NDR vs. NightWare Wristband for Trauma-Related Nightmares
(NDR/NW Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
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
Prior Safety Data
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. We will also assess the feasibility of circadian-dependent blood sampling and use of another wristband to collect physiologic data. Toward this goal, we will pursue the following specific aims: (1) Compare evidence of how well participants tolerate and comply with the different treatments and to 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.
12345How 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.
24678Eligibility 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.
+1 more
Exclusion Criteria
Serious risk of suicide
Psychosis, bipolar disorder, or alcohol or substance use disorder
Inability to recall nightmare content
+8 more
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Nightmare Deconstruction and ReprocessingExperimental Treatment1 Intervention
Psychotherapy that uses exposure to nightmare images for trauma activation with the goal of memory reconsolidation.
Group II: NightWareExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Uniformed Services University of the Health SciencesBethesda, MD
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Who Is Running the Clinical Trial?
Uniformed Services University of the Health SciencesLead Sponsor
NightWareIndustry Sponsor
References
Treatment of recurrent nightmares by the dream reorganization approach. [2019]Dream reorganization is introduced as a new theoretical and treatment approach to the alleviation of recurrent nightmares, derived from the principles of the Seligman and Yellen (1987) theory of dream construction. The cognitive-behavioral dream reorganization treatment package consists of two treatment components. Systematic desensitization with coping self-statements is employed to alter the emotional episode by counterconditioning a relaxation response to anxiety-evoking nightmare content. Guided rehearsal of mastery endings to dream content hierarchy items is added to modify the secondary visual stimuli associated with recurrent nightmares. The dream reorganization approach is presented in the case of a 10-year-old male with a fear of sleeping alone due to recurrent nightmares. Following treatment, the client reported 100% reduction in nightmares and demonstrated 100% reduction in night time arrival in the parents' room. The present report provides a theoretical rationale for dream reorganization, and future directions for research in the treatment of recurrent nightmares.
Efficacy of imagery rescripting and imaginal exposure for nightmares: A randomized wait-list controlled trial. [2019]Nightmares can be effectively treated with cognitive-behavioral therapies. Though it remains elusive which therapeutic elements are responsible for the beneficial effects on nightmare symptoms, imagery rescripting (IR) and imaginal exposure (IE) are commonly identified as active treatment components of nightmare therapies. With this randomized controlled trial, we compared IR and IE as individual treatments to a wait-list (WL) condition to determine whether these particular therapeutic elements ameliorate nightmare symptoms. For this purpose, 104 patients with a primary DSM-5 diagnosis of nightmare disorder were randomly assigned to three weekly individual sessions of either IR or IE, or WL. Results showed that compared to WL, both interventions effectively reduced nightmare frequency (ΔdIR-WL = 0.74; ΔdIE-WL = 0.70) and distress (ΔdIR-WL = 0.98; ΔdIE-WL = 1.35) in a sample that predominantly consisted of idiopathic nightmare sufferers. The effects of IR and IE were comparable to those observed for other psychological nightmare treatments. Initial effects at post-treatment were sustained at 3- and 6-months follow-up, indicating that IR and IE both seem to be efficacious treatment components of nightmare therapies. Additional research is needed to directly compare IR and IE among both idiographic and posttraumatic nightmare sufferers with respect to treatment expectancy, acceptability, and effectiveness.
Disturbed dreaming, posttraumatic stress disorder, and affect distress: a review and neurocognitive model. [2022]Nightmares are common, occurring weekly in 4%-10% of the population, and are associated with female gender, younger age, increased stress, psychopathology, and dispositional traits. Nightmare pathogenesis remains unexplained, as do differences between nontraumatic and posttraumatic nightmares (for those with or without posttraumatic stress disorder) and relations with waking functioning. No models adequately explain nightmares nor have they been reconciled with recent developments in cognitive neuroscience, fear acquisition, and emotional memory. The authors review the recent literature and propose a conceptual framework for understanding a spectrum of dysphoric dreaming. Central to this is the notion that variations in nightmare prevalence, frequency, severity, and psychopathological comorbidity reflect the influence of both affect load, a consequence of daily variations in emotional pressure, and affect distress, a disposition to experience events with distressing, highly reactive emotions. In a cross-state, multilevel model of dream function and nightmare production, the authors integrate findings on emotional memory structures and the brain correlates of emotion.
Trauma associated sleep disorder: a proposed parasomnia encompassing disruptive nocturnal behaviors, nightmares, and REM without atonia in trauma survivors. [2022]To characterize the clinical, polysomnographic and treatment responses of patients with disruptive nocturnal behaviors (DNB) and nightmares following traumatic experiences.
Clinical management of chronic nightmares: imagery rehearsal therapy. [2019]Problems with nightmares are reported by a sizable proportion of individuals with a history of trauma and by approximately 5% to 8% of the general population. Chronic nightmares may represent a primary sleep disorder rather than a symptom of a psychiatric disorder, and direct targeting of nightmares is a feasible clinical approach to the problem. Of the treatments proposed, imagery rehearsal therapy (IRT) has received the most empirical support. An up-to-date account of this cognitive-imagery approach shows how to treat nightmares during 4 roughly 2-hr sessions. The main points covered in each therapy session and their underlying rationale are presented. Dismantling protocols are suggested to discern active ingredients of IRT and to develop flexible applications based on patients' needs.
Mediators of Change in Imagery Rescripting and Imaginal Exposure for Nightmares: Evidence From a Randomized Wait-List Controlled Trial. [2019]Imagery rescripting (IR) and imaginal exposure (IE) are two efficacious treatments for nightmare disorder, but their discrete underlying mechanism(s) remain largely unknown. We therefore examined mediators of the treatment effects of IR and IE in a randomized wait-list controlled trial (N = 104). Therapeutic outcomes were assessed at pre- and post-assessment, and mediator assessment took place in between treatment sessions to establish a temporal relationship between mediators and nightmare symptoms (i.e., frequency and distress). In line with the hypothesis, enhanced mastery (or self-efficacy) of the nightmare content mediated the therapeutic efficacy of IR. Furthermore, the treatment effects of IE were mediated by increased tolerability of the negative emotions elicited by nightmares. Even though IR and IE for nightmares seem to produce similar therapeutic effects, the results of this study suggest that IR and IE tap into different underlying processes.
Enhancing imagery rehearsal therapy for nightmares with targeted memory reactivation. [2023]Nightmare disorder (ND) is characterized by dreams with strong negative emotions occurring during rapid eye movement (REM) sleep. ND is mainly treated by imagery rehearsal therapy (IRT), where the patients are asked to change the negative story line of their nightmare to a more positive one. We here used targeted memory reactivation (TMR) during REM sleep to strengthen IRT-related memories and accelerate remission of ND. Thirty-six patients with ND were asked to perform an initial IRT session and, while they generated a positive outcome of their nightmare, half of the patients were exposed to a sound (TMR group), while no such pairing took place for the other half (control group). During the next 2 weeks, all patients performed IRT every evening at home and were exposed to the sound during REM sleep with a wireless headband, which automatically detected sleep stages. The frequency of nightmares per week at 2 weeks was used as the primary outcome measure. We found that the TMR group had less frequent nightmares and more positive dream emotions than the control group after 2 weeks of IRT and a sustained decrease of nightmares after 3 months. By demonstrating the effectiveness of TMR during sleep to potentiate therapy, these results have clinical implications for the management of ND, with relevance to other psychiatric disorders too. Additionally, these findings show that TMR applied during REM sleep can modulate emotions in dreams.
Validating Psychometric Questionnaires Using Experience-Sampling Data: The Case of Nightmare Distress. [2020]Nightmares are a comparatively frequent phenomenon. They are often accompanied by emotional distress and gain clinical relevance when recurrent. To assess how much distress nightmares cause the individual, the Nightmare Distress Questionnaire (NDQ, Belicki, 1992) is probably the most often used measure. However, its validity is still disputed. To analyze the validity of the proposed three NDQ subscales in more detail, we conducted an experience sampling study, gathering data either in real-time or short retrospective timeframes over the course of 22 days twice per day (N = 92 participants). The measurements were implemented via a mobile app using participants' own smartphones. Besides the dream quality, we assessed concepts on a daily basis that past research found to be related to dreams. These included critical life events, alcohol consumption, eating behavior, and well-being. We found that only the subscales "general nightmare distress" and "impact on sleep" showed convergent as well as divergent validity. The validity of the subscale "impact on daily reality perception" is unclear. If at all, this subscale is rather indirectly associated with nightmare distress. Furthermore, all of the NDQ items did not differentiate between a bad dream and a nightmare, which suggests that the NDQ might rather be a measure of negative dreams in general and not nightmares in particular. Based on the present experience sampling design, we propose to advance the validation process by further possibilities, such as an item-level, person-level, and multi-level approach. This approach seems to be especially fruitful for concepts which are not very salient (e.g., laughter), can hardly be remembered retrospectively (e.g., dream content), or are potentially threatened by recall biases (e.g., alcohol consumption).