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

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03803332

Collaborator

United States Department of Defense (U.S. Fed)

208

Enrollment

Location

Arms

52.8

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PTSD	Behavioral: Exposure Therapy Behavioral: Interpersonal Psychotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

208 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 9, 2020

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Behavioral: Exposure Therapy Psychotherapy including imaginal and in vivo exposure for PTSD. Other Names: Prolonged Exposure
Active Comparator: Interpersonal Psychotherapy Participants receive 14 weekly 50-minute Interpersonal Psychotherapy sessions focused on the interpersonal sequelae of trauma in current daily life.	Behavioral: Interpersonal Psychotherapy Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning.

Arm

Intervention/Treatment

Active Comparator: 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.

Behavioral: Exposure Therapy

Psychotherapy including imaginal and in vivo exposure for PTSD.

Other Names:

Prolonged Exposure

Active Comparator: Interpersonal Psychotherapy

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

Behavioral: Interpersonal Psychotherapy

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

Outcome Measures

Primary Outcome Measures

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 [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
Change in CAPS-5 scores from baseline to post-treatment for the ET treatment group [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
Change in CAPS-5 scores from baseline to post-treatment for the IPT treatment group [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.