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

NCT01177072 | Completed

• 1 other identifier: JHSPH-3034
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.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.
2. 2.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.

Conditions

Depression; Anxiety; Post-Traumatic Stress Disorder

Keywords

PTSD

Outcome Measures

Primary Outcomes (1)

• 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.

  After 12 counseling , 4-5 months

Secondary Outcomes (1)

• 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).

  After 12 counseling session, estimated 4-5 months.

Study Arms (3)

Components-Based Interventions (CBI)

EXPERIMENTAL

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.

Other: Components-Based Intervention

Cognitive Processing Therapy

EXPERIMENTAL

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.

Other: Cognitive Processing Therapy

Wait List Control

NO INTERVENTION

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.

Interventions

Cognitive Processing Therapy OTHER

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.

Cognitive Processing Therapy

Components-Based Intervention OTHER

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.

Components-Based Interventions (CBI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Exposure to Torture
• PTSD

You may not qualify if:

• Children
• Mentally incompetent to understand therapy

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Heartland Alliance: collaborator
• Ministry of Health, Iraq: collaborator
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

Ministry of Health Iraq

Several Cities in Iraq (Karbala, Basra, Najaf, Etc.), Iraq

Location

Related Publications (1)

• 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.

  PMID: 26467303 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• William M Weiss, DrPH

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Scientist

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: August 6, 2010
• Study Start: March 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 3, 2013

Record last verified: 2013-05

Locations

IR (1)