A Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Due to Military Sexual Trauma (MST) in Male and Female Military Personnel
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exposure Therapy, Interpersonal Psychotherapy.
- Who it may be relevant to
- Registry conditions: PTSD. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Non-Inferiority Randomized Controlled Clinical Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Consequent to Military Sexual Trauma
Overview
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.
Interventions
- Behavioral Exposure Therapy
Psychotherapy including imaginal and in vivo exposure for PTSD. - Behavioral Interpersonal Psychotherapy
Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning.
Primary outcome measures
- 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 [Time frame: Baseline, 15 weeks in the IPT condition, 11 weeks in the ET condition]
- Change in CAPS-5 scores from baseline to post-treatment for the ET treatment group [Time frame: Baseline, 11 weeks]
- Change in CAPS-5 scores from baseline to post-treatment for the IPT treatment group [Time frame: Baseline, 15 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Weill Cornell Medicine — New York
Identifiers
NCT: NCT03803332 · 1409015511 · W81XWH-16-R-BAA1