Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake
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Purpose
The enormous global burden of mental illness has been estimated through the publication of the Global Burden of Disease Study. Research confirms that populations exposed to mass trauma such as natural disaster bear a particularly high burden of mental disorders, with depression and Posttraumatic Stress Disorder (PTSD) generally being the top two adult psychiatric diagnoses. In traumatized populations, these disorders do not remit with replacement of material losses or resettlement to safe locations, but rather tend to become chronic conditions with attendant disability. 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. This "infectious" model of trauma/violence is critically important in the setting of natural disaster, as increased levels of interpersonal violence within the afflicted community hinder its recovery. To date, there has been little research on the interpersonal effects of mass trauma. The proposed research is a randomized controlled trial of "Interpersonal Therapy" (IPT) versus wait list control (WLC) for survivors of the Sichuan Earthquake living in Shifang, China. IPT, a very effective therapy for depression, has been adapted for PTSD treatment and developing country settings. Measures will evaluate success of the treatment not only in terms of individual depression and PTSD symptoms, but also with respect to interpersonal functioning.
Hypothesis 1: Relative to wait list control, fewer subjects who received IPT will meet criteria for Depression and PTSD at the conclusion of the RCT.
Hypothesis 2: Subjects who received IPT will have greater improvement of social functioning than wait list controls.
| Condition | Intervention |
|---|---|
|
Posttraumatic Stress Disorder Depression |
Behavioral: interpersonal psychotherapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Controlled Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake |
- Clinician Administered PTSD Scale (CAPS) [ Time Frame: baseline through week 24 ] [ Designated as safety issue: No ]CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24
- Standard Clinical Interview for DSM IV Diagnosis (SCID) [ Time Frame: baseline through week 24 ] [ Designated as safety issue: No ]CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24
| Enrollment: | 60 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: psychotherapy
psychotherapy
|
Behavioral: interpersonal psychotherapy
interpersonal psychotherapy
|
|
No Intervention: wait list control
wait list control
|
Behavioral: interpersonal psychotherapy
interpersonal psychotherapy
|
Detailed Description:
Interpersonal Psychotherapy adapted for local mental health care needs was applied using wait list control design.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age greater than 18 years;
- diagnosis with Depressive Disorder and Posttraumatic Stress Disorder (PTSD);
- Ability to attend weekly therapy sessions for 12 weeks and return for post-treatment screening;
- Ability to give verbal informed consent
Exclusion Criteria:
- 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 and alcohol dependence
Contacts and Locations| China, Sichuan | |
| Wuhan Hospital for Psychotherapy | |
| Shifang, Sichuan, China | |
| Principal Investigator: | Susan Meffert, MD, MPH | University of California, San Francisco |
More Information
No publications provided
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01624935 History of Changes |
| Other Study ID Numbers: | 10-02408 |
| Study First Received: | February 7, 2012 |
| Last Updated: | June 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, San Francisco:
|
PTSD earthquake disaster |
global mental health disaster mental health depression |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic |
Behavioral Symptoms Mood Disorders Mental Disorders Anxiety Disorders |
ClinicalTrials.gov processed this record on June 17, 2013