Circadian Influence on Prolonged Exposure Therapy for PTSD

Description

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 07:00 to a time no later than 2 hours past a participant's customary rise time, or to the last treatment session of the day beginning at 16:00 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, i.e., within 2 hours of awakening for morning (AM) group and between 16:00 and 2 hours before bedtime for late afternoon (PM) group.

Conditions

PTSD

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Study Overview

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Study Details

Study overview

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 07:00 to a time no later than 2 hours past a participant's customary rise time, or to the last treatment session of the day beginning at 16:00 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, i.e., within 2 hours of awakening for morning (AM) group and between 16:00 and 2 hours before bedtime for late afternoon (PM) group.

Circadian Influence on Fear Extinction Resulting From Prolonged Exposure Therapy for PTSD

Circadian Influence on Prolonged Exposure Therapy for PTSD

Condition
PTSD
Intervention / Treatment

-

Contacts and Locations

Boston

VA Boston Healthcare System, Boston, Massachusetts, United States, 02130-4817

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. a diagnosis of PTSD as defined by DSM-5, with a minimum CAPS severity score of 26
  • 2. interest in starting a course of PE
  • 3. availability for appointments at that will either begin from 07:00 to a time no longer than 2 hours past their customary rise time, or to the last treatment session of the day beginning at 16:00 or later
  • 4. Age range of 25-45
  • 5. Veteran
  • 6. Intermediate ("neither type") score of 42-58 on the Morningness-Eveningness Questionnaire (MEQ).
  • 1. current or past history of bipolar I disorder, schizophrenic or other psychotic disorders,
  • 2. current organic brain disorder including moderate to severe traumatic brain injury
  • 3. factitious disorder or malingering
  • 4. pregnancy
  • 5. current substance use disorder
  • 6. active risk of harm to self or others
  • 7. evidence of clinically significant hepatic or renal disease or any other acute or unstable medical condition that might interfere with safe conduct of the study
  • 8. current participation in trauma-focused cognitive-behavioral therapy (e.g., Cognitive Processing Therapy, Written Exposure Therapy, Eye Movement Desensitization and Reprocessing Therapy)
  • 9. prior treatment with an adequate dose of PE (i.e., 8 or more sessions)
  • 10. having no memory of their traumatic event
  • 11. daily, or as-needed, use of benzodiazepines.
  • 12. methadone or suboxone maintenance therapy for past opioid addiction
  • 13. diagnosis of Cushing's disease, Addison's disease or use of medications that target cortisol directly such as those used to treat Cushing's disease \[ketoconazole, mitotane (Lysodren), metyrapone (Metopirone), and Mifepristone (Korlym, Mifeprex)\], those used to treat Addison's disease \[Hydrocortisone (Cortef), prednisone or methylprednisolone\], as well as cortisone or dexamethasone.
  • 14. persons habitually waking up after 8 AM or who would habitually awaken so early that more than 2 h would elapse before a morning PE session could occur
  • 15. Non-exclusionary psychotropic medications must have been stable for 3 months prior to enrollment and remain stable throughout participation.

Ages Eligible for Study

25 Years to 45 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Edward F Pace-Schott, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Suzanne L Pineles, PhD, PRINCIPAL_INVESTIGATOR, VA Boston Health System, Boston University

Study Record Dates

2024-04-30