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New treatment option for Nightmare
Official title Nightmare Deconstruction and Reprocessing vs. NightWare Wristband
ClinicalTrials.gov ID: NCT06399874
What this study is testing
- What it's testing
- The overall goal of this Phase IIa randomized controlled pilot trial is to assess the potential efficacy of two emerging treatments for post-trauma nightmares and to test the feasibility of study design and methods. Symptom change will be assessed in two treatment arms: (1) Nightmare Deconstruction and Reprocessing (NDR), an exposure-based psychotherapy; and (2) NightWare (NW), a non-exposure approach using a wristband device.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 64
You may be able to join if
- Active duty service members and veterans
- Minimum symptom severity:
- Has had at least 1 nightmare per week for the past month
- Has a minimum ISI score of 8
- If taking medications for PTSD, depression, anxiety, or insomnia, must be on stable dose for 8 weeks.
You likely can't join if
- Serious risk of suicide
- Psychosis, bipolar disorder, or alcohol or substance use disorder
- Untreated moderate to severe sleep apnea
- Use of synthetic glucocorticoid beta blockers, prazosin, or varenicline
- Current evidence-based or experimental psychotherapy directly targeting nightmares, insomnia, or PTSD
- Inability to recall nightmare content
See the full eligibility criteria
- Active duty service members and veterans
- Minimum symptom severity:
- Has had at least 1 nightmare per week for the past month
- Has a minimum ISI score of 8
- If taking medications for PTSD, depression, anxiety, or insomnia, must be on stable dose for 8 weeks.
- Serious risk of suicide
- Psychosis, bipolar disorder, or alcohol or substance use disorder
- Untreated moderate to severe sleep apnea
- Use of synthetic glucocorticoid beta blockers, prazosin, or varenicline
- Current evidence-based or experimental psychotherapy directly targeting nightmares, insomnia, or PTSD
- Inability to recall nightmare content
- Inability to wear wristband or sync wristband data
- Inability to comply with blood draws
- Refusal to consent to DNA analysis of blood samples
- Refusal to consent to audio recording of study visits
- REM sleep behavior disorder or narcolepsy as determined by investigator
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.