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Trial of Mental Health Treatment for Darfur Refugees in Cairo

Primary Purpose

Post-Traumatic Stress Disorder, Depression, Anger

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Interpersonal Therapy
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Post-Traumatic Stress Disorder focused on measuring PTSD, Depression, Anger, Domestic Violence, Refugee, Asylum Seeker, Community Therapist, Paraprofessional Therapists

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age greater than 18 years;
  2. Absence of cognitive dysfunction which requires a higher level of care and/or interferes with ability to participate in IPT;
  3. Absence of severe thought or mood disorder symptoms which requires a higher level of care and/or interferes with ability to participate in IPT;
  4. Absence of drug and alcohol dependence;
  5. HTQ score of 2.3 or greater;
  6. Ability to attend twice a week therapy sessions for 4 weeks and return for regular screening;
  7. Ability to give verbal informed consent .

Exclusion Criteria:

  1. Unable to give informed consent;
  2. Age less than 18;
  3. Cognitive dysfunction which requires a higher level of care and/or interferes with ability to participate in IPT;
  4. Severe thought or mood disorder symptoms which requires a higher level of care and/or interferes with ability to participate in IPT;
  5. Drug or alcohol dependence in the past 6 months;
  6. HTQ score less than 2.5;
  7. Inability to attend twice a week therapy sessions for 4 weeks and return for regular screening .

Sites / Locations

  • Ma'an Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interpersonal Therapy

Wait List Control

Arm Description

Outcomes

Primary Outcome Measures

Post-traumatic Stress Disorder Symptoms

Secondary Outcome Measures

Depression Symptoms
Anger
Household Conflict/Violence

Full Information

First Posted
April 9, 2009
Last Updated
April 10, 2009
Sponsor
University of California, San Francisco
Collaborators
Ma'an Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00879853
Brief Title
Trial of Mental Health Treatment for Darfur Refugees in Cairo
Official Title
Randomized Controlled Trial of Mental Health Treatment for Darfur Refugees in Cairo
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco
Collaborators
Ma'an Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The enormous global burden of mental illness has been estimated through the publication of the Global Burden of Disease Study, adding momentum to refugee mental health studies (1,2). As research confirms that high levels of Posttraumatic Stress Disorder (PTSD) and depression occur in post-conflict settings, it is essential to develop effective treatment for psychological trauma in refugee populations recovering from mass violence (3-4). PTSD and depression are risk factors for anger, interpersonal discord and violence, not only among those who have trauma and depression, but also among their spouses and children (5-9). This "infectious" model of trauma/violence is critically important in the setting of ethnic conflict, as increased levels of interpersonal violence within the afflicted community hinder its recovery and fuel future cycles of conflict. To date, there has been little research on the interpersonal effects of trauma among refugee populations. The proposed research is a pilot and randomized controlled trial of "Interpersonal Therapy" (IPT) for Sudanese refugees living in Cairo. IPT, a very effective therapy for depression, has been adapted for PTSD treatment and sub-Saharan Africa settings (10-12). Measures will evaluate success of the treatment not only in terms of individual PTSD and depression symptoms, but also with respect to interpersonal conflict. Hypotheses: (1) After IPT intervention, Sudanese refugees will have lower levels of depression and trauma symptoms compared to wait list controls (2) After IPT intervention, Sudanese refugees will have lower levels of interpersonal violence compared to wait list controls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder, Depression, Anger, Domestic Violence
Keywords
PTSD, Depression, Anger, Domestic Violence, Refugee, Asylum Seeker, Community Therapist, Paraprofessional Therapists

7. Study Design

Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
Interpersonal Therapy
Arm Type
Experimental
Arm Title
Wait List Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Therapy
Primary Outcome Measure Information:
Title
Post-traumatic Stress Disorder Symptoms
Secondary Outcome Measure Information:
Title
Depression Symptoms
Title
Anger
Title
Household Conflict/Violence

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age greater than 18 years; Absence of cognitive dysfunction which requires a higher level of care and/or interferes with ability to participate in IPT; Absence of severe thought or mood disorder symptoms which requires a higher level of care and/or interferes with ability to participate in IPT; Absence of drug and alcohol dependence; HTQ score of 2.3 or greater; Ability to attend twice a week therapy sessions for 4 weeks and return for regular screening; Ability to give verbal informed consent . Exclusion Criteria: Unable to give informed consent; Age less than 18; Cognitive dysfunction which requires a higher level of care and/or interferes with ability to participate in IPT; Severe thought or mood disorder symptoms which requires a higher level of care and/or interferes with ability to participate in IPT; Drug or alcohol dependence in the past 6 months; HTQ score less than 2.5; Inability to attend twice a week therapy sessions for 4 weeks and return for regular screening .
Facility Information:
Facility Name
Ma'an Organization
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Trial of Mental Health Treatment for Darfur Refugees in Cairo

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