Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake
Primary Purpose
Posttraumatic Stress Disorder, Depression
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
interpersonal psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, earthquake, disaster, global mental health, disaster mental health, depression
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
Sites / Locations
- Wuhan Hospital for Psychotherapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
psychotherapy
treatment as usual
Arm Description
psychotherapy
TAU control
Outcomes
Primary Outcome Measures
Clinician Administered PTSD Scale (CAPS)
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)
CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24
Full Information
NCT ID
NCT01624935
First Posted
February 7, 2012
Last Updated
September 30, 2013
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT01624935
Brief Title
Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake
Official Title
Randomized Controlled Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Depression
Keywords
PTSD, earthquake, disaster, global mental health, disaster mental health, depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
psychotherapy
Arm Type
Experimental
Arm Description
psychotherapy
Arm Title
treatment as usual
Arm Type
Other
Arm Description
TAU control
Intervention Type
Behavioral
Intervention Name(s)
interpersonal psychotherapy
Intervention Description
interpersonal psychotherapy
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS)
Description
CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24
Time Frame
baseline through week 24
Secondary Outcome Measure Information:
Title
Standard Clinical Interview for DSM IV Diagnosis (SCID)
Description
CAPS and SCID assessed before and after treatment after tx conclusion at week 0, week 12, week 24
Time Frame
baseline through week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Meffert, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wuhan Hospital for Psychotherapy
City
Shifang
State/Province
Sichuan
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
25254070
Citation
Jiang RF, Tong HQ, Delucchi KL, Neylan TC, Shi Q, Meffert SM. Interpersonal psychotherapy versus treatment as usual for PTSD and depression among Sichuan earthquake survivors: a randomized clinical trial. Confl Health. 2014 Sep 4;8:14. doi: 10.1186/1752-1505-8-14. eCollection 2014.
Results Reference
derived
Learn more about this trial
Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake
We'll reach out to this number within 24 hrs