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Completed

NCT Number: NCT01177072

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

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. 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.

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Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Post-traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ministry of Health Iraq

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Exposure to Torture
  • PTSD

Exclusion criteria

  • Children
  • Mentally incompetent to understand therapy

Treatment and study plan

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.

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.

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.

    Time frame: After 12 counseling , 4-5 months

    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 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).

    Time frame: After 12 counseling session, estimated 4-5 months.

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Heartland Alliance
  • Ministry of Health, Iraq
  • United States Agency for International Development (USAID)

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 6, 2010
Registry last updated
May 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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