Ignite Creation Date:
2024-05-06 @ 5:51 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05453162
Status:
RECRUITING
Last Update Posted:
2023-02-28
First Post:
2022-06-29
Brief Title:
Circadian Influence on Prolonged Exposure Therapy for PTSD
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Circadian Influence on Fear Extinction Resulting From Prolonged Exposure Therapy for PTSD
Status:
RECRUITING
Status Verified Date:
2023-02
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:
Proposed research will examine time-of-day effects on trauma-related fear extinction using Prolonged Exposure Therapy PE telemedicine for Posttraumatic Stress Disorder PTSD in the National Center for PTSD NCPTSD The primary mechanistic outcome measure will be change in psychophysiological reactivity to script-driven imagery SDI-PR measured in person at pre-treatment after 5 PE sessions mid-treatment and after all 10 PE sessions post-treatment A secondary mechanistic outcome will be session-to-session reduction in peak subjective units of distress SUDS ratings to imaginal exposures The primary clinical outcome will be change in Clinican Administered PTSD Scale CAPS-5 severity score a secondary clinical outcome will be session-to-session reduction in self-reported PTSD symptoms using the PTSD checklist PCL-5 Participants meeting inclusion criteria described below will be randomized to either PE sessions that begin from 0700 to a time no later than 2 hours past a participants customary rise time or to the last treatment session of the day beginning at 1600 or later 26 per arm Participants will complete daily at-home imaginal-exposure homework within the same time frame as their PE sessions are scheduled ie within 2 hours of awakening for morning AM group and between 1600 and 2 hours before bedtime for late afternoon PM group
Detailed Description:
Proposed research will examine time-of-day effects on trauma-related fear extinction using PE therapy for PTSD in the National Center for PTSD NCPTSD The primary mechanistic outcome measure will be change in SDI-PR a secondary mechanistic outcome will be session-to-session reduction in peak SUDS ratings to imaginal exposures The primary clinical outcome will be change in CAPS-5 severity score a secondary clinical outcome will be session-to-session reduction in self-reported PTSD symptoms PCL-5 Participants meeting inclusion criteria described below will be randomized to either PE sessions that begin from 0700 to a time no later than 2 hours past a participants customary rise time or to the last treatment session of the day beginning at 1600 or later Participants will complete daily at-home imaginal-exposure homework within the same time frame as their PE sessions are scheduled ie within 2 hours of awakening for morning group and between 1600 and 2 hours before bedtime for late afternoon group The assessment schedule will be identical for all participants Participants who meet study inclusion criteria at screening will first begin a 7-day pre-study sleep-monitoring period with wrist actigraphy sleep diaries and completion of a diurnal profile of salivary cortisol levels Trauma-related fear will be assessed using the standard SDI procedures detailed below at pre-treatment after 5 PE sessions mid-treatment and after all 10 PE sessions post-treatment The CAPS-5 will be administered at these same times PCL-5 measurements will be obtained at each treatment session and SUDs will be obtained during all treatment sessions that include imaginal exposure sessions 3-8 All SDI sessions will be carried out at a standardized time of day in the late-afternoon 1500-1700 PE treatment will be administered at a targeted rate of once per week At each PE and assessment session pre-session saliva samples will be obtained for cortisol measurement and normalized using the diurnal profile of cortisol obtained during the sleep-assessment week Participants will wear the wrist actigraph and complete sleep diaries throughout PE The diurnal cortisol profile will be repeated at the post-treatment assessment
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21MH128619 | NIH | None | httpsreporternihgovquickSearchR21MH128619 |