Clinical trial NCT02417025: Innovative Delivery of Evidence Based Psychotherapy to Women With Military Sexual Trauma
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Stress Disorders, Post - Traumatic
Anxiety Disorders
Mental Disorders
Stress Disorders, Traumatic
Keywords: Military
Health Service Delivery
Telepsychology
Prolonged Exposure
Off-duty Activity of Military Personnel
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Charleston Research Institute
First posted: 2015-04-15
Enrollment: 136
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of Participants Receiving Prolonged Exposure Treatment via Telemedicine with significantly decreased PTSD symptoms Compared to Number of Participants Receiving Prolonged Exposure Treatment with Standard In-Person Delivery
timeFrame: 36 weeks
Secondary outcomes:
measure: Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
timeFrame: Baseline
measure: Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
timeFrame: 13 weeks
measure: Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
timeFrame: 24 weeks
measure: Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
timeFrame: 36 weeks
measure: Index of Functional Impairment (IFI)
timeFrame: Baseline
measure: Index of Functional Impairment (IFI)
timeFrame: 13 weeks
measure: Index of Functional Impairment (IFI)
timeFrame: 24 weeks
measure: Index of Functional Impairment (IFI)
timeFrame: 36 weeks
measure: Treatment Credibility Questionnaire
timeFrame: 13 weeks
measure: Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS)
timeFrame: 13 weeks
measure: Mini International Neuropsychiatric Interview (M.I.N.I.)
timeFrame: Baseline
measure: Mini International Neuropsychiatric Interview (M.I.N.I.)
timeFrame: 36 weeks
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: Baseline
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: 13 weeks
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: 24 weeks
measure: Alcohol Use Disorder Identification Test (AUDIT)
timeFrame: 36 weeks
measure: Drug Abuse Screening Test (DAST-10)
timeFrame: Baseline
measure: Drug Abuse Screening Test (DAST-10)
timeFrame: 13 weeks
measure: Drug Abuse Screening Test (DAST-10)
timeFrame: 24 weeks
measure: Drug Abuse Screening Test (DAST-10)
timeFrame: 36 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 13 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 24 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 36 weeks
measure: Sexual Assault Related Mental Contamination Scale (SARA)
timeFrame: Baseline
measure: Sexual Assault Related Mental Contamination Scale (SARA)
timeFrame: 13 weeks
measure: Sexual Assault Related Mental Contamination Scale (SARA)
timeFrame: 24 weeks
measure: Sexual Assault Related Mental Contamination Scale (SARA)
timeFrame: 36 weeks
measure: Beck Depression Inventory - II (BDI-II)
timeFrame: Baseline
measure: Beck Depression Inventory - II (BDI-II)
timeFrame: 13 weeks
measure: Beck Depression Inventory - II (BDI-II)
timeFrame: 24 weeks
measure: Beck Depression Inventory - II (BDI-II)
timeFrame: 36 weeks
measure: PTSD Checklist, 5th Version (PCL-5)
timeFrame: Baseline
measure: PTSD Checklist, 5th Version (PCL-5)
timeFrame: 13 weeks
measure: PTSD Checklist, 5th Version (PCL-5)
timeFrame: 24 weeks
measure: PTSD Checklist, 5th Version (PCL-5)
timeFrame: 36 weeks
measure: Clinical Administrated PTSD Scale (CAPS)
timeFrame: Baseline
measure: Clinical Administrated PTSD Scale (CAPS)
timeFrame: 13 weeks
measure: Clinical Administrated PTSD Scale (CAPS)
timeFrame: 24 weeks
measure: Clinical Administrated PTSD Scale (CAPS)
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VAMC
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center
name: Ronald E Acierno, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Acierno R, Jaffe AE, Gilmore AK, Birks A, Denier C, Muzzy W, Lopez CM, Tuerk P, Grubaugh AL. A randomized clinical trial of in-person vs. home-based telemedicine delivery of Prolonged Exposure for PTSD in military sexual trauma survivors. J Anxiety Disord. 2021 Oct;83:102461. doi: 10.1016/j.janxdis.2021.102461. Epub 2021 Aug 8.