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

A Non-Inferiority Randomized Controlled Clinical Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Consequent to Military Sexual Trauma

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.

Study Overview

• Status: Recruiting
• Conditions: PTSD
• Intervention / Treatment: Behavioral: Exposure Therapy; Behavioral: Interpersonal Psychotherapy

• Study Type: Interventional
• Enrollment (Estimated): 208
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivia Baryluk, BS; Phone Number: 212-821-0783; Email: olb4002@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine
      • Contact: Olivia Baryluk, BS; Phone Number: 212-821-0783; Email: olb4002@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Exposure Therapy; Psychotherapy including imaginal and in vivo exposure for PTSD.; Other Names: Prolonged Exposure
Active Comparator: Interpersonal Psychotherapy; Participants receive 14 weekly 50-minute Interpersonal Psychotherapy sessions focused on the interpersonal sequelae of trauma in current daily life.	Behavioral: Interpersonal Psychotherapy; Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: JoAnn Difede, PhD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2020
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; treatment; exposure therapy; interpersonal psychotherapy; Military Sexual Trauma
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Sexual Trauma; Stress Disorders, Post-Traumatic; Military Sexual Trauma; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Desensitization, Psychologic; Interpersonal Psychotherapy; Implosive Therapy
• Other Study ID Numbers: 1409015511; W81XWH-16-R-BAA1 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No