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

NCT ID: NCT02417025

Last Updated: 2019-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2019-11-29

Brief Summary

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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

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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

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

Keywords

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Military Health Service Delivery Telepsychology Prolonged Exposure Off-duty Activity of Military Personnel

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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PE-HBT

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

Group Type EXPERIMENTAL

PE

Intervention Type BEHAVIORAL

Prolonged Exposure

PE-SD

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

Group Type ACTIVE_COMPARATOR

PE

Intervention Type BEHAVIORAL

Prolonged Exposure

Interventions

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PE

Prolonged Exposure

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Charleston Research Institute

OTHER

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald E Acierno, PhD

Role: PRINCIPAL_INVESTIGATOR

Ralph H. Johnson VA Medical Center

Locations

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Ralph H. Johnson VAMC

Charleston, South Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34391978 (View on PubMed)

Other Identifiers

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Pro00034989

Identifier Type: -

Identifier Source: org_study_id