Comparing two therapies for PTSD in military personnel
A Non-Inferiority Randomized Controlled Clinical Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Consequent to Military Sexual Trauma
This study tests whether two different therapies for PTSD, Exposure Therapy and Interpersonal Psychotherapy, work equally well for military personnel who have experienced Military Sexual Trauma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 208 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03803332 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two therapeutic approaches for treating Posttraumatic Stress Disorder (PTSD) resulting from Military Sexual Trauma (MST): Exposure Therapy (ET) and Interpersonal Psychotherapy (IPT). Participants will include English-speaking military personnel who are survivors of MST and have been diagnosed with PTSD. The study will assess whether IPT and ET yield similar outcomes in alleviating PTSD symptoms, with the ultimate goal of improving treatment options for affected individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are English-speaking military personnel who are survivors of Military Sexual Trauma and have a PTSD diagnosis.
Not a fit: Patients with a lifetime or current diagnosis of schizophrenia, bipolar disorder, or those currently participating in other PTSD treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into effective PTSD treatments for military personnel, potentially improving their mental health outcomes.
How similar studies have performed: Other studies have explored various therapeutic approaches for PTSD, but this specific comparison of IPT and ET for MST-related PTSD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: JoAnn Difede, PhD — Weill Medical College of Cornell University
- Study coordinator: Olivia Baryluk, BS
- Email: olb4002@med.cornell.edu
- Phone: 212-821-0783
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.