A Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Due to Military Sexual Trauma (MST) in Male and Female Military Personnel

Not Applicable

Recruiting

• Conditions: PTSD
• Interventions: Behavioral: Interpersonal Psychotherapy; Behavioral: Exposure Therapy

• Registration Number: NCT03803332
• Lead Sponsor: Weill Medical College of Cornell University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-14
• Study Start: 2020-03-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-03
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 208

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interpersonal Psychotherapy	Interpersonal Psychotherapy	Participants receive 14 weekly 50-minute Interpersonal Psychotherapy sessions focused on the interpersonal sequelae of trauma in current daily life.
Exposure Therapy	Exposure Therapy	Participants receive 10 90-minute exposure therapy sessions for PTSD following the treatment procedures as outlined in the standard Prolonged Exposure therapy manual.

Primary Outcome Measures

Name	Time	Method
Change in CAPS-5 scores from baseline to post-treatment for the IPT treatment group	Baseline, 15 weeks	The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity
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	Baseline, 15 weeks in the IPT condition, 11 weeks in the ET condition	The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity
Change in CAPS-5 scores from baseline to post-treatment for the ET treatment group	Baseline, 11 weeks	The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States