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

Primary Purpose

PTSD, Stress Disorders, Post - Traumatic, Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PE
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring Military, Health Service Delivery, Telepsychology, Prolonged Exposure, Off-duty Activity of Military Personnel

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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).

Sites / Locations

  • Ralph H. Johnson VAMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PE-HBT

PE-SD

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
The VR-12 is short measure designed to assess participants' views on their current health, how they are feeling at this time point, and how well they are able to do their usual activities. It also asks questions regarding how daily activities are/have been hindered by problems with their physical health.
Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
The VR-12 is short measure designed to assess participants' views on their current health, how they are feeling at this time point, and how well they are able to do their usual activities. It also asks questions regarding how daily activities are/have been hindered by problems with their physical health.
Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
The VR-12 is short measure designed to assess participants' views on their current health, how they are feeling at this time point, and how well they are able to do their usual activities. It also asks questions regarding how daily activities are/have been hindered by problems with their physical health.
Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
The VR-12 is short measure designed to assess participants' views on their current health, how they are feeling at this time point, and how well they are able to do their usual activities. It also asks questions regarding how daily activities are/have been hindered by problems with their physical health.
Index of Functional Impairment (IFI)
The Index of Functional Impairment (IFI) is a self-report inventory of functional impairment. Patients rate their level of functioning across multiple psychosocial domains including romantic relationships, employment, and educational achievement.
Index of Functional Impairment (IFI)
The Index of Functional Impairment (IFI) is a self-report inventory of functional impairment. Patients rate their level of functioning across multiple psychosocial domains including romantic relationships, employment, and educational achievement.
Index of Functional Impairment (IFI)
The Index of Functional Impairment (IFI) is a self-report inventory of functional impairment. Patients rate their level of functioning across multiple psychosocial domains including romantic relationships, employment, and educational achievement.
Index of Functional Impairment (IFI)
The Index of Functional Impairment (IFI) is a self-report inventory of functional impairment. Patients rate their level of functioning across multiple psychosocial domains including romantic relationships, employment, and educational achievement.
Treatment Credibility Questionnaire
This questionnaire is used to assess for differences in outcome expectancy using treatment credibility scales. The questionnaire asks how the participant feels about the current treatment she is receiving, how logical it seems, how likely she would be to recommend it to a friend, and how successful she believes it is in decreasing different symptoms of PTSD, such as fear.
Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS)
The CPOSS is a 16-item questionnaire that assesses the participant's attitudes about the Charleston VA facility, such as the quality of care she received at the hospital, the helpfulness of the secretary, clear and correct monthly documentation of problems in her medical record, etc.
Mini International Neuropsychiatric Interview (M.I.N.I.)
The MINI is a brief structured interview that assesses the criteria for DSM-V Axis I diagnoses. The MINI will be used to assess for a diagnosis of current depression, panic symptoms, generalized anxiety symptoms, eating disorders, psychotic symptoms and to screen for substance dependence.
Mini International Neuropsychiatric Interview (M.I.N.I.)
The MINI is a brief structured interview that assesses the criteria for DSM-V Axis I diagnoses. The MINI will be used to assess for a diagnosis of current depression, panic symptoms, generalized anxiety symptoms, eating disorders, psychotic symptoms and to screen for substance dependence.
Alcohol Use Disorder Identification Test (AUDIT)
The AUDIT is a 10-item measure that assesses the level of the participant's drinking. Questions include how many drinks a participant has during a day or on occasions, possible harmful consequences of drinking, and feelings of remorse about drinking.
Alcohol Use Disorder Identification Test (AUDIT)
The AUDIT is a 10-item measure that assesses the level of the participant's drinking. Questions include how many drinks a participant has during a day or on occasions, possible harmful consequences of drinking, and feelings of remorse about drinking.
Alcohol Use Disorder Identification Test (AUDIT)
The AUDIT is a 10-item measure that assesses the level of the participant's drinking. Questions include how many drinks a participant has during a day or on occasions, possible harmful consequences of drinking, and feelings of remorse about drinking.
Alcohol Use Disorder Identification Test (AUDIT)
The AUDIT is a 10-item measure that assesses the level of the participant's drinking. Questions include how many drinks a participant has during a day or on occasions, possible harmful consequences of drinking, and feelings of remorse about drinking.
Drug Abuse Screening Test (DAST-10)
The DAST-10 is a 10-item measure designed to assess for illegal drug use (not including alcohol) for the past month.
Drug Abuse Screening Test (DAST-10)
The DAST-10 is a 10-item measure designed to assess for illegal drug use (not including alcohol) for the past month.
Drug Abuse Screening Test (DAST-10)
The DAST-10 is a 10-item measure designed to assess for illegal drug use (not including alcohol) for the past month.
Drug Abuse Screening Test (DAST-10)
The DAST-10 is a 10-item measure designed to assess for illegal drug use (not including alcohol) for the past month.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 19-item commonly used and well validated self-report measure of sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with rating of 5 or higher indicative of poor sleep quality.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 19-item commonly used and well validated self-report measure of sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with rating of 5 or higher indicative of poor sleep quality.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 19-item commonly used and well validated self-report measure of sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with rating of 5 or higher indicative of poor sleep quality.
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a 19-item commonly used and well validated self-report measure of sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with rating of 5 or higher indicative of poor sleep quality.
Sexual Assault Related Mental Contamination Scale (SARA)
This abbreviated version of the 80-item SARA scale assesses the participant's perceptions of her sexual assault/rape.
Sexual Assault Related Mental Contamination Scale (SARA)
This abbreviated version of the 80-item SARA scale assesses the participant's perceptions of her sexual assault/rape.
Sexual Assault Related Mental Contamination Scale (SARA)
This abbreviated version of the 80-item SARA scale assesses the participant's perceptions of her sexual assault/rape.
Sexual Assault Related Mental Contamination Scale (SARA)
This abbreviated version of the 80-item SARA scale assesses the participant's perceptions of her sexual assault/rape.
Beck Depression Inventory - II (BDI-II)
Beck Depression Inventory-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Beck Depression Inventory - II (BDI-II)
Beck Depression Inventory-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Beck Depression Inventory - II (BDI-II)
Beck Depression Inventory-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Beck Depression Inventory - II (BDI-II)
Beck Depression Inventory-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
PTSD Checklist, 5th Version (PCL-5)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including, monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Description information provided by the National Center for PTSD.
PTSD Checklist, 5th Version (PCL-5)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including, monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Description information provided by the National Center for PTSD.
PTSD Checklist, 5th Version (PCL-5)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including, monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Description information provided by the National Center for PTSD.
PTSD Checklist, 5th Version (PCL-5)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including, monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Description information provided by the National Center for PTSD.
Clinical Administrated PTSD Scale (CAPS)
The Clinician Administered PTSD (Posttraumatic stress disorder) Scale (CAPS) is a 30-item structured interview that corresponds to the Diagnostic and Statistical Manual of Mental Disorders, 5th Version (DSM-V) criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assesses symptoms over the past week.
Clinical Administrated PTSD Scale (CAPS)
The Clinician Administered PTSD (Posttraumatic stress disorder) Scale (CAPS) is a 30-item structured interview that corresponds to the Diagnostic and Statistical Manual of Mental Disorders, 5th Version (DSM-V) criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assesses symptoms over the past week.
Clinical Administrated PTSD Scale (CAPS)
The Clinician Administered PTSD (Posttraumatic stress disorder) Scale (CAPS) is a 30-item structured interview that corresponds to the Diagnostic and Statistical Manual of Mental Disorders, 5th Version (DSM-V) criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assesses symptoms over the past week.
Clinical Administrated PTSD Scale (CAPS)
The Clinician Administered PTSD (Posttraumatic stress disorder) Scale (CAPS) is a 30-item structured interview that corresponds to the Diagnostic and Statistical Manual of Mental Disorders, 5th Version (DSM-V) criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assesses symptoms over the past week.

Full Information

First Posted
December 15, 2014
Last Updated
December 23, 2019
Sponsor
Medical University of South Carolina
Collaborators
Charleston Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02417025
Brief Title
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 29, 2019 (Actual)
Study Completion Date
November 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
Charleston Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PE-HBT
Arm Type
Experimental
Arm Description
Prolonged Exposure via home-based telehealth (i.e., completed using videoconferencing technology)
Arm Title
PE-SD
Arm Type
Active Comparator
Arm Description
Prolonged Exposure via standard delivery (i.e., completed in person at the therapist's office)
Intervention Type
Behavioral
Intervention Name(s)
PE
Intervention Description
Prolonged Exposure
Primary Outcome Measure Information:
Title
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
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
Description
The VR-12 is short measure designed to assess participants' views on their current health, how they are feeling at this time point, and how well they are able to do their usual activities. It also asks questions regarding how daily activities are/have been hindered by problems with their physical health.
Time Frame
Baseline
Title
Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
Description
The VR-12 is short measure designed to assess participants' views on their current health, how they are feeling at this time point, and how well they are able to do their usual activities. It also asks questions regarding how daily activities are/have been hindered by problems with their physical health.
Time Frame
13 weeks
Title
Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
Description
The VR-12 is short measure designed to assess participants' views on their current health, how they are feeling at this time point, and how well they are able to do their usual activities. It also asks questions regarding how daily activities are/have been hindered by problems with their physical health.
Time Frame
24 weeks
Title
Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
Description
The VR-12 is short measure designed to assess participants' views on their current health, how they are feeling at this time point, and how well they are able to do their usual activities. It also asks questions regarding how daily activities are/have been hindered by problems with their physical health.
Time Frame
36 weeks
Title
Index of Functional Impairment (IFI)
Description
The Index of Functional Impairment (IFI) is a self-report inventory of functional impairment. Patients rate their level of functioning across multiple psychosocial domains including romantic relationships, employment, and educational achievement.
Time Frame
Baseline
Title
Index of Functional Impairment (IFI)
Description
The Index of Functional Impairment (IFI) is a self-report inventory of functional impairment. Patients rate their level of functioning across multiple psychosocial domains including romantic relationships, employment, and educational achievement.
Time Frame
13 weeks
Title
Index of Functional Impairment (IFI)
Description
The Index of Functional Impairment (IFI) is a self-report inventory of functional impairment. Patients rate their level of functioning across multiple psychosocial domains including romantic relationships, employment, and educational achievement.
Time Frame
24 weeks
Title
Index of Functional Impairment (IFI)
Description
The Index of Functional Impairment (IFI) is a self-report inventory of functional impairment. Patients rate their level of functioning across multiple psychosocial domains including romantic relationships, employment, and educational achievement.
Time Frame
36 weeks
Title
Treatment Credibility Questionnaire
Description
This questionnaire is used to assess for differences in outcome expectancy using treatment credibility scales. The questionnaire asks how the participant feels about the current treatment she is receiving, how logical it seems, how likely she would be to recommend it to a friend, and how successful she believes it is in decreasing different symptoms of PTSD, such as fear.
Time Frame
13 weeks
Title
Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS)
Description
The CPOSS is a 16-item questionnaire that assesses the participant's attitudes about the Charleston VA facility, such as the quality of care she received at the hospital, the helpfulness of the secretary, clear and correct monthly documentation of problems in her medical record, etc.
Time Frame
13 weeks
Title
Mini International Neuropsychiatric Interview (M.I.N.I.)
Description
The MINI is a brief structured interview that assesses the criteria for DSM-V Axis I diagnoses. The MINI will be used to assess for a diagnosis of current depression, panic symptoms, generalized anxiety symptoms, eating disorders, psychotic symptoms and to screen for substance dependence.
Time Frame
Baseline
Title
Mini International Neuropsychiatric Interview (M.I.N.I.)
Description
The MINI is a brief structured interview that assesses the criteria for DSM-V Axis I diagnoses. The MINI will be used to assess for a diagnosis of current depression, panic symptoms, generalized anxiety symptoms, eating disorders, psychotic symptoms and to screen for substance dependence.
Time Frame
36 weeks
Title
Alcohol Use Disorder Identification Test (AUDIT)
Description
The AUDIT is a 10-item measure that assesses the level of the participant's drinking. Questions include how many drinks a participant has during a day or on occasions, possible harmful consequences of drinking, and feelings of remorse about drinking.
Time Frame
Baseline
Title
Alcohol Use Disorder Identification Test (AUDIT)
Description
The AUDIT is a 10-item measure that assesses the level of the participant's drinking. Questions include how many drinks a participant has during a day or on occasions, possible harmful consequences of drinking, and feelings of remorse about drinking.
Time Frame
13 weeks
Title
Alcohol Use Disorder Identification Test (AUDIT)
Description
The AUDIT is a 10-item measure that assesses the level of the participant's drinking. Questions include how many drinks a participant has during a day or on occasions, possible harmful consequences of drinking, and feelings of remorse about drinking.
Time Frame
24 weeks
Title
Alcohol Use Disorder Identification Test (AUDIT)
Description
The AUDIT is a 10-item measure that assesses the level of the participant's drinking. Questions include how many drinks a participant has during a day or on occasions, possible harmful consequences of drinking, and feelings of remorse about drinking.
Time Frame
36 weeks
Title
Drug Abuse Screening Test (DAST-10)
Description
The DAST-10 is a 10-item measure designed to assess for illegal drug use (not including alcohol) for the past month.
Time Frame
Baseline
Title
Drug Abuse Screening Test (DAST-10)
Description
The DAST-10 is a 10-item measure designed to assess for illegal drug use (not including alcohol) for the past month.
Time Frame
13 weeks
Title
Drug Abuse Screening Test (DAST-10)
Description
The DAST-10 is a 10-item measure designed to assess for illegal drug use (not including alcohol) for the past month.
Time Frame
24 weeks
Title
Drug Abuse Screening Test (DAST-10)
Description
The DAST-10 is a 10-item measure designed to assess for illegal drug use (not including alcohol) for the past month.
Time Frame
36 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
The PSQI is a 19-item commonly used and well validated self-report measure of sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with rating of 5 or higher indicative of poor sleep quality.
Time Frame
Baseline
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
The PSQI is a 19-item commonly used and well validated self-report measure of sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with rating of 5 or higher indicative of poor sleep quality.
Time Frame
13 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
The PSQI is a 19-item commonly used and well validated self-report measure of sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with rating of 5 or higher indicative of poor sleep quality.
Time Frame
24 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
The PSQI is a 19-item commonly used and well validated self-report measure of sleep quality and disturbance. Scores on the PSQI range from 0 to 21, with rating of 5 or higher indicative of poor sleep quality.
Time Frame
36 weeks
Title
Sexual Assault Related Mental Contamination Scale (SARA)
Description
This abbreviated version of the 80-item SARA scale assesses the participant's perceptions of her sexual assault/rape.
Time Frame
Baseline
Title
Sexual Assault Related Mental Contamination Scale (SARA)
Description
This abbreviated version of the 80-item SARA scale assesses the participant's perceptions of her sexual assault/rape.
Time Frame
13 weeks
Title
Sexual Assault Related Mental Contamination Scale (SARA)
Description
This abbreviated version of the 80-item SARA scale assesses the participant's perceptions of her sexual assault/rape.
Time Frame
24 weeks
Title
Sexual Assault Related Mental Contamination Scale (SARA)
Description
This abbreviated version of the 80-item SARA scale assesses the participant's perceptions of her sexual assault/rape.
Time Frame
36 weeks
Title
Beck Depression Inventory - II (BDI-II)
Description
Beck Depression Inventory-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Time Frame
Baseline
Title
Beck Depression Inventory - II (BDI-II)
Description
Beck Depression Inventory-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Time Frame
13 weeks
Title
Beck Depression Inventory - II (BDI-II)
Description
Beck Depression Inventory-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Time Frame
24 weeks
Title
Beck Depression Inventory - II (BDI-II)
Description
Beck Depression Inventory-II is a 21 item measure of depressive severity with higher total scores indicative of more severe depression.
Time Frame
36 weeks
Title
PTSD Checklist, 5th Version (PCL-5)
Description
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including, monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Description information provided by the National Center for PTSD.
Time Frame
Baseline
Title
PTSD Checklist, 5th Version (PCL-5)
Description
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including, monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Description information provided by the National Center for PTSD.
Time Frame
13 weeks
Title
PTSD Checklist, 5th Version (PCL-5)
Description
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including, monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Description information provided by the National Center for PTSD.
Time Frame
24 weeks
Title
PTSD Checklist, 5th Version (PCL-5)
Description
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The PCL-5 has a variety of purposes, including, monitoring symptom change during and after treatment, screening individuals for PTSD, and making a provisional PTSD diagnosis. Description information provided by the National Center for PTSD.
Time Frame
36 weeks
Title
Clinical Administrated PTSD Scale (CAPS)
Description
The Clinician Administered PTSD (Posttraumatic stress disorder) Scale (CAPS) is a 30-item structured interview that corresponds to the Diagnostic and Statistical Manual of Mental Disorders, 5th Version (DSM-V) criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assesses symptoms over the past week.
Time Frame
Baseline
Title
Clinical Administrated PTSD Scale (CAPS)
Description
The Clinician Administered PTSD (Posttraumatic stress disorder) Scale (CAPS) is a 30-item structured interview that corresponds to the Diagnostic and Statistical Manual of Mental Disorders, 5th Version (DSM-V) criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assesses symptoms over the past week.
Time Frame
13 weeks
Title
Clinical Administrated PTSD Scale (CAPS)
Description
The Clinician Administered PTSD (Posttraumatic stress disorder) Scale (CAPS) is a 30-item structured interview that corresponds to the Diagnostic and Statistical Manual of Mental Disorders, 5th Version (DSM-V) criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assesses symptoms over the past week.
Time Frame
24 weeks
Title
Clinical Administrated PTSD Scale (CAPS)
Description
The Clinician Administered PTSD (Posttraumatic stress disorder) Scale (CAPS) is a 30-item structured interview that corresponds to the Diagnostic and Statistical Manual of Mental Disorders, 5th Version (DSM-V) criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assesses symptoms over the past week.
Time Frame
36 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: MST-related index event Diagnosis of PTSD-related MST Female Exclusion Criteria: Having a household member of spouse who is already enrolled in the study Active psychosis or dementia Suicidal and/or homicidal ideation with clear intent Current substance dependence Concurrent enrollment in another clinical trial for PTSD or depression 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald E Acierno, PhD
Organizational Affiliation
Ralph H. Johnson VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ralph H. Johnson VAMC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34391978
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.
Results Reference
derived

Learn more about this trial

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

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