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
2 other identifiers
interventional
208
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2019
CompletedFirst Posted
Study publicly available on registry
January 14, 2019
CompletedStudy Start
First participant enrolled
March 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
April 16, 2026
April 1, 2026
7 years
January 11, 2019
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Exposure Therapy
ACTIVE COMPARATORParticipants receive 10 90-minute exposure therapy sessions for PTSD following the treatment procedures as outlined in the standard Prolonged Exposure therapy manual.
Interpersonal Psychotherapy
ACTIVE COMPARATORParticipants receive 14 weekly 50-minute Interpersonal Psychotherapy sessions focused on the interpersonal sequelae of trauma in current daily life.
Interventions
Psychotherapy including imaginal and in vivo exposure for PTSD.
Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weill Cornell Medicine
New York, New York, 10065, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JoAnn Difede, PhD
Weill Medical College of Cornell University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2019
First Posted
January 14, 2019
Study Start
March 9, 2020
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share