Mental Health Assessment Project on the Thailand-Burma Border (MHAP)

This study has been completed.
Sponsor:
Collaborator:
Burma Border Projects
Information provided by (Responsible Party):
Courtland Robinson, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01459068
First received: October 21, 2011
Last updated: May 19, 2014
Last verified: May 2014
Results First Received: April 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depression
Anxiety
Posttraumatic Stress
Intervention: Behavioral: Common Elements Treatment Approach

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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)

Participant Flow:   Overall Study
    Waitlist-Control     Common Elements Treatment Approach  
STARTED     165     182  
COMPLETED     126     148  
NOT COMPLETED     39     34  
Withdrawal by Subject                 8                 18  
Lost to Follow-up                 31                 15  
Death                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
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)
Total Total of all reporting groups

Baseline Measures
    Waitlist-Control     Common Elements Treatment Approach     Total  
Number of Participants  
[units: participants]
  165     182     347  
Age  
[units: years]
Mean ± Standard Deviation
  34.3  ± 11.4     36.5  ± 12.6     35.4  ± 12.1  
Gender  
[units: participants]
     
Female     106     111     217  
Male     59     71     130  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Depression   [ Time Frame: 10-16 weeks ]

2.  Primary:   Posttraumatic Stress Symptoms   [ Time Frame: 10-16 weeks ]

3.  Secondary:   Functional Impairment   [ Time Frame: 10-16 weeks ]

4.  Secondary:   Anxiety Symptoms   [ Time Frame: 10-16 weeks ]

5.  Secondary:   Aggression Behaviors   [ Time Frame: 10-16 weeks ]

6.  Secondary:   Alcohol Use   [ Time Frame: 10-16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Courtland Robinson
Organization: Johns Hopkins Bloomberg School of Public Health
phone: 4104155266
e-mail: crobinso@jhsph.edu


No publications provided


Responsible Party: Courtland Robinson, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01459068     History of Changes
Other Study ID Numbers: IRB00003601, DFD-A-00-08-00308-0
Study First Received: October 21, 2011
Results First Received: April 16, 2014
Last Updated: May 19, 2014
Health Authority: Thailand: Community Consultation Team