Status:
COMPLETED
MGH Trauma-related Nightmares SDI Study
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Posttraumatic Stress Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
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 c...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05195684
Start Date
June 1 2020
End Date
September 30 2022
Last Update
December 6 2022
Active Locations (1)
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1
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129