Ignite Creation Date:
2024-05-06 @ 3:16 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02246972
Status:
COMPLETED
Last Update Posted:
2017-08-09
First Post:
2014-09-19
Brief Title:
BraveMind Advancing the Virtual IraqAfghanistan PTSD Exposure Therapy
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
BRAVEMIND Advancing the Virtual IraqAfghanistan PTSD Exposure Therapy System for MST
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study is designed to test the clinical efficacy of the BRAVEMIND military sexual trauma MST system in an initial feasibility and wait list clinical trial of 45 users
The following hypotheses will be tested
1 Virtual Reality Exposure Therapy VRET will be safely deliverable to persons with posttraumatic stress disorder PTSD due to MST as evidenced by treatment dropout rates that are similar to existing Prolonged Exposure PE therapy delivered in military samples 20-40 and by the absence of any critical incidents
2 Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression PTSD Checklist-Military PCL-M Clinician Administered PTSD Scale CAPS and Patient Health Questionnaire PHQ-9 scores and psychophysiological measures following treatment
3 Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression PCL-M CAPS PHQ-9 scores and psychophysiological measures compared to wait-list results
The following hypotheses will be tested
1 Virtual Reality Exposure Therapy VRET will be safely deliverable to persons with posttraumatic stress disorder PTSD due to MST as evidenced by treatment dropout rates that are similar to existing Prolonged Exposure PE therapy delivered in military samples 20-40 and by the absence of any critical incidents
2 Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression PTSD Checklist-Military PCL-M Clinician Administered PTSD Scale CAPS and Patient Health Questionnaire PHQ-9 scores and psychophysiological measures following treatment
3 Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression PCL-M CAPS PHQ-9 scores and psychophysiological measures compared to wait-list results
Detailed Description:
Pre-Treatment Assessment
Potential subjects will be asked to provide a copy of their DD214 to verify their military service record Once a potential participant has met all screening inclusion and exclusion criteria and consented to participate the CAPS will be administered to determine current PTSD status
Randomization
Following pre-treatment assessment patients will be randomized to receive VRET Virtual Reality Exposure Therapy immediately or wait 6 weeks during which time they will continue to receive usual care Wait-listed participants will be reassessed prior to beginning their course of treatment with the Clinician Administered PTSD Scale CAPS PTSD Checklist-Military PCL-M Beck Depression Inventory-II BDI-II and psychophysiological measures This pre-treatment assessment visit will last about 2-3 hours
Therapy
Participants will be treated once or twice per week for 6-12 sessions VRET treatment will be limited to a minimum of 6 sessions and a maximum of 12 sessions based upon reaching criterion of 70 symptom improvement as indicated on the PCL-M from baseline or an agreement between clinician and participant that maximum treatment response has been achieved All sessions will be individual and weekly or twice weekly The first session will last approximately 90 minutes and will be spent in information gathering treatment planning and explaining the treatment rationale to the patient Information gathering will review the history of PTSD and their military service and will include a brief psychosocial history including review of prior treatment
Session 2 will discuss in vivo exposure and construct the hierarchy for in vivo exposure The VRET sessions will last 90 minutes each During VRET sessions patients will wear a head-mounted display with stereo earphones that will provide visual and audio cues consistent with Iraqi or Afghan military scenarios or other base-related scenarios as appropriate for the individual patient The therapist will make appropriate comments and encourage continued exposure to the identified index trauma until anxiety has habituated During exposure information will be gathered on the participants anxiety level through the use of a 0-100 Subjective Units of Discomfort SUDs scale All therapists will have been trained in Prolonged Imaginal Exposure therapy PE followed by training in VRET by Drs Rothbaum and Gerardi Drs Rothbaum and Gerardi will supervise all therapy
Potential subjects will be asked to provide a copy of their DD214 to verify their military service record Once a potential participant has met all screening inclusion and exclusion criteria and consented to participate the CAPS will be administered to determine current PTSD status
Randomization
Following pre-treatment assessment patients will be randomized to receive VRET Virtual Reality Exposure Therapy immediately or wait 6 weeks during which time they will continue to receive usual care Wait-listed participants will be reassessed prior to beginning their course of treatment with the Clinician Administered PTSD Scale CAPS PTSD Checklist-Military PCL-M Beck Depression Inventory-II BDI-II and psychophysiological measures This pre-treatment assessment visit will last about 2-3 hours
Therapy
Participants will be treated once or twice per week for 6-12 sessions VRET treatment will be limited to a minimum of 6 sessions and a maximum of 12 sessions based upon reaching criterion of 70 symptom improvement as indicated on the PCL-M from baseline or an agreement between clinician and participant that maximum treatment response has been achieved All sessions will be individual and weekly or twice weekly The first session will last approximately 90 minutes and will be spent in information gathering treatment planning and explaining the treatment rationale to the patient Information gathering will review the history of PTSD and their military service and will include a brief psychosocial history including review of prior treatment
Session 2 will discuss in vivo exposure and construct the hierarchy for in vivo exposure The VRET sessions will last 90 minutes each During VRET sessions patients will wear a head-mounted display with stereo earphones that will provide visual and audio cues consistent with Iraqi or Afghan military scenarios or other base-related scenarios as appropriate for the individual patient The therapist will make appropriate comments and encourage continued exposure to the identified index trauma until anxiety has habituated During exposure information will be gathered on the participants anxiety level through the use of a 0-100 Subjective Units of Discomfort SUDs scale All therapists will have been trained in Prolonged Imaginal Exposure therapy PE followed by training in VRET by Drs Rothbaum and Gerardi Drs Rothbaum and Gerardi will supervise all therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None