A Non-Inferiority Randomized Controlled Clinical Trial Comparing Interpersonal Therapy to Exposure Therapy for PTSD Consequent to Military Sexual Trauma (MST) in Male and Female Military Personnel and Veterans

Clinical Trial Details

Military sexual trauma (MST) is defined as uninvited/unwanted sexual attention (such as touching, cornering, pressure for sexual favors, or verbal remarks), threat of or attempted
sexual contact, sexual assault, or any sort of sexual activity between at least two people in which one of the people is involved against their will. This research is being done because MST has been identified as a pervasive problem with profound psychological and physical consequences.

The purpose of this study is to compare two kinds of therapy for post-traumatic stress disorder (PTSD) due to MST: prolonged exposure therapy (PE) and interpersonal psychotherapy (IPT). The results of this study will allow us to see if IPT and PE 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.

Participants will be randomized into one of two study groups and will receive either PE or IPT. Randomization means that you are put into a group by chance, similar to flipping a coin.

IPT focuses on addressing the effects PTSD has had on relationships with other people through talking about emotions in response to recent interactions with others.

PE focuses on teaching individuals to gradually approach their trauma-related memories, feelings, and situations to gain confidence in their ability to manage them. The therapist will monitor distress levels during the sessions.

Participation consists of 10 weekly sessions for the PE group and 14 weekly sessions for the IPT group. All participants will also complete a post-treatment assessment and a six-month follow-up assessment after finishing the weekly therapy sessions therapy. Total participation in the study will be approximately 10 months.

The information discussed during both IPT, and PE sessions is completely confidential and will not be shared with anyone outside of this research study. All services provided are separate from the United States Department of Veteran Affairs (VA), the Department of Defense (DOD), the Veterans Health Administration (VHA), Military Behavioral Health, or any other military institution.

If you are interested in hearing more about the study, please call 212-821-0783.

Key Eligibility:

Inclusion Criteria

English-speaking
Age 18 to 70.
Member of the miltary from any service era, with any duty status and any discharge status who is an MST survivor
Ability to attend weekly outpatient therapy sessions
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 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

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Olivia Baryluk
212-821-0783
olb4002@med.cornell.edu

Westchester

Contact(s)

Olivia Baryluk
212-821-0783
olb4002@med.cornell.edu

Primary Investigator(s)

JoAnn Difede, PhD

Protocol ID(s)

Weill Cornell Medicine IRB #:

1409015511

ClinicalTrials.gov:

NCT03803332

Status

Open to Enrollment

Age Group

Adult

Disease

Mental Health

PTSD