Innovative Delivery of Evidence Based Psychotherapy to Women With Military Sexual Trauma
| Status: | Recruiting |
|---|---|
| Conditions: | Anxiety, Psychiatric, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 7/20/2018 |
| Start Date: | August 2014 |
| End Date: | August 2019 |
| Contact: | Ronald E Acierno, PhD |
| Email: | acierno@musc.edu |
| Phone: | 843-792-2949 |
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)
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.
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.
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.
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.
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).
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