PTSDNCT02417025
Innovative Delivery of Evidence Based Psychotherapy to Women With Military Sexual Trauma
A study testing PE in people with PTSD and Stress Disorders, Post - Traumatic, run by Medical University of South Carolina at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- PTSD, Stress Disorders, Post - Traumatic, Anxiety Disorders
- What is being tested?
- PE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 29 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MST-related index event
- Diagnosis of PTSD-related MST
- Female
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Ralph H. Johnson VAMC
Charleston, South Carolina, 29401
About this study
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)
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.
Read the 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.
- Conditions
- PTSD, Stress Disorders, Post - Traumatic, Anxiety Disorders, Mental Disorders, Stress Disorders, Traumatic
- Being tested
- PE
- Keywords
- Military, Health Service Delivery, Telepsychology, Prolonged Exposure, Off-duty Activity of Military Personnel
- Medical subject headings
- Stress Disorders, Post-Traumatic, Combat Disorders, Anxiety Disorders, Mental Disorders, Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEBehavioural
Prolonged Exposure
| Study group | Role | What they receive |
|---|---|---|
| PE-HBT | Experimental | Prolonged Exposure via home-based telehealth (i.e., completed using videoconferencing technology) Receives: Behavioral: PE |
| PE-SD | Active comparator | Prolonged Exposure via standard delivery (i.e., completed in person at the therapist's office) Receives: Behavioral: PE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 36 weeks
Secondary outcomes (40)
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.
Measured: Baseline
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.
Measured: 13 weeks
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.
Measured: 24 weeks
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.
Measured: 36 weeks
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.
Measured: Baseline
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.
Measured: 13 weeks
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.
Measured: 24 weeks
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.
Measured: 36 weeks
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.
Measured: 13 weeks
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.
Measured: 13 weeks
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.
Measured: Baseline
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.
Measured: 36 weeks
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.
Measured: Baseline
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.
Measured: 13 weeks
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.
Measured: 24 weeks
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.
Measured: 36 weeks
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.
Measured: Baseline
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.
Measured: 13 weeks
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.
Measured: 24 weeks
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.
Measured: 36 weeks
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.
Measured: Baseline
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.
Measured: 13 weeks
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.
Measured: 24 weeks
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.
Measured: 36 weeks
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.
Measured: Baseline
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.
Measured: 13 weeks
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.
Measured: 24 weeks
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.
Measured: 36 weeks
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.
Measured: Baseline
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.
Measured: 13 weeks
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.
Measured: 24 weeks
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.
Measured: 36 weeks
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.
Measured: Baseline
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.
Measured: 13 weeks
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.
Measured: 24 weeks
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.
Measured: 36 weeks
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.
Measured: Baseline
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.
Measured: 13 weeks
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.
Measured: 24 weeks
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.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startAug 2014
- Primary completion29 Nov 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Charleston Research Institute
- Responsible party
- Sponsor
- Investigators
- Ronald E Acierno, PhD, Principal investigator, Ralph H. Johnson VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417025
- Sponsor's protocol ID
- Pro00034989
- Status last verified
- Dec 2019
- First submitted
- 15 Dec 2014
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34391978
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02417025
- Acronym / sponsor ID
- Pro00034989
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Charleston Research Institute
- Study start
- Aug 2014
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PE-HBT | Experimental | Behavioral: PEProlonged Exposure via home-based telehealth (i.e., completed using videoconferencing technology) |
| PE-SD | Active comparator | Behavioral: PEProlonged Exposure via standard delivery (i.e., completed in person at the therapist's office) |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- MST-related index event
- Diagnosis of PTSD-related MST
- Female
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEProlonged Exposure | Behavioural | PE-HBT, PE-SD |
Primary outcome
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
40 secondary outcomes
Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
Time frame: Baseline
Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
Time frame: 13 weeks
Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
Time frame: 24 weeks
Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
Time frame: 36 weeks
Index of Functional Impairment (IFI)
Time frame: Baseline
Index of Functional Impairment (IFI)
Time frame: 13 weeks
Index of Functional Impairment (IFI)
Time frame: 24 weeks
Index of Functional Impairment (IFI)
Time frame: 36 weeks
Treatment Credibility Questionnaire
Time frame: 13 weeks
Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS)
Time frame: 13 weeks
Mini International Neuropsychiatric Interview (M.I.N.I.)
Time frame: Baseline
Mini International Neuropsychiatric Interview (M.I.N.I.)
Time frame: 36 weeks
Alcohol Use Disorder Identification Test (AUDIT)
Time frame: Baseline
Alcohol Use Disorder Identification Test (AUDIT)
Time frame: 13 weeks
Alcohol Use Disorder Identification Test (AUDIT)
Time frame: 24 weeks
Alcohol Use Disorder Identification Test (AUDIT)
Time frame: 36 weeks
Drug Abuse Screening Test (DAST-10)
Time frame: Baseline
Drug Abuse Screening Test (DAST-10)
Time frame: 13 weeks
Drug Abuse Screening Test (DAST-10)
Time frame: 24 weeks
Drug Abuse Screening Test (DAST-10)
Time frame: 36 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 13 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 24 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 36 weeks
Sexual Assault Related Mental Contamination Scale (SARA)
Time frame: Baseline
Sexual Assault Related Mental Contamination Scale (SARA)
Time frame: 13 weeks
Sexual Assault Related Mental Contamination Scale (SARA)
Time frame: 24 weeks
Sexual Assault Related Mental Contamination Scale (SARA)
Time frame: 36 weeks
Beck Depression Inventory - II (BDI-II)
Time frame: Baseline
Beck Depression Inventory - II (BDI-II)
Time frame: 13 weeks
Beck Depression Inventory - II (BDI-II)
Time frame: 24 weeks
Beck Depression Inventory - II (BDI-II)
Time frame: 36 weeks
PTSD Checklist, 5th Version (PCL-5)
Time frame: Baseline
PTSD Checklist, 5th Version (PCL-5)
Time frame: 13 weeks
PTSD Checklist, 5th Version (PCL-5)
Time frame: 24 weeks
PTSD Checklist, 5th Version (PCL-5)
Time frame: 36 weeks
Clinical Administrated PTSD Scale (CAPS)
Time frame: Baseline
Clinical Administrated PTSD Scale (CAPS)
Time frame: 13 weeks
Clinical Administrated PTSD Scale (CAPS)
Time frame: 24 weeks
Clinical Administrated PTSD Scale (CAPS)
Time frame: 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Derived from this study: PubMed 34391978Acierno 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald E Acierno, PhD principal investigator
Ralph H. Johnson VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PE in people with PTSD and Stress Disorders, Post - Traumatic, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02417025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.