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

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: PTSD

Treatments: Behavioral: Exposure Therapy; Behavioral: Interpersonal Psychotherapy

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03803332

W81XWH-16-R-BAA1 (Other Grant/Funding Number)

1409015511

Details and patient eligibility

About

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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208 participants in 2 patient groups

Exposure Therapy

Active Comparator group

Description:

Participants receive 10 90-minute exposure therapy sessions for PTSD following the treatment procedures as outlined in the standard Prolonged Exposure therapy manual.

Treatment:

Behavioral: Exposure Therapy

Interpersonal Psychotherapy

Active Comparator group

Description:

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

Treatment:

Behavioral: Interpersonal Psychotherapy