Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake

Study Overview
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Brief Summary
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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.

Detailed Description
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Interpersonal Psychotherapy adapted for local mental health care needs was applied using wait list control design.

Official Title
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Randomized Controlled Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake

Conditions
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Posttraumatic Stress Disorder, Depression

Intervention / Treatment
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* Behavioral: interpersonal psychotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: psychotherapy<br>psychotherapy | Behavioral: interpersonal psychotherapy<br>* interpersonal psychotherapy<br>|
| Other: treatment as usual<br>TAU control | Behavioral: interpersonal psychotherapy<br>* interpersonal psychotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale (CAPS) | CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24 | baseline through week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard Clinical Interview for DSM IV Diagnosis (SCID) | CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24 | baseline through week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, earthquake, disaster, global mental health, disaster mental health, depression