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

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

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: Exposure Therapy
* Behavioral: Interpersonal Psychotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exposure Therapy<br>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<br>* Psychotherapy including imaginal and in vivo exposure for PTSD.<br>* Other names: Prolonged Exposure;|
| Active Comparator: Interpersonal Psychotherapy<br>Participants receive 14 weekly 50-minute Interpersonal Psychotherapy sessions focused on the interpersonal sequelae of trauma in current daily life. | Behavioral: Interpersonal Psychotherapy<br>* Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Military Sexual Trauma, exposure therapy, interpersonal psychotherapy, treatment