Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05889741
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2023-04-17
Brief Title:
Combining Stellate Ganglion Block With Prolonged Exposure for PTSD
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
Combining Stellate Ganglion Block With Prolonged Exposure for PTSD A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-02
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 goal of this clinical trial is to compare the combination of Massed Prolonged Exposure PE a behavioral therapy for PTSD and a stellate ganglion block SGB an injection of a local anesthetic into the front of the neck with Massed Prolonged Exposure and a sham injection in a sample of military service members or retirees with PTSD The main questions it aims to answer are 1 Does the addition of an SGB improve treatment outcomes associated with Massed PE and 2 Do differences in psychophysiological arousal during the exposure portion of treatment help explain treatment outcomes for PTSD Participants will receive ten 90-minute session of Massed PE Between the first and second Massed PE sessions half of the participants will receive a SGB and half will receive a sham SGB
Detailed Description:
Massed PE will be conducted by master-level or doctoral-level therapists Participants will meet with their providers for individual 90-minute sessions They will then be asked to complete out-of-session treatment assignments throughout the rest of the day Between the individual therapy session and out-of-session treatment assignments participants will engage in approximately four to six hours of treatment per day Monday through Friday for two weeks Each participant will also be offered three booster sessions at 1- 3- and 7-weeks posttreatment
The stellate ganglion block injection or the sham SGB will be administered between the first and second massed PE session by qualified medical personnel as per standard operating procedure for the placement of a stellate ganglion block A research nurse will be in attendance during the procedure and for an hour recovery period following the block administration
Assessments will be administered at pretreatment during treatment at posttreatment and at 1- 3- and 6-months following the completion of PE The primary outcome assessment will be 1-month following the completion of PE Following this assessment participants randomized to the sham SGB arm of the study will be offered an SGB with ropivacaine
The stellate ganglion block injection or the sham SGB will be administered between the first and second massed PE session by qualified medical personnel as per standard operating procedure for the placement of a stellate ganglion block A research nurse will be in attendance during the procedure and for an hour recovery period following the block administration
Assessments will be administered at pretreatment during treatment at posttreatment and at 1- 3- and 6-months following the completion of PE The primary outcome assessment will be 1-month following the completion of PE Following this assessment participants randomized to the sham SGB arm of the study will be offered an SGB with ropivacaine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None