Health Trials

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

ConditionPTSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorWeill Medical College of Cornell University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exposure Therapy

    Behavioral

    Psychotherapy including imaginal and in vivo exposure for PTSD.

  • Interpersonal Psychotherapy

    Behavioral

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

Treatment groups

208 Participants
are divided into 2 treatment groups
Group A: Exposure TherapyActive comparator 1 intervention
Group B: Interpersonal PsychotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

The CAPS-5 is used for rating the severity of PTSD symptoms. Scores range from 0-80 with higher scores indicating greater PTSD severity

Time frame
Baseline, 15 weeks in the IPT condition, 11 weeks in the ET condition
2

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

Time frame
Baseline, 11 weeks
3

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

Time frame
Baseline, 15 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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