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NCT05195684 · ClinicalTrials.gov registry record · NA
MGH Trauma-related Nightmares SDI Study
A NA study of Post Traumatic Stress Disorder, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05195684: Completed NA study of Post Traumatic Stress Disorder, sponsored by Massachusetts General Hospital.
NCT05195684 is a NA study of Post Traumatic Stress Disorder that has completed, run by Massachusetts General Hospital. The registered enrollment target is 30 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05195684, a NA study of Post Traumatic Stress Disorder, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
"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.
Conditions Studied
Interventions
- OTHER imaginal probe
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Charlestown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2022-09-30 |
| Phase | NA |
What the finished NCT05195684 record still lists
NCT05195684 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 1 intervention - of which imaginal probe is the first listed.
NCT05195684 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05195684 about?
NCT05195684 is a clinical study titled "MGH Trauma-related Nightmares SDI Study". 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. Par...
What is the current status of trial NCT05195684?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2020-06-01. Estimated completion is 2022-09-30.
What conditions does trial NCT05195684 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT05195684?
The interventions under investigation include: imaginal probe (OTHER).
Who is sponsoring clinical trial NCT05195684?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05195684 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05195684's enrollment target sits among peer trials
30 210th of 262 higher than 44 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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