NCT02417025

Innovative Delivery of Evidence Based Psychotherapy to Women With Military Sexual Trauma

Do You Really Expect Me to Get MST Care in a VA Where Everyone is Male? Innovative Delivery of Evidence Based Psychotherapy to Women With Military Sexual Trauma (MST)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether a scientifically validated treatment for Posttraumatic Stress Disorder (PTSD) called Prolonged Exposure (PE) can be delivered effectively to Veterans with Military Sexual Trauma (MST) related PTSD using videoconferencing technology, which allows a therapist and patient who are not in the same room as one another to communicate. The investigators are interested in learning if this form of mental health service delivery is an acceptable alternative to traditional face-to-face therapy delivered with the therapist in the same room as the patient. This study is being conducted at the Charleston VA Medical Center and surrounding Community-Based Outpatient Clinics (CBOCs), and will involve approximately 100 female participants.

Detailed description

The purpose of this project is to test, using mixed qualitative and quantitative assessment strategies, the efficacy of PE delivered via home-based telehealth (PE-HBT) versus PE delivered via standard service delivery (PE-SD) using a randomized, between groups, repeated measures design. Objective 1: To compare, at post, 3 and 6-month follow-up, whether PE-HBT is superior to PE-SD across critical clinical and quality of life outcomes (i.e., PTSD, depression, quality of life) due to increased PE 'dosing' that results from improved session attendance and reduced attrition. Hypothesis 1: In intent-to-treat analyses, PE-HBT will be more effective than PE-SD at improving clinical and quality of life outcomes at post, 3, and 6-month follow-up; improvement will correlate with session attendance, which will be higher in PE-HBT. Objective 2: To compare at post-intervention whether PE-HBT is superior to PE-SD across critical process outcomes (e.g., session attendance, satisfaction, and treatment adherence). Hypothesis 2: PE-HBT will yield better process outcomes than PE-SD post-intervention. Exploratory Aims: (1) To determine if treatment adherence and other process variables mediate the relationship between treatment condition and clinical and quality of life outcomes as noted in Objective 1; and (2) To use qualitative interviewing methods to obtain data on Veterans' reactions, preferences, difficulties, and suggestions for MST services.

Conditions

• PTSD
• Stress Disorders, Post - Traumatic
• Anxiety Disorders
• Mental Disorders
• Stress Disorders, Traumatic

Interventions

Type	Name	Description
BEHAVIORAL	PE	Prolonged Exposure

Timeline

• Start date: 2014-08-01
• Primary completion: 2019-11-29
• Completion: 2019-11-29
• First posted: 2015-04-15
• Last updated: 2019-12-24

Locations

1 site across 1 country: United States