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

NCT ID: NCT03803332

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-09

Study Completion Date

2026-09-30

Brief Summary

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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

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Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Exposure Therapy

Intervention Type BEHAVIORAL

Psychotherapy including imaginal and in vivo exposure for PTSD.

Interpersonal Psychotherapy

Participants receive 14 weekly 50-minute Interpersonal Psychotherapy sessions focused on the interpersonal sequelae of trauma in current daily life.

Group Type ACTIVE_COMPARATOR

Interpersonal Psychotherapy

Intervention Type BEHAVIORAL

Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning.

Interventions

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Exposure Therapy

Psychotherapy including imaginal and in vivo exposure for PTSD.

Intervention Type BEHAVIORAL

Interpersonal Psychotherapy

Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning.

Intervention Type BEHAVIORAL

Other Intervention Names

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Prolonged Exposure

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JoAnn Difede, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medicine

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Olivia Baryluk, BS

Role: CONTACT

212-821-0783

Facility Contacts

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Olivia Baryluk, BS

Role: primary

212-821-0783

Other Identifiers

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W81XWH-16-R-BAA1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1409015511

Identifier Type: -

Identifier Source: org_study_id