Ignite Creation Date:
2024-05-06 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03533608
Status:
COMPLETED
Last Update Posted:
2023-07-25
First Post:
2018-05-10
Brief Title:
Optimizing Treatment Response in VA Specialized IntensiveInpatient PTSD Programs
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Pilot Study of Group Prolonged Exposure in Residential Treatment CDA 15-251
Status:
COMPLETED
Status Verified Date:
2023-07
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:
Prolonged Exposure therapy PE is a first-line treatment for posttraumatic stress disorder however few VA patients receive this treatment One of the barriers to PE receipt is that this treatment is only available in an individual one-on-one format whereas many VA mental health clinics provide the majority of their psychotherapy services in group format In particular PTSD residential rehabilitation programs RRTPs offer most programming in group format Thus the current study was designed to pilot test a group format of PE in RRTPs
Detailed Description:
Fifty Veterans who are currently receiving treatment in the PTSD RRTP at a Midwest VA will be recruited to participate in a Group PE protocol Participants will engage in 12 90-minute sessions of Group PE over the course of 6 weeks Treatment consists of psychoeducation rationale for treatment and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms PTSD symptoms will be measured via the PCL-5 The goal of this pilot study will be to determine whether or not it will be feasible to conduct a full-scale trial of Group PE in the current setting by testing the process resources management and scientific basis of the planned trial As such the proposed study will primarily assess feasibility outcomes and not efficacy outcomes The investigators will assess number of participants screened number meeting inclusion criteria adherence of participants to the proposed treatment measured via number of sessions attended standard deviation of the outcome measure PCL-5 response rates to questionnaires and loss to follow-up The investigators will also measure clinicians adherence to protocol and acceptability of the treatment to patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDA 15-251 | OTHER_GRANT | Dept of Veterans Affairs HSRD | None |