control n=165 Participants 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 n=182 Participants 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)
Depression	-0.52 units on a scale Standard Error .06	-1.02 units on a scale Standard Error .05

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Waitlist-Control n=165 Participants 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 n=182 Participants 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)
Posttraumatic Stress Symptoms	-0.38 units on a scale Standard Error .05	-0.80 units on a scale Standard Error .04

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Waitlist-Control n=165 Participants 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 n=182 Participants 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)
Functional Impairment	-0.20 units on a scale Standard Error .09	-0.64 units on a scale Standard Error .10

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Waitlist-Control n=165 Participants 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 n=182 Participants 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)
Anxiety Symptoms	-0.42 units on a scale Standard Error 0.09	-0.90 units on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Waitlist-Control n=165 Participants 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 n=182 Participants 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)
Aggression Behaviors	-0.22 units on a scale Standard Error 0.05	-0.47 units on a scale Standard Error 0.03

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Waitlist-Control n=15 Participants 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 n=18 Participants 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)
Alcohol Use	-1.29 units on a scale Standard Error 0.21	-1.25 units on a scale Standard Error 0.17

Adverse Events

Waitlist-Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Common Elements Treatment Approach

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Courtland Robinson

Johns Hopkins Bloomberg School of Public Health

Phone: 4104155266

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place