ACTIVE_NOT_RECRUITING

Circadian Influence on Prolonged Exposure Therapy for PTSD

Conditions

PTSD Circadian Exposure Therapy Sleep Cortisol

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-07-01

Study Completion:2025-08-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05453162

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.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. a diagnosis of PTSD as defined by DSM-5, with a minimum CAPS severity score of 26, a minimum PCL-5 score of 31, or a score of 2 or above on CAPS-5 Item B2 (concerning distressing dreams) 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 18-70 5. A Morningness-Eveningness Questionnaire (MEQ) score above 25. 6. Non-exclusionary psychotropic medications must have been stable for 3 weeks prior to Screening/Assessment with intention to remain stable throughout participation.	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. pregnant or planning to become pregnant in the next four months at time of screening \[if a participant does become pregnant during study procedures, the situation will be reviewed on a case-by-case basis and the participant's wishes will be considered in deciding whether the participant will continue with the study or withdraw.\] 5. current moderate or severe substance use disorder with symptoms present within the past three months 6. diagnosed moderate to severe sleep apnea, narcolepsy, periodic limb movement, or restless legs syndrome that result in daytime sleepiness indicated by Epworth Sleepiness Scale (ESS) above 10 7. active risk of harm to self or others 8. 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 9. current participation in trauma-focused cognitive-behavioral therapy (e.g., Cognitive Processing Therapy, Written Exposure Therapy, Eye Movement Desensitization and Reprocessing Therapy) 10. prior treatment with an adequate dose of PE (i.e., 8 or more sessions) to the traumatic event that would be the index trauma for treatment in the study 11. having no memory of their traumatic event 12. daily use of benzodiazepines 13. methadone or suboxone maintenance therapy for past opioid addiction 14. 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. 15. persons who would habitually awaken so early that more than 2 h would elapse before a morning PE session could occur; or those who engage in habitual shiftwork or transmeridian travel

Inclusion Criteria

Exclusion Criteria

1. a diagnosis of PTSD as defined by DSM-5, with a minimum CAPS severity score of 26, a minimum PCL-5 score of 31, or a score of 2 or above on CAPS-5 Item B2 (concerning distressing dreams)
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 18-70
5. A Morningness-Eveningness Questionnaire (MEQ) score above 25.
6. Non-exclusionary psychotropic medications must have been stable for 3 weeks prior to Screening/Assessment with intention to remain stable throughout participation.

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. pregnant or planning to become pregnant in the next four months at time of screening \[if a participant does become pregnant during study procedures, the situation will be reviewed on a case-by-case basis and the participant's wishes will be considered in deciding whether the participant will continue with the study or withdraw.\]
5. current moderate or severe substance use disorder with symptoms present within the past three months
6. diagnosed moderate to severe sleep apnea, narcolepsy, periodic limb movement, or restless legs syndrome that result in daytime sleepiness indicated by Epworth Sleepiness Scale (ESS) above 10
7. active risk of harm to self or others
8. 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
9. current participation in trauma-focused cognitive-behavioral therapy (e.g., Cognitive Processing Therapy, Written Exposure Therapy, Eye Movement Desensitization and Reprocessing Therapy)
10. prior treatment with an adequate dose of PE (i.e., 8 or more sessions) to the traumatic event that would be the index trauma for treatment in the study
11. having no memory of their traumatic event
12. daily use of benzodiazepines
13. methadone or suboxone maintenance therapy for past opioid addiction
14. 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.
15. persons who would habitually awaken so early that more than 2 h would elapse before a morning PE session could occur; or those who engage in habitual shiftwork or transmeridian travel

Contacts and Locations

Principal Investigator

Edward F Pace-Schott, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Suzanne L Pineles, PhD

PRINCIPAL_INVESTIGATOR

VA Boston Health System, Boston University

Study Locations (Sites)

VA Boston Healthcare System

Boston, Massachusetts, 02130-4817

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-01

Study Completion Date2025-08-15

Study Record Updates

Study Start Date2022-07-01

Study Completion Date2025-08-15

Terms related to this study

Keywords Provided by Researchers

PTSD
Circadian
Exposure Therapy
Sleep
Cortisol

Additional Relevant MeSH Terms

PTSD