NCT00879853

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2009

Completed
Last Updated

November 8, 2023

Status Verified

November 1, 2023

First QC Date

April 9, 2009

Last Update Submit

November 6, 2023

Conditions

Keywords

PTSDDepressionAngerDomestic ViolenceRefugeeAsylum SeekerCommunity TherapistParaprofessional Therapists

Outcome Measures

Primary Outcomes (1)

  • Post-traumatic Stress Disorder Symptoms

Secondary Outcomes (3)

  • Depression Symptoms

  • Anger

  • Household Conflict/Violence

Study Arms (2)

Interpersonal Therapy

EXPERIMENTAL
Behavioral: Interpersonal Therapy

Wait List Control

NO INTERVENTION

Interventions

Interpersonal Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ma'an Organization

Cairo, Egypt

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepression

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 9, 2009

First Posted

April 13, 2009

Last Updated

November 8, 2023

Record last verified: 2023-11

Locations