Circadian Influence on Prolonged Exposure Therapy for PTSD
Key facts
- Who runs it
- Massachusetts General Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Active, not recruiting
- People taking part
- 29 people enrolled
- Started
- 1 Jul 2022
- Expected to end
- 1 Sept 2027
- Type of study
- Interventional, 2 groups
- Treatments tested
- Prolonged Exposure Therapy for Posttraumatic Stress Disorder
- Record updated
- 12 November 2026
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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)
- interest in starting a course of PE
- 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
- Age range of 18-70
- A Morningness-Eveningness Questionnaire (MEQ) score above 25
- Non-exclusionary psychotropic medications must have been stable for 3 weeks prior to Screening/Assessment with intention to remain stable throughout participation
Who cannot take part
- current participation in trauma-focused cognitive-behavioral therapy (e.g., Cognitive Processing Therapy, Written Exposure Therapy, Eye Movement Desensitization and Reprocessing Therapy)
- 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
- methadone or suboxone maintenance therapy for past opioid addiction
- current or past history of bipolar I disorder, schizophrenic or other psychotic disorders,
- current organic brain disorder including moderate to severe traumatic brain injury
- factitious disorder or malingering
- current moderate or severe substance use disorder with symptoms present within the past three months
- 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
- 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
- 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
- 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.]
- active risk of harm to self or others
- having no memory of their traumatic event
- daily use of benzodiazepines
- 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
Where in United States
- VA Boston Healthcare SystemBoston, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Early morning PETreatment being tested
26 participants randomized to 10 weekly PE sessions in early morning (between 07:00-10:00) with homework exposures occurring occur at this same time of day.
Treatment: Prolonged Exposure Therapy for Posttraumatic Stress Disorder
- Late afternoon PETreatment being tested
26 participants randomized to 10 weekly PE sessions in late afternoon (16:00 or later) with homework exposures occurring occur at this same time of day.
Treatment: Prolonged Exposure Therapy for Posttraumatic Stress Disorder
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Circadian Influence on Fear Extinction Resulting From Prolonged Exposure Therapy for PTSD
- Record updated
- 12 November 2026