Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803332
Recruitment Status : Suspended (Per IRB COVID-19 guidance on conducting human subjects research.)
First Posted : January 14, 2019
Last Update Posted : March 31, 2020
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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

Layout table for study information
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

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803332


Locations
Layout table for location information
United States, New York
Weill Cornell Medicine
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
United States Department of Defense
Investigators
Layout table for investigator information
Principal Investigator: JoAnn Difede, PhD Weill Cornell Medicine
Layout table for additonal 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    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Wounds and Injuries
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders