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Study of Effectiveness of Mental Health Interventions Among Torture Survivors in Southern Iraq

Primary Purpose

Depression, Anxiety, Post-Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Cognitive Processing Therapy
Components-Based Intervention
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring PTSD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Exposure to Torture
  • PTSD

Exclusion Criteria:

  • Children
  • Mentally incompetent to understand therapy

Sites / Locations

  • Ministry of Health Iraq

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Components-Based Interventions (CBI)

Cognitive Processing Therapy

Wait List Control

Arm Description

12 sessions of cognitive processing therapy. Sessions are expected to be approximately one week apart. Although each counseling session is designed to be carried out one week apart for a total of 12 weeks, there are many reasons why a session will be missed. Our estimation is that a single client will require 4-5 months to complete the therapy.

12 sessions of cognitive processing therapy. Sessions are expected to be approximately one week apart. Although each counseling session is designed to be carried out one week apart for a total of 12 weeks, there are many reasons why a session will be missed. Our estimation is that a single client will require 4-5 months to complete the therapy.

Eligible clients will not be provided therapy at enrollment. After the study period has completed, control clients will be re-interviewed. Those that remain eligible due to symptom cutoff scores will be offered therapy. In the interim, controls will receive a phone call once a month; those with indications of possible harm to self or others will be referred to a psychiatrist.

Outcomes

Primary Outcome Measures

Severity of Trauma. This will be the difference in group mean score of severity of depression based on a sum of ratings of various standard depression symptoms from the Hopkins Symptom Checklist and locally defined symptoms.
Although each counseling session is designed to be carried out one week apart for a total of 12 weeks, there are many reasons why a session will be missed. Our estimation is that a single client will require 4-5 months to complete the therapy.

Secondary Outcome Measures

Ability to Function. This is the difference in group mean of ability to function based on the sum of ratings of functional ability among various tasks identified by the local population as important functions (men and women have separate tasks).
Although each counseling session is designed to be carried out one week apart for a total of 12 weeks, there are many reasons why a session will be missed. Our estimation is that a single client will require 4-5 months to complete the therapy.

Full Information

First Posted
July 16, 2010
Last Updated
May 1, 2013
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Heartland Alliance, Ministry of Health, Iraq, United States Agency for International Development (USAID)
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1. Study Identification

Unique Protocol Identification Number
NCT01177072
Brief Title
Study of Effectiveness of Mental Health Interventions Among Torture Survivors in Southern Iraq
Official Title
Study of Effectiveness of Mental Health Interventions Among Torture Survivors in Southern Iraq
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Heartland Alliance, Ministry of Health, Iraq, United States Agency for International Development (USAID)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
That the psychotherapeutic intervention - Components-Base Interventions (CBI) - is effective in reducing the severity of mental health symptoms experienced by torture survivors in Southern Iraq. That the psychotherapeutic intervention - Cognitive Processing Therapy (CPT) - is effective in reducing the severity of mental health symptoms experienced by torture survivors in Southern Iraq.
Detailed Description
For each intervention, participants will undergo 12 sessions (CBI or CPT) that are standardized by training and manual for community mental health workers (CHMWs). CMHWs will be trained in only one intervention. Prior to the starting sessions, a baseline assessment of depression, anxiety and trauma symptoms and function will be carried out. A follow up assessment will be carried out after the 12 sessions have been completed. Expected time between sessions is one week. The total time per client is expected to last about 4-5 months to complete the 12 therapy sessions. Participants will be randomized (within CMHW) to either immediate intervention or wait-list control. Participants that are wait-list control will be contacted monthly for assessment of condition. Any participant (intervention or control) with suicidal thoughts or distress that does not abate will be referred for psychiatric care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Post-Traumatic Stress Disorder
Keywords
PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
342 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Components-Based Interventions (CBI)
Arm Type
Experimental
Arm Description
12 sessions of cognitive processing therapy. Sessions are expected to be approximately one week apart. Although each counseling session is designed to be carried out one week apart for a total of 12 weeks, there are many reasons why a session will be missed. Our estimation is that a single client will require 4-5 months to complete the therapy.
Arm Title
Cognitive Processing Therapy
Arm Type
Experimental
Arm Description
12 sessions of cognitive processing therapy. Sessions are expected to be approximately one week apart. Although each counseling session is designed to be carried out one week apart for a total of 12 weeks, there are many reasons why a session will be missed. Our estimation is that a single client will require 4-5 months to complete the therapy.
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
Eligible clients will not be provided therapy at enrollment. After the study period has completed, control clients will be re-interviewed. Those that remain eligible due to symptom cutoff scores will be offered therapy. In the interim, controls will receive a phone call once a month; those with indications of possible harm to self or others will be referred to a psychiatrist.
Intervention Type
Other
Intervention Name(s)
Cognitive Processing Therapy
Intervention Description
12 sessions of cognitive processing therapy. Sessions are expected to be approximately one week apart. Although each counseling session is designed to be carried out one week apart for a total of 12 weeks, there are many reasons why a session will be missed. Our estimation is that a single client will require 4-5 months to complete the therapy.
Intervention Type
Other
Intervention Name(s)
Components-Based Intervention
Intervention Description
This is a 'components-based' intervention include psychoeducation, relaxation, life-enhancing skills (problems solving and safety planning), exposure, and cognitive processing of life problems and traumatic events. The duration of sessions are approximately one hour), the expected frequency of treatment is weekly, and recommended number of sessions are 12.
Primary Outcome Measure Information:
Title
Severity of Trauma. This will be the difference in group mean score of severity of depression based on a sum of ratings of various standard depression symptoms from the Hopkins Symptom Checklist and locally defined symptoms.
Description
Although each counseling session is designed to be carried out one week apart for a total of 12 weeks, there are many reasons why a session will be missed. Our estimation is that a single client will require 4-5 months to complete the therapy.
Time Frame
After 12 counseling , 4-5 months
Secondary Outcome Measure Information:
Title
Ability to Function. This is the difference in group mean of ability to function based on the sum of ratings of functional ability among various tasks identified by the local population as important functions (men and women have separate tasks).
Description
Although each counseling session is designed to be carried out one week apart for a total of 12 weeks, there are many reasons why a session will be missed. Our estimation is that a single client will require 4-5 months to complete the therapy.
Time Frame
After 12 counseling session, estimated 4-5 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Exposure to Torture PTSD Exclusion Criteria: Children Mentally incompetent to understand therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William M Weiss, DrPH
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ministry of Health Iraq
City
Several cities in Iraq (Karbala, Basra, Najaf, etc.)
Country
Iraq

12. IPD Sharing Statement

Citations:
PubMed Identifier
26467303
Citation
Weiss WM, Murray LK, Zangana GA, Mahmooth Z, Kaysen D, Dorsey S, Lindgren K, Gross A, Murray SM, Bass JK, Bolton P. Community-based mental health treatments for survivors of torture and militant attacks in Southern Iraq: a randomized control trial. BMC Psychiatry. 2015 Oct 14;15:249. doi: 10.1186/s12888-015-0622-7.
Results Reference
derived

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Study of Effectiveness of Mental Health Interventions Among Torture Survivors in Southern Iraq

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