NDR vs. NightWare Wristband for Trauma-Related Nightmares

(NDR/NW Trial)

Overseen By Patricia Spangler, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Uniformed Services University of the Health Sciences

Must not be taking: Beta blockers, Prazosin, Varenicline

Disqualifiers: Psychosis, Bipolar, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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. The investigators will also assess the feasibility of circadian-dependent blood sampling and use of another wristband to collect physiologic data. Specific aims are: (1) Compare evidence of how well participants tolerate and comply with the two treatments and test feasibility of methods and procedures; (2) Collect additional evidence of the potential efficacy of two contrasting non-pharmacologic approaches to treating posttraumatic nightmares; (3) Explore the operational stress index (OSI) as a reliable, objective measure of sleep disturbance and nightmare events.

Will I have to stop taking my current medications?

The trial requires that if you are taking medications for PTSD, depression, anxiety, or insomnia, you must be on a stable dose for 8 weeks before participating. You cannot use synthetic glucocorticoid beta blockers, prazosin, or varenicline.

What data supports the effectiveness of the treatment Nightmare Deconstruction and Reprocessing (NDR) and NightWare Wristband for trauma-related nightmares?

Research shows that cognitive-behavioral therapies, like imagery rescripting and imaginal exposure, effectively reduce nightmare frequency and distress. These therapies are similar to the components used in NDR, suggesting potential effectiveness for trauma-related nightmares. ^{1 2 3 4 5}

How does the NDR vs. NightWare Wristband treatment for trauma-related nightmares differ from other treatments?

The NDR vs. NightWare Wristband treatment is unique because it combines Nightmare Deconstruction and Reprocessing Therapy with a wearable device that detects sleep stages and intervenes during REM sleep to modify nightmares, unlike traditional therapies that rely solely on cognitive-behavioral techniques. ^{2 4 6 7 8}

Research Team

James C West, MD

Principal Investigator

Uniformed Services University of the Health Sciences

Eligibility Criteria

This trial is for active duty service members and veterans who've had at least one nightmare per week in the past month due to PTSD. They must have a certain level of sleep disturbance, measured by an ISI score of 8 or more, and if they're taking meds for PTSD, depression, anxiety, or insomnia, doses must be stable for 8 weeks.

Inclusion Criteria

Active duty service members and veterans

Minimum ISI score of 8

I have experienced at least one nightmare every week for the last month.

Exclusion Criteria

Serious risk of suicide

Psychosis, bipolar disorder, or alcohol or substance use disorder

Inability to recall nightmare content

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either Nightmare Deconstruction and Reprocessing (NDR) or NightWare (NW) treatment. NDR involves exposure-based psychotherapy, while NW uses a wristband device to detect and respond to nightmares.

12 weeks

4 visits (in-person), 12 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of insomnia and nightmare severity.

6 weeks

3 visits (in-person or virtual)

Treatment Details

Interventions

• Nightmare Deconstruction and Reprocessing
• NightWare

Trial Overview The study compares two treatments: Nightmare Deconstruction and Reprocessing (NDR), which is a type of talk therapy facing the nightmares; and NightWare (NW), using a wristband that doesn't involve talking about the nightmares. It also tests new ways to measure treatment effects like blood sampling tied to body clocks.

Participant Groups

Group I: Nightmare Deconstruction and Reprocessing Experimental Treatment 1 Intervention

Psychotherapy that uses exposure to nightmare images for trauma activation with the goal of memory reconsolidation.

Group II: NightWare Experimental Treatment 1 Intervention

Wristband device that detects physiologic signals during sleep that indicate a possible nightmare and gently vibrates to rouse the sleeper without fully waking them.

Who Is Running the Clinical Trial?

Uniformed Services University of the Health Sciences

Lead Sponsor

Trials

130

Recruited

91,100+

NightWare

Industry Sponsor

Trials

5

Recruited

800+

Findings from Research

The dream reorganization approach, which combines systematic desensitization and guided rehearsal, effectively reduced recurrent nightmares in a 10-year-old boy, leading to a complete elimination of nightmares and nighttime disturbances.

This treatment method is based on established theories of dream construction and offers a promising new direction for addressing nightmares, highlighting the potential for cognitive-behavioral strategies in improving sleep-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of recurrent nightmares by the dream reorganization approach. Palace, EM., Johnston, C.[2019]

In a randomized controlled trial with 104 patients suffering from nightmare disorder, both imagery rescripting (IR) and imaginal exposure (IE) significantly reduced nightmare frequency and distress compared to a wait-list control group.

The positive effects of both treatments were not only immediate but also sustained over 3- and 6-month follow-ups, suggesting that IR and IE are effective components of cognitive-behavioral therapies for nightmares.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of imagery rescripting and imaginal exposure for nightmares: A randomized wait-list controlled trial. Kunze, AE., Arntz, A., Morina, N., et al.[2019]

Nightmares affect 4%-10% of the population weekly and are linked to factors like gender, age, stress, and mental health issues, but their exact causes remain unclear.

The authors propose a new framework suggesting that variations in nightmares are influenced by daily emotional pressures and individual emotional reactivity, integrating insights from cognitive neuroscience and emotional memory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disturbed dreaming, posttraumatic stress disorder, and affect distress: a review and neurocognitive model. Levin, R., Nielsen, TA.[2022]

In a case series of four young male U.S. Army Soldiers, disruptive nocturnal behaviors (DNB) and trauma-related nightmares were linked to REM sleep without atonia, indicating a specific sleep disturbance pattern following trauma.

Treatment with prazosin was effective in improving both DNB and nightmares in all patients, suggesting it may be a beneficial intervention for those experiencing trauma-associated sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trauma associated sleep disorder: a proposed parasomnia encompassing disruptive nocturnal behaviors, nightmares, and REM without atonia in trauma survivors. Mysliwiec, V., O'Reilly, B., Polchinski, J., et al.[2022]

Chronic nightmares affect a significant number of trauma survivors and about 5% to 8% of the general population, indicating that they may be a primary sleep disorder rather than just a symptom of other psychiatric issues.

Imagery Rehearsal Therapy (IRT) is the most supported treatment for nightmares, involving four 2-hour sessions that focus on cognitive-imagery techniques, with suggestions for dismantling protocols to tailor the therapy to individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical management of chronic nightmares: imagery rehearsal therapy. Krakow, B., Zadra, A.[2019]

In a study involving 104 participants, imagery rescripting (IR) was found to improve nightmare symptoms by enhancing the individual's mastery over the nightmare content, indicating a mechanism of increased self-efficacy.

Imaginal exposure (IE) also effectively reduced nightmares, but its therapeutic effects were linked to helping individuals better tolerate the negative emotions associated with their nightmares, suggesting that IR and IE operate through different psychological processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mediators of Change in Imagery Rescripting and Imaginal Exposure for Nightmares: Evidence From a Randomized Wait-List Controlled Trial. Kunze, AE., Lancee, J., Morina, N., et al.[2019]

In a study involving 36 patients with nightmare disorder, targeted memory reactivation (TMR) during REM sleep significantly reduced the frequency of nightmares and improved dream emotions compared to a control group after 2 weeks of imagery rehearsal therapy (IRT).

The TMR technique not only enhanced the effectiveness of IRT but also led to a sustained decrease in nightmares over a 3-month period, suggesting its potential for broader applications in treating other psychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing imagery rehearsal therapy for nightmares with targeted memory reactivation. Schwartz, S., Clerget, A., Perogamvros, L.[2023]

A study involving 92 participants over 22 days found that the Nightmare Distress Questionnaire (NDQ) effectively measures 'general nightmare distress' and 'impact on sleep', but its subscale for 'impact on daily reality perception' lacks clear validity.

The NDQ does not distinguish between nightmares and bad dreams, suggesting it may measure negative dreams in general rather than specifically assessing nightmare distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validating Psychometric Questionnaires Using Experience-Sampling Data: The Case of Nightmare Distress. Stieger, S., Kuhlmann, T.[2020]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of recurrent nightmares by the dream reorganization approach. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of imagery rescripting and imaginal exposure for nightmares: A randomized wait-list controlled trial. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Disturbed dreaming, posttraumatic stress disorder, and affect distress: a review and neurocognitive model. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Trauma associated sleep disorder: a proposed parasomnia encompassing disruptive nocturnal behaviors, nightmares, and REM without atonia in trauma survivors. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Clinical management of chronic nightmares: imagery rehearsal therapy. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Mediators of Change in Imagery Rescripting and Imaginal Exposure for Nightmares: Evidence From a Randomized Wait-List Controlled Trial. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Enhancing imagery rehearsal therapy for nightmares with targeted memory reactivation. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Validating Psychometric Questionnaires Using Experience-Sampling Data: The Case of Nightmare Distress. [2020]