Post-Traumatic Stress DisorderNCT00879853
Trial of Mental Health Treatment for Darfur Refugees in Cairo
A study testing Interpersonal Therapy in people with Post-Traumatic Stress Disorder and Depression, run by University of California, San Francisco at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder, Depression, Anger
- What is being tested?
- Interpersonal Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteEgypt
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled 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.
- Conditions
- Post-Traumatic Stress Disorder, Depression, Anger, Domestic Violence
- Being tested
- Interpersonal Therapy
- Keywords
- PTSD, Depression, Anger, Domestic Violence, Refugee, Asylum Seeker, Community Therapist, Paraprofessional Therapists
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpersonal TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal Therapy | Experimental | Not described Receives: Behavioral: Interpersonal Therapy |
| Wait List Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-traumatic Stress Disorder Symptoms
Secondary outcomes (3)
Depression Symptoms
Anger
Household Conflict/Violence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Ma'an Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879853
- Sponsor's protocol ID
- UCSF Academic Senate Grant
- Status last verified
- Nov 2023
- First submitted
- 9 Apr 2009
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Mental Health Treatment for Darfur Refugees in Cairo
- ClinicalTrials.gov ID
- NCT00879853
- Acronym / sponsor ID
- UCSF Academic Senate Grant
- Conditions
- Post-Traumatic Stress Disorder, Depression, Anger, Domestic Violence
- Keywords
- PTSD, Depression, Anger, Domestic Violence, Refugee, Asylum Seeker, Community Therapist, Paraprofessional Therapists
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Ma'an Organization
- First posted
- 13 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Therapy | Experimental | Behavioral: Interpersonal Therapy |
| Wait List Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpersonal Therapy | Behavioural | Interpersonal Therapy |
Primary outcome
Post-traumatic Stress Disorder Symptoms
3 secondary outcomes
Depression Symptoms
Anger
Household Conflict/Violence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Therapy in people with Post-Traumatic Stress Disorder and Depression, run by University of California, San Francisco at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-traumatic Stress Disorder Symptoms. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.