Clinical trial NCT01624935: 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
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Depression
Keywords: PTSD
earthquake
disaster
global mental health
disaster mental health
depression
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: baseline through week 24
Secondary outcomes:
measure: Standard Clinical Interview for DSM IV Diagnosis (SCID)
timeFrame: baseline through week 24
Other outcomes:
Locations:
city: Shifang
country: China
facility: Wuhan Hospital for Psychotherapy
state: Sichuan
Study officials:
affiliation: University of California, San Francisco
name: Susan Meffert, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.