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Completed

NCT Number: NCT00879853

Trial of Mental Health Treatment for Darfur Refugees in Cairo

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ma'an Organization

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

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 .

Treatment and study plan

Interpersonal Therapy

Behavioral

Primary outcomes

  1. Post-traumatic Stress Disorder Symptoms

Secondary outcomes

  1. Depression Symptoms

  2. Anger

  3. Household Conflict/Violence

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Ma'an Organization

Registry information

Official study title

Randomized Controlled Trial of Mental Health Treatment for Darfur Refugees in Cairo

Important dates

First posted
Apr 13, 2009
Registry last updated
Nov 8, 2023

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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