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Clinical Trials/NCT01624935
NCT01624935
Completed
N/A

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

University of California, San Francisco1 site in 1 country60 target enrollmentJuly 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Posttraumatic Stress Disorder
Sponsor
University of California, San Francisco
Enrollment
60
Locations
1
Primary Endpoint
Clinician Administered PTSD Scale (CAPS)
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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

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

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
April 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Clinician Administered PTSD Scale (CAPS)

Time Frame: baseline through week 24

CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24

Secondary Outcomes

  • Standard Clinical Interview for DSM IV Diagnosis (SCID)(baseline through week 24)

Study Sites (1)

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