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

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03803332
• Other study ID #: 1409015511
• Secondary ID: W81XWH-16-R-BAA1
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2020
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: Weill Medical College of Cornell University
• Contact: Olivia Baryluk, BS
• Phone: 212-821-0783
• Email: olb4002[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: September 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Exposure Therapy
Psychotherapy including imaginal and in vivo exposure for PTSD.
• Interpersonal Psychotherapy
Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity	Baseline, 15 weeks in the IPT condition, 11 weeks in the ET condition
Primary	Change in CAPS-5 scores from baseline to post-treatment for the ET treatment group	The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity	Baseline, 11 weeks
Primary	Change in CAPS-5 scores from baseline to post-treatment for the IPT treatment group	The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity	Baseline, 15 weeks