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

• ClinicalTrials.gov Identifier: NCT03803332
• Recruitment Status: Recruiting
• First Posted: January 14, 2019
• Last Update Posted: October 13, 2022
• Sponsor: Weill Medical College of Cornell University
• Collaborator: United States Department of Defense
• Information provided by (Responsible Party): Weill Medical College of Cornell University

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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: March 9, 2020
• Estimated Primary Completion Date: March 2024
• Estimated Study Completion Date: August 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 Name: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Olivia Baryluk, BS; 212-821-0783; olb4002@med.cornell.edu

Locations

United States, New York

Weill Cornell Medicine; Recruiting

New York, New York, United States, 10065

Contact: Olivia Baryluk, BS 212-821-0783 olb4002@med.cornell.edu

Sponsors and Collaborators

Weill Medical College of Cornell University

United States Department of Defense

Investigators

• Principal Investigator: JoAnn Difede, PhD; Weill Medical College of Cornell University

More Information

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT03803332
• Other Study ID Numbers: 1409015511; W81XWH-16-R-BAA1 ( Other Grant/Funding Number: Department of Defense )
• First Posted: January 14, 2019
• Last Update Posted: October 13, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Weill Medical College of Cornell University:

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

Additional relevant MeSH terms:

Sexual Trauma; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders