- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05453162
Circadian Influence on Prolonged Exposure Therapy for PTSD
February 25, 2023 updated by: Edward F. Pace-Schott, Massachusetts General Hospital
Circadian Influence on Fear Extinction Resulting From Prolonged Exposure Therapy for PTSD
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 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.
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 group and between 16:00 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 (15:00-17:00).
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 Type
Interventional
Enrollment (Anticipated)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02130-4817
- Recruiting
- VA Boston Healthcare System
-
Contact:
- Suzanne Pineles, PhD
- Email: suzanne.pineles@va.gov
-
Contact:
- Christopher McGrory, BA
- Email: christopher.mcgrory@va.gov
-
-
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.
Eligibility Criteria
Ages Eligible for Study
25 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- a diagnosis of PTSD as defined by DSM-5, with a minimum CAPS severity score of 26
- 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 25-45
- Veteran
- Intermediate ("neither type") score of 42-58 on the Morningness-Eveningness Questionnaire (MEQ).
Exclusion Criteria:
- 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
- pregnancy
- current substance use disorder
- active risk of harm to self or others
- 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
- 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)
- having no memory of their traumatic event
- daily, or as-needed, use of benzodiazepines.
- methadone or suboxone maintenance therapy for past opioid addiction
- 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.
- 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
- Non-exclusionary psychotropic medications must have been stable for 3 months prior to enrollment and remain stable throughout participation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Early morning PE
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.
|
Manualized procedures deliver ten 90-minute sessions targeted to occur weekly and administered via tele-health with the same study therapist.
Session 1 will focus on psychoeducation.
Session 2 involves construction of the in vivo exposure hierarchy.
Sessions 3-10 focus on in-session imaginal exposures to the worst trauma memory for 45-60 min followed by 15-20 min of processing the imaginal exposure.
For homework, participants will be instructed to confront situations on their hierarchy on a daily basis using recording of their imaginal exposure.
Subjective Units of Distress (SUDS) ratings will be taken throughout imaginal exposure exercises.
|
Experimental: Late afternoon PE
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.
|
Manualized procedures deliver ten 90-minute sessions targeted to occur weekly and administered via tele-health with the same study therapist.
Session 1 will focus on psychoeducation.
Session 2 involves construction of the in vivo exposure hierarchy.
Sessions 3-10 focus on in-session imaginal exposures to the worst trauma memory for 45-60 min followed by 15-20 min of processing the imaginal exposure.
For homework, participants will be instructed to confront situations on their hierarchy on a daily basis using recording of their imaginal exposure.
Subjective Units of Distress (SUDS) ratings will be taken throughout imaginal exposure exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychophysiological reactivity to script-driven imagery (SDI-PR): Primary Mechanistic Outcome
Time Frame: Between days -7 to -1, Baseline
|
This primary mechanistic outcome is a unitary discriminant canonical variable measuring psychophysiological reactivity while listening to personalized recorded scripts describing an index trauma.
|
Between days -7 to -1, Baseline
|
Psychophysiological reactivity to script-driven imagery (SDI-PR): Primary Mechanistic Outcome
Time Frame: Between days 29-34, mid-treatment
|
This primary mechanistic outcome is a unitary discriminant canonical variable measuring psychophysiological reactivity while listening to personalized recorded scripts describing an index trauma.
|
Between days 29-34, mid-treatment
|
Psychophysiological reactivity to script-driven imagery (SDI-PR: )Primary Mechanistic Outcome
Time Frame: Between days 64-71, post-treatment
|
This primary mechanistic outcome is a unitary discriminant canonical variable measuring psychophysiological reactivity while listening to personalized recorded scripts describing an index trauma.
|
Between days 64-71, post-treatment
|
Clinician-Administered PTSD scale for Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition (CAPS-5): Primary Clinical Outcome
Time Frame: Between days -7 to -1, Baseline
|
This primary clinical outcome is the gold standard clinical interview for assessing PTSD severity.
In CAPS-5, each of the 20 symptoms of PTSD is rated on a 5-point severity scale ranging from 0 (absent) to 4 (extreme).
Total scores range from 0 to 80.
|
Between days -7 to -1, Baseline
|
CAPS-5: Primary Clinical Outcome
Time Frame: Between days 29-34, mid-treatment
|
This primary clinical outcome is the gold standard clinical interview for assessing PTSD severity.
In CAPS-5, each of the 20 symptoms of PTSD is rated on a 5-point severity scale ranging from 0 (absent) to 4 (extreme).
Total scores range from 0 to 80.
|
Between days 29-34, mid-treatment
|
CAPS-5: Primary Clinical Outcome
Time Frame: Between days 64-71, post-treatment
|
This primary clinical outcome is the gold standard clinical interview for assessing PTSD severity.
In CAPS-5, each of the 20 symptoms of PTSD is rated on a 5-point severity scale ranging from 0 (absent) to 4 (extreme).
Total scores range from 0 to 80.
|
Between days 64-71, post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective Units of Distress (SUDS): Secondary Mechanistic Outcome
Time Frame: Day 14 Peak SUDS during PE therapy session 3
|
A rating scale from 0 to 100 where zero represents no distress at all and 100 represents very extreme distress, fear, or anxiety.
SUDS ratings are subjective and different individuals may rate the same situation differently.
An individual anchors their own ratings with personal recollection of situations considered "No Distress" to "Moderate" to "Extreme Distress".
|
Day 14 Peak SUDS during PE therapy session 3
|
SUDS: Secondary Mechanistic Outcome
Time Frame: Day 21 Peak SUDS during PE therapy session 4
|
A rating scale from 0 to 100 where zero represents no distress at all and 100 represents very extreme distress, fear, or anxiety.
SUDS ratings are subjective and different individuals may rate the same situation differently.
An individual anchors their own ratings with personal recollection of situations considered "No Distress" to "Moderate" to "Extreme Distress".
|
Day 21 Peak SUDS during PE therapy session 4
|
SUDS: Secondary Mechanistic Outcome
Time Frame: Day 28 Peak SUDS during PE therapy session 5
|
A rating scale from 0 to 100 where zero represents no distress at all and 100 represents very extreme distress, fear, or anxiety.
SUDS ratings are subjective and different individuals may rate the same situation differently.
An individual anchors their own ratings with personal recollection of situations considered "No Distress" to "Moderate" to "Extreme Distress".
|
Day 28 Peak SUDS during PE therapy session 5
|
SUDS: Secondary Mechanistic Outcome
Time Frame: Day 35 Peak SUDS during PE therapy session 6
|
A rating scale from 0 to 100 where zero represents no distress at all and 100 represents very extreme distress, fear, or anxiety.
SUDS ratings are subjective and different individuals may rate the same situation differently.
An individual anchors their own ratings with personal recollection of situations considered "No Distress" to "Moderate" to "Extreme Distress".
|
Day 35 Peak SUDS during PE therapy session 6
|
SUDS: Secondary Mechanistic Outcome
Time Frame: Day 42 Peak SUDS during PE therapy session 7
|
A rating scale from 0 to 100 where zero represents no distress at all and 100 represents very extreme distress, fear, or anxiety.
SUDS ratings are subjective and different individuals may rate the same situation differently.
An individual anchors their own ratings with personal recollection of situations considered "No Distress" to "Moderate" to "Extreme Distress".
|
Day 42 Peak SUDS during PE therapy session 7
|
SUDS: Secondary Mechanistic Outcome
Time Frame: Day 49 Peak SUDS during PE therapy session 8
|
A rating scale from 0 to 100 where zero represents no distress at all and 100 represents very extreme distress, fear, or anxiety.
SUDS ratings are subjective and different individuals may rate the same situation differently.
An individual anchors their own ratings with personal recollection of situations considered "No Distress" to "Moderate" to "Extreme Distress".
|
Day 49 Peak SUDS during PE therapy session 8
|
SUDS: Secondary Mechanistic Outcome
Time Frame: Day 56 Peak SUDS during PE therapy session 9
|
A rating scale from 0 to 100 where zero represents no distress at all and 100 represents very extreme distress, fear, or anxiety.
SUDS ratings are subjective and different individuals may rate the same situation differently.
An individual anchors their own ratings with personal recollection of situations considered "No Distress" to "Moderate" to "Extreme Distress".
|
Day 56 Peak SUDS during PE therapy session 9
|
SUDS: Secondary Mechanistic Outcome
Time Frame: Day 63 Peak SUDS during PE therapy session 10
|
A rating scale from 0 to 100 where zero represents no distress at all and 100 represents very extreme distress, fear, or anxiety.
SUDS ratings are subjective and different individuals may rate the same situation differently.
An individual anchors their own ratings with personal recollection of situations considered "No Distress" to "Moderate" to "Extreme Distress".
|
Day 63 Peak SUDS during PE therapy session 10
|
PCL-5: PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM), Fifth Edition: Secondary Clinical Outcome
Time Frame: Day 0 PCL-5 score at PE therapy session 1
|
Self-ratings of how much one is bothered by each of the 20 symptoms of PTSD on a 5-point severity scale ranging from 0 (Not at all) to 4 (extremely).
|
Day 0 PCL-5 score at PE therapy session 1
|
PCL-5: Secondary Clinical Outcome
Time Frame: Day 7 PCL-5 score at PE therapy session 2
|
Self-ratings of how much one is bothered by each of the 20 symptoms of PTSD on a 5-point severity scale ranging from 0 (Not at all) to 4 (extremely).
|
Day 7 PCL-5 score at PE therapy session 2
|
PCL-5: Secondary Clinical Outcome
Time Frame: Day 14 PCL-5 score at PE therapy session 3
|
Self-ratings of how much one is bothered by each of the 20 symptoms of PTSD on a 5-point severity scale ranging from 0 (Not at all) to 4 (extremely).
|
Day 14 PCL-5 score at PE therapy session 3
|
PCL-5: Secondary Clinical Outcome
Time Frame: Day 21 PCL-5 score at PE therapy session 4
|
Self-ratings of how much one is bothered by each of the 20 symptoms of PTSD on a 5-point severity scale ranging from 0 (Not at all) to 4 (extremely).
|
Day 21 PCL-5 score at PE therapy session 4
|
PCL-5: Secondary Clinical Outcome
Time Frame: Day 28 PCL-5 score at PE therapy session 5
|
Self-ratings of how much one is bothered by each of the 20 symptoms of PTSD on a 5-point severity scale ranging from 0 (Not at all) to 4 (extremely).
|
Day 28 PCL-5 score at PE therapy session 5
|
PCL-5: Secondary Clinical Outcome
Time Frame: Day 35 PCL-5 score at PE therapy session 6
|
Self-ratings of how much one is bothered by each of the 20 symptoms of PTSD on a 5-point severity scale ranging from 0 (Not at all) to 4 (extremely).
|
Day 35 PCL-5 score at PE therapy session 6
|
PCL-5: Secondary Clinical Outcome
Time Frame: Day 42 PCL-5 score at PE therapy session 7
|
Self-ratings of how much one is bothered by each of the 20 symptoms of PTSD on a 5-point severity scale ranging from 0 (Not at all) to 4 (extremely).
|
Day 42 PCL-5 score at PE therapy session 7
|
PCL-5: Secondary Clinical Outcome
Time Frame: Day 49 PCL-5 score at PE therapy session 8
|
Self-ratings of how much one is bothered by each of the 20 symptoms of PTSD on a 5-point severity scale ranging from 0 (Not at all) to 4 (extremely).
|
Day 49 PCL-5 score at PE therapy session 8
|
PCL-5: Secondary Clinical Outcome
Time Frame: Day 56 PCL-5 score at PE therapy session 9
|
Self-ratings of how much one is bothered by each of the 20 symptoms of PTSD on a 5-point severity scale ranging from 0 (Not at all) to 4 (extremely).
|
Day 56 PCL-5 score at PE therapy session 9
|
PCL-5: Secondary Clinical Outcome
Time Frame: Day 63 PCL-5 score at PE therapy session 10
|
Self-ratings of how much one is bothered by each of the 20 symptoms of PTSD on a 5-point severity scale ranging from 0 (Not at all) to 4 (extremely).
|
Day 63 PCL-5 score at PE therapy session 10
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Salivary cortisol
Time Frame: Between days -7 to -1, baseline
|
Concentration in saliva sample obtained by passive drool and analyzed by enzyme immunoassay
|
Between days -7 to -1, baseline
|
Salivary cortisol
Time Frame: Day 0, therapy session 1
|
Concentration in saliva sample obtained by passive drool and analyzed by enzyme immunoassay
|
Day 0, therapy session 1
|
Salivary cortisol
Time Frame: Day 7, therapy session 2
|
Concentration in saliva sample obtained by passive drool and analyzed by enzyme immunoassay
|
Day 7, therapy session 2
|
Salivary cortisol
Time Frame: Day 14, therapy session 3
|
Concentration in saliva sample obtained by passive drool and analyzed by enzyme immunoassay
|
Day 14, therapy session 3
|
Salivary cortisol
Time Frame: Day 21, therapy session 4
|
Concentration in saliva sample obtained by passive drool and analyzed by enzyme immunoassay
|
Day 21, therapy session 4
|
Salivary cortisol
Time Frame: Day 28, therapy session 5
|
Concentration in saliva sample obtained by passive drool and analyzed by enzyme immunoassay
|
Day 28, therapy session 5
|
Salivary cortisol
Time Frame: Between days 29-34, mid-treatment assessment
|
Concentration in saliva sample obtained by passive drool and analyzed by enzyme immunoassay
|
Between days 29-34, mid-treatment assessment
|
Salivary cortisol
Time Frame: Day 35, therapy session 6
|
Concentration in saliva sample obtained by passive drool and analyzed by enzyme immunoassay
|
Day 35, therapy session 6
|
Salivary cortisol
Time Frame: Day 42, therapy session 7
|
Concentration in saliva sample obtained by passive drool and analyzed by enzyme immunoassay
|
Day 42, therapy session 7
|
Salivary cortisol
Time Frame: Day 49, therapy session 8
|
Concentration in saliva sample obtained by passive drool and analyzed by enzyme immunoassay
|
Day 49, therapy session 8
|
Salivary cortisol
Time Frame: Day 56, therapy session 9
|
Concentration in saliva sample obtained by passive drool and analyzed by enzyme immunoassay
|
Day 56, therapy session 9
|
Salivary cortisol
Time Frame: Day 63, therapy session 10
|
Concentration in saliva sample obtained by passive drool and analyzed by enzyme immunoassay
|
Day 63, therapy session 10
|
Salivary cortisol
Time Frame: Between days 64-71, post-treatment
|
Concentration in saliva sample obtained by passive drool and analyzed by enzyme immunoassay
|
Between days 64-71, post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pace-Schott EF, Germain A, Milad MR. Effects of sleep on memory for conditioned fear and fear extinction. Psychol Bull. 2015 Jul;141(4):835-57. doi: 10.1037/bul0000014. Epub 2015 Apr 20.
- Pace-Schott EF, Germain A, Milad MR. Sleep and REM sleep disturbance in the pathophysiology of PTSD: the role of extinction memory. Biol Mood Anxiety Disord. 2015 May 29;5:3. doi: 10.1186/s13587-015-0018-9. eCollection 2015.
- Meuret AE, Rosenfield D, Bhaskara L, Auchus R, Liberzon I, Ritz T, Abelson JL. Timing matters: Endogenous cortisol mediates benefits from early-day psychotherapy. Psychoneuroendocrinology. 2016 Dec;74:197-202. doi: 10.1016/j.psyneuen.2016.09.008. Epub 2016 Sep 15.
- Meuret AE, Trueba AF, Abelson JL, Liberzon I, Auchus R, Bhaskara L, Ritz T, Rosenfield D. High cortisol awakening response and cortisol levels moderate exposure-based psychotherapy success. Psychoneuroendocrinology. 2015 Jan;51:331-40. doi: 10.1016/j.psyneuen.2014.10.008. Epub 2014 Oct 16.
- Pace-Schott EF, Spencer RM, Vijayakumar S, Ahmed NA, Verga PW, Orr SP, Pitman RK, Milad MR. Extinction of conditioned fear is better learned and recalled in the morning than in the evening. J Psychiatr Res. 2013 Nov;47(11):1776-84. doi: 10.1016/j.jpsychires.2013.07.027. Epub 2013 Aug 28.
- Brueckner AH, Lass-Hennemann J, Wilhelm FH, Ferreira de Sa DS, Michael T. Cortisol administration after extinction in a fear-conditioning paradigm with traumatic film clips prevents return of fear. Transl Psychiatry. 2019 Apr 8;9(1):128. doi: 10.1038/s41398-019-0455-0.
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 Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Anticipated)
April 30, 2024
Study Completion (Anticipated)
April 30, 2024
Study Registration Dates
First Submitted
June 29, 2022
First Submitted That Met QC Criteria
July 6, 2022
First Posted (Actual)
July 12, 2022
Study Record Updates
Last Update Posted (Estimate)
February 28, 2023
Last Update Submitted That Met QC Criteria
February 25, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021p003356
- R21MH128619 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
We will share data every January 15 and July 15 with the NIMH Data Archives (NDA) under a NIMH Data Repositories Data Submission Agreement between NIMH and VA Boston Health System (VABHS).
Data sharing is required for all NIMH-funded research projects.
The NDA DSA will be approved by the VABHS IRB.
Each participant will be assigned Global Unique ID (GUID) and data shared will contain no identifiable information.
Shared data will include scored psychophysiological, self-report instruments, cortisol, actigraphy, and fully de-identified demographic data.
IPD Sharing Time Frame
Study data will become available following the end of the study and the publication of results.
IPD Sharing Access Criteria
Investigators can apply to the NIMH Data Archive (NDA) for permission to use these data.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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