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Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01624935
First Posted: June 21, 2012
Last Update Posted: October 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  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
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Standard Clinical Interview for DSM IV Diagnosis (SCID) [ Time Frame: baseline through week 24 ]
    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
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: psychotherapy
psychotherapy
Behavioral: interpersonal psychotherapy
interpersonal psychotherapy
treatment as usual
TAU 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01624935


Locations
China, Sichuan
Wuhan Hospital for Psychotherapy
Shifang, Sichuan, China
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Susan Meffert, MD, MPH University of California, San Francisco
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01624935     History of Changes
Other Study ID Numbers: 10-02408
First Submitted: February 7, 2012
First Posted: June 21, 2012
Last Update Posted: October 1, 2013
Last Verified: September 2013

Keywords provided by University of California, San Francisco:
PTSD
earthquake
disaster
global mental health
disaster mental health
depression

Additional relevant MeSH terms:
Depression
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders