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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03803332
Enrollment
208
Registered
2019-01-14
Start date
2020-03-09
Completion date
2027-09-01
Last updated
2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PTSD

Keywords

PTSD, Military Sexual Trauma, exposure therapy, interpersonal psychotherapy, treatment

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.

Interventions

BEHAVIORALExposure Therapy

Psychotherapy including imaginal and in vivo exposure for PTSD.

BEHAVIORALInterpersonal Psychotherapy

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

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER
United States Department of Defense
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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-treatmentBaseline, 15 weeks in the IPT condition, 11 weeks in the ET conditionThe 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 groupBaseline, 11 weeksThe 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 IPT treatment groupBaseline, 15 weeksThe CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity

Countries

United States

Contacts

CONTACTOlivia Baryluk, BS
olb4002@med.cornell.edu212-821-0783
PRINCIPAL_INVESTIGATORJoAnn Difede, PhD

Weill Medical College of Cornell University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026