Clinical trial NCT03803332: A Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Due to Military Sexual Trauma (MST) in Male and Female Military Personnel
Official title: A Non-Inferiority Randomized Controlled Clinical Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Consequent to Military Sexual Trauma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PTSD
Keywords: PTSD
Military Sexual Trauma
exposure therapy
interpersonal psychotherapy
treatment
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2019-01-14
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two kinds of therapy for Posttraumatic Stress Disorder (PTSD): exposure therapy (ET) and Interpersonal Psychotherapy (IPT). The results of this study will allow us to see if IPT and ET are equally effective in treating PTSD due to Military Sexual Trauma, with the long-term goal of making PTSD treatment effective for as many people as possible.


Eligibility criteria: Inclusion Criteria:

* English-speaking
* Military Sexual Trauma (MST) survivors, with MST defined as actual or threatened sexual violence, from Vietnam era to current Operation Iraqi Freedom/Operation Enduring Freedom/Operation New Dawn
* Diagnosed with PTSD consequent to MST, with a minimum CAPS score \> 40
* Medically stable at time of study enrollment (for persons with chronic injuries and that any disability present does not prevent attendance of weekly outpatient therapy sessions)
* Ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments
* Stable on psychotropic medication for the prior 60 days

Exclusion Criteria:

* Lifetime or current diagnosis of schizophrenia or other psychotic disorder, bipolar disorder
* Participation in a clinical trial or concurrent evidence-based treatment for MST-related psychiatric conditions or PTSD during the previous 3 months
* Current evidence of significant unstable medical illness or organic brain impairment such that the patient could not attend sessions regularly or complete assessments
* Patients who in the investigator's judgment pose a current homicidal or suicidal risk
* Current or history of substance dependence in the past 90 days.

Primary outcomes:
measure: Difference in mean Clinician Administered PTSD Scale-5 (CAPS-5) score changes between the Exposure Therapy (ET) and Interpersonal Psychotherapy (IPT) treatment groups from baseline to post-treatment
timeFrame: Baseline, 15 weeks in the IPT condition, 11 weeks in the ET condition
measure: Change in CAPS-5 scores from baseline to post-treatment for the ET treatment group
timeFrame: Baseline, 11 weeks
measure: Change in CAPS-5 scores from baseline to post-treatment for the IPT treatment group
timeFrame: Baseline, 15 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: JoAnn Difede, PhD
role: PRINCIPAL_INVESTIGATOR
References: