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NCT Number: NCT03803332

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

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.

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Key information

Conditions

PTSD Mental Disorders Military Sexual Trauma Sexual Trauma Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10065, United States

Location status: Recruiting

Location contact

Olivia Baryluk, BS

CONTACT

[email protected]

212-821-0783

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exposure Therapy

Behavioral

Psychotherapy including imaginal and in vivo exposure for PTSD.

Other names: Prolonged Exposure

interpersonal psychotherapy

Behavioral

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

Primary outcomes

  1. 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

    Time frame: 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

  2. Change in CAPS-5 scores from baseline to post-treatment for the ET treatment group

    Time frame: 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

  3. Change in CAPS-5 scores from baseline to post-treatment for the IPT treatment group

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Olivia Baryluk, BS

CONTACT

[email protected]

212-821-0783

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jan 14, 2019
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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