RECRUITING

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

Conditions

PTSD Military Sexual Trauma exposure therapy interpersonal psychotherapy treatment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-03-09

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03803332

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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

Study Contact

Olivia Baryluk, BS

CONTACT

212-821-0783

olb4002@med.cornell.edu

Principal Investigator

JoAnn Difede, PhD

PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

JoAnn Difede, PhD, PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-09

Study Completion Date2025-09

Study Record Updates

Study Start Date2020-03-09

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

PTSD
Military Sexual Trauma
exposure therapy
interpersonal psychotherapy
treatment

Additional Relevant MeSH Terms

PTSD