Posttraumatic Stress DisorderNMNCT05195684
MGH Trauma-related Nightmares SDI Study
A study testing imaginal probe in people with Posttraumatic Stress Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Interested individuals will first complete a telephone screening followed by a series of structured clinical interviews to diagnose PTSD and comorbid psychiatric disorders, confirm initial inclusion criteria, rule out exclusion criteria and create an audio-recorded account of their index trauma. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- imaginal probe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years
- Normal or corrected to normal visual acuity, normal hearing
- Index event that meets DSM-5 PTSD stressor criterion A, viz. "The person was exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence" by direct exposure, witnessing in person, or having a close relative or friend exposed to violent or accidental actual or threatened death.
- Self-report of at least 1 nightmares per week related to the index trauma. The trauma nightmares must contain veridical (vs., symbolic, interpreted, etc.) content that is reminiscent of the index trauma.
- Individuals who meet criteria for at least three of the four DSM-5 criterion categories.
- At least one recorded nightmares related to the index trauma with at least one suitable for creating a script for SDI.
Who cannot join
- Lifetime history of psychosis, bipolar disorder, autism spectrum or other neurodevelopmental disorder, active risk to self or others
- History of sleep apnea or an apnea/hypopnea index of >15 on the diagnostic night of ambulatory PSG (i.e., 15 or more sleep apnea-hypopneas per hour of sleep)
- Neurologic conditions that could confound outcome variables, including past neurosurgical procedures, seizure, neurodegenerative disease, stroke, known structural brain lesion, significant head trauma with extended loss of consciousness and/or persistent neurological sequela (mild TBI allowed)
- Medical conditions that could confound outcome variables such as severe cardiovascular or other systemic disease
- Use of benzodiazepines, beta blockers, prazosin or antipsychotics (antidepressants or mood stabilizers with stable dose for ≥ 3 months allowed)
- Current Alcohol and Substance Use Disorder or positive urine toxicology screen for drugs of abuse
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- MRI contraindications (e.g., metal in body or eyes, pacemaker, pump, stimulator, shunt, claustrophobia, weight >250 lbs.)
- Pregnancy, breastfeeding or nursing: A pregnancy test (urine ß-HCG) will be conducted prior to the structural MRI for all women of child-bearing capacity
- Supervisees of study investigators
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
About this study
Official title: Autonomic and Fronto-cortical Correlates of Script-driven Imagery of Trauma-related Nightmares Compared With Such Imagery of Index Trauma in PTSD Using Ambulatory Physiological and fNIRS Recordings
Interested individuals will first complete a telephone screening followed by a series of structured clinical interviews to diagnose PTSD and comorbid psychiatric disorders, confirm initial inclusion criteria, rule out exclusion criteria and create an audio-recorded account of their index trauma. Participants passing screenings will then complete 2 weeks of at-home sleep and nightmare diaries and time-stamped audio-recorded reports of dream content upon awakening from any nightmare. They will also wear a wrist actigraph throughout this period, complete 2 nights of ambulatory PSG, and complete on-line questionnaires. Nightmare data will be examined for frequency and thematic similarity of nightmares to a participant's reported index trauma. Participants' nightmare and index trauma reports will be audio-recorded for use as scripts during SDI. The participant will then undergo two SDI sessions on a single day, one with a nightmare script and one with an index-trauma script, during which they will wear the NINscan. Sessions will be separated by 1 hour and counterbalanced across participants for script order.
Read the detailed description
Trauma-related nightmares (TRNs) are a hallmark re-experiencing symptom of Posttraumatic Stress Disorder (PTSD) and a severe, re-traumatizing source of distress to those with this condition. Proposed research will investigate whether such nightmares might serve as targets for imaginal exposure during prolonged exposure therapy (PE), a first-line treatment for PTSD. Learning and memory of fear extinction are the neurocognitive underpinnings of PE and increased physiological arousal during PE can aid in extinction learning. Thus, PE using TRNs might enhance treatment outcomes because of the greater immediacy and salience of nightmares relative to the more temporally distant traumatic event. Our research group has developed standardized script-driven imagery (SDI) procedures whereby the degree of psychophysiological arousal induced by recollection of the traumatic event that precipitated posttraumatic symptoms (index trauma) can be assessed. Our team has also developed a novel ambulatory device, the NINscan, that can record skin conductance (SC), facial electromyography (EMG) and electrocardiography (ECG) along with simultaneous functional near-infrared spectroscopic (fNIRS) imaging of the lateral prefrontal cortex (LPFC). The LPFC encompasses regions that activate and/or deactivate during SDI in persons with PTSD and includes the right inferior frontal gyrus (rIFG), an area that plays an important role in inhibiting unwanted behavior and cognition and shows reduced inhibitory performance in PTSD. Following screenings that include a structured clinical evaluation establishing PTSD diagnosis and self-report of a least 2 TRNs per week, qualified participants will record an account of their index trauma. They will then complete 2 weeks of sleep diaries and wrist actigraphy with 4 nights of ambulatory polysomnography (PSG), during which they will audio-record, on a time-stamped digital recorder, a detailed nightmare report following any nightmare-induced awakening. A TRN report having sufficient length, clarity and resemblance to the index trauma will be selected and, along with the index-trauma report, will be re-recorded as a script for SDI. Only participants who generated a TRN suitable for SDI (N=40) will then undergo 2 SDI sessions on a single day while wearing the NINscan. One script will be derived from their index trauma and the other from their TRN, the order of which will be counterbalanced across participants. Psychophysiological response and fNIRS LPFC activation will be compared between scripts using 2 primary outcome measures: (1) a validated canonical psychophysiological variable combining SC, EMG and ECG, and (2) script-related activation of the rIFC. We hypothesize that both activations will be greater for the TRN than for the index-trauma script. Exploratory aims will include (1) examination of the sleep stage and electroencephalographic characteristics of sleep preceding awakenings when a nightmare occurred on a night with PSG.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- imaginal probe
- Keywords
- nightmares, script driven imagery, functional near-infrared spectroscopy, psychophysiology, polysomnography, sleep
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imaginal probeOther
trauma and nightmare imaginal probe/challenge for which psychophysiological and CNS responses are recorded
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | entirely within-subject outcome variables Receives: Other: imaginal probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychophysiological difference score
"difference scores" between biosignals from the 30-s epoch of nightmare and index-trauma SDI and their baseline epochs (30s of silence preceding the respective script). Individual skin conductance, heart rate and corrugator EMG difference scores as well as composite SDI-PR score.
Measured: Immediately after the procedure.
fNIRS rlIFG difference score
O2Hb minus HHb concentrations (HbD) difference score at right lateral inferior frontal (rlIFG) Region of Interest (ROI)
Measured: Up to 24 weeks.
Secondary outcomes (1)
fNIRS difference score for remaining 7 frontolateral ROIs
O2Hb minus HHb concentrations (HbD) difference score at remaining 7 frontolateral ROIs
Measured: Up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Jun 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group study of trauma nightmares, sleep and psychophysiological and neural (fNIRS) responses to imagery of actual trauma and of trauma-related nightmares. Within-subject comparison of psychophysiological and neural responses to imagery of trauma compared to trauma-related nightmare and imagery of unrelated neutral content. Correlational study of psychophysiological and neural responses with clinical self-report measures.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward F. Pace-Schott, Massachusetts General Hospital
- Investigators
- Edward F Pace-Schott, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195684
- Sponsor's protocol ID
- 2020P001361
- Acronym
- NM
- Status last verified
- Dec 2022
- First submitted
- 15 Dec 2021
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data shared with NIMH Data Archive (NDA), NDA creates subject GUID
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic and Fronto-cortical Correlates of Script-driven Imagery of Trauma-related Nightmares Compared With Such Imagery of Index Trauma in PTSD Using Ambulatory Physiological and fNIRS Recordings
- ClinicalTrials.gov ID
- NCT05195684
- Acronym / sponsor ID
- NM / 2020P001361
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- nightmares, script driven imagery, functional near-infrared spectroscopy, psychophysiology, polysomnography, sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interested individuals will first complete a telephone screening followed by a series of structured clinical interviews to diagnose PTSD and comorbid psychiatric disorders, confirm initial inclusion criteria, rule out exclusion criteria and create an audio-recorded account of their index trauma. Participants passing screenings will then complete 2 weeks of at-home sleep and nightmare diaries and time-stamped audio-recorded reports of dream content upon awakening from any nightmare. They will also wear a wrist actigraph throughout this period, complete 2 nights of ambulatory PSG, and complete on-line questionnaires. Nightmare data will be examined for frequency and thematic similarity of nightmares to a participant's reported index trauma. Participants' nightmare and index trauma reports will be audio-recorded for use as scripts during SDI. The participant will then undergo two SDI sessions on a single day, one with a nightmare script and one with an index-trauma script, during which they will wear the NINscan. Sessions will be separated by 1 hour and counterbalanced across participants for script order.
Detailed description
Trauma-related nightmares (TRNs) are a hallmark re-experiencing symptom of Posttraumatic Stress Disorder (PTSD) and a severe, re-traumatizing source of distress to those with this condition. Proposed research will investigate whether such nightmares might serve as targets for imaginal exposure during prolonged exposure therapy (PE), a first-line treatment for PTSD. Learning and memory of fear extinction are the neurocognitive underpinnings of PE and increased physiological arousal during PE can aid in extinction learning. Thus, PE using TRNs might enhance treatment outcomes because of the greater immediacy and salience of nightmares relative to the more temporally distant traumatic event. Our research group has developed standardized script-driven imagery (SDI) procedures whereby the degree of psychophysiological arousal induced by recollection of the traumatic event that precipitated posttraumatic symptoms (index trauma) can be assessed. Our team has also developed a novel ambulatory device, the NINscan, that can record skin conductance (SC), facial electromyography (EMG) and electrocardiography (ECG) along with simultaneous functional near-infrared spectroscopic (fNIRS) imaging of the lateral prefrontal cortex (LPFC). The LPFC encompasses regions that activate and/or deactivate during SDI in persons with PTSD and includes the right inferior frontal gyrus (rIFG), an area that plays an important role in inhibiting unwanted behavior and cognition and shows reduced inhibitory performance in PTSD. Following screenings that include a structured clinical evaluation establishing PTSD diagnosis and self-report of a least 2 TRNs per week, qualified participants will record an account of their index trauma. They will then complete 2 weeks of sleep diaries and wrist actigraphy with 4 nights of ambulatory polysomnography (PSG), during which they will audio-record, on a time-stamped digital recorder, a detailed nightmare report following any nightmare-induced awakening. A TRN report having sufficient length, clarity and resemblance to the index trauma will be selected and, along with the index-trauma report, will be re-recorded as a script for SDI. Only participants who generated a TRN suitable for SDI (N=40) will then undergo 2 SDI sessions on a single day while wearing the NINscan. One script will be derived from their index trauma and the other from their TRN, the order of which will be counterbalanced across participants. Psychophysiological response and fNIRS LPFC activation will be compared between scripts using 2 primary outcome measures: (1) a validated canonical psychophysiological variable combining SC, EMG and ECG, and (2) script-related activation of the rIFC. We hypothesize that both activations will be greater for the TRN than for the index-trauma script. Exploratory aims will include (1) examination of the sleep stage and electroencephalographic characteristics of sleep preceding awakenings when a nightmare occurred on a night with PSG.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group study of trauma nightmares, sleep and psychophysiological and neural (fNIRS) responses to imagery of actual trauma and of trauma-related nightmares. Within-subject comparison of psychophysiological and neural responses to imagery of trauma compared to trauma-related nightmare and imagery of unrelated neutral content. Correlational study of psychophysiological and neural responses with clinical self-report measures.
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Other: imaginal probeentirely within-subject outcome variables |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-60 years
- Normal or corrected to normal visual acuity, normal hearing
- Index event that meets DSM-5 PTSD stressor criterion A, viz. "The person was exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence" by direct exposure, witnessing in person, or having a close relative or friend exposed to violent or accidental actual or threatened death.
- Self-report of at least 1 nightmares per week related to the index trauma. The trauma nightmares must contain veridical (vs., symbolic, interpreted, etc.) content that is reminiscent of the index trauma.
- Individuals who meet criteria for at least three of the four DSM-5 criterion categories.
Key exclusion criteria (9 listed)
- Lifetime history of psychosis, bipolar disorder, autism spectrum or other neurodevelopmental disorder, active risk to self or others
- History of sleep apnea or an apnea/hypopnea index of >15 on the diagnostic night of ambulatory PSG (i.e., 15 or more sleep apnea-hypopneas per hour of sleep)
- Neurologic conditions that could confound outcome variables, including past neurosurgical procedures, seizure, neurodegenerative disease, stroke, known structural brain lesion, significant head trauma with extended loss of consciousness and/or persistent neurological sequela (mild TBI allowed)
- Medical conditions that could confound outcome variables such as severe cardiovascular or other systemic disease
- Use of benzodiazepines, beta blockers, prazosin or antipsychotics (antidepressants or mood stabilizers with stable dose for ≥ 3 months allowed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imaginal probetrauma and nightmare imaginal probe/challenge for which psychophysiological and CNS responses are recorded | Other | single arm |
Primary outcome
psychophysiological difference score
Time frame: Immediately after the procedure.
"difference scores" between biosignals from the 30-s epoch of nightmare and index-trauma SDI and their baseline epochs (30s of silence preceding the respective script). Individual skin conductance, heart rate and corrugator EMG difference scores as well as composite SDI-PR score.
fNIRS rlIFG difference score
Time frame: Up to 24 weeks.
O2Hb minus HHb concentrations (HbD) difference score at right lateral inferior frontal (rlIFG) Region of Interest (ROI)
1 secondary outcome
fNIRS difference score for remaining 7 frontolateral ROIs
Time frame: Up to 24 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Individual participant dataSharing planned: Yes. De-identified data shared with NIMH Data Archive (NDA), NDA creates subject GUID
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward F Pace-Schott, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing imaginal probe in people with Posttraumatic Stress Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychophysiological difference score (time frame: Immediately after the procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.