MGH Trauma-related Nightmares SDI Study

NCT05195684 | Completed

• 1 other identifier: 2020P001361
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Posttraumatic Stress Disorder

Keywords

nightmares; script driven imagery; functional near-infrared spectroscopy; psychophysiology; polysomnography; sleep

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  Up to 24 weeks.

Secondary Outcomes (1)

• fNIRS difference score for remaining 7 frontolateral ROIs

  Up to 24 weeks.

Study Arms (1)

single arm

OTHER

entirely within-subject outcome variables

Other: imaginal probe

Interventions

imaginal probe OTHER

trauma and nightmare imaginal probe/challenge for which psychophysiological and CNS responses are recorded

single arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Edward F Pace-Schott, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 19, 2022
• Study Start: June 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: biannually
• Access Criteria: NIMH Data Archive staff and NDA-approved investigators

Locations

US (1)