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

Anxiety Disorders Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417025
• Other study ID #: Pro00034989
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: November 29, 2019

Study information

• Verified date: December 2019
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: November 29, 2019
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• PE
Prolonged Exposure

Locations

Country	Name	City	State
United States	Ralph H. Johnson VAMC	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Charleston Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		36 weeks
Secondary	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.	Baseline
Secondary	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.	13 weeks
Secondary	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.	24 weeks
Secondary	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.	36 weeks
Secondary	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.	Baseline
Secondary	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.	13 weeks
Secondary	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.	24 weeks
Secondary	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.	36 weeks
Secondary	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.	13 weeks
Secondary	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.	13 weeks
Secondary	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.	Baseline
Secondary	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.	36 weeks
Secondary	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.	Baseline
Secondary	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.	13 weeks
Secondary	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.	24 weeks
Secondary	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.	36 weeks
Secondary	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.	Baseline
Secondary	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.	13 weeks
Secondary	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.	24 weeks
Secondary	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.	36 weeks
Secondary	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.	Baseline
Secondary	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.	13 weeks
Secondary	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.	24 weeks
Secondary	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.	36 weeks
Secondary	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.	Baseline
Secondary	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.	13 weeks
Secondary	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.	24 weeks
Secondary	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.	36 weeks
Secondary	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.	Baseline
Secondary	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.	13 weeks
Secondary	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.	24 weeks
Secondary	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.	36 weeks
Secondary	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.	Baseline
Secondary	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.	13 weeks
Secondary	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.	24 weeks
Secondary	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.	36 weeks
Secondary	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.	Baseline
Secondary	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.	13 weeks
Secondary	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.	24 weeks
Secondary	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.	36 weeks