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

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Mental Disorders; PTSD; Stress Disorders, Traumatic; Stress Disorders, Post - Traumatic; Anxiety Disorders

Treatments: Behavioral: PE

Study type: Interventional

Funder types: Other

Identifiers

NCT02417025

Pro00034989

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. MST-related index event
2. Diagnosis of PTSD-related MST
3. Female

Exclusion criteria

1. Having a household member of spouse who is already enrolled in the study
2. Active psychosis or dementia
3. Suicidal and/or homicidal ideation with clear intent
4. Current substance dependence
5. Concurrent enrollment in another clinical trial for PTSD or depression
6. Unwilling to make regular appointments (note that if the participant has medical/transportation barriers that render her unable to make set appointments, this is not grounds for exclusion).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

136 participants in 2 patient groups

PE-HBT

Experimental group

Description:

Prolonged Exposure via home-based telehealth (i.e., completed using videoconferencing technology)

Treatment:

Behavioral: PE

PE-SD

Active Comparator group

Description:

Prolonged Exposure via standard delivery (i.e., completed in person at the therapist's office)

Treatment:

Behavioral: PE