Clinical trial NCT03974503: Understanding Trauma Nightmares Using In-Home Measurement
Official title: Characterization of Sleep With Trauma Nightmares Using Ambulatory Sleep Measurement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Nightmares
Stress Disorders, Post-Traumatic
Actigraphy
Respiratory Sinus Arrhythmia
Veterans
Keywords: Nightmares
Cognitive Behavioral Therapy
PTSD
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-06-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two cognitive-behavioral treatments for sleep and nightmares.
Primary purpose: TREATMENT

Brief summary: Trauma-related nightmares in Veterans are associated with poor clinical outcomes, greater substance use, and increased risk of suicide. In spite of an urgent need to reduce the burden of trauma-related nightmares, the underlying physiological changes associated with them are poorly understood, and there are no clear evidence-based recommendations for their treatment. Limitations of current assessment procedures represent a barrier to improved care. In-laboratory sleep studies rarely capture nightmares, limiting the knowledge about them and their response to treatment. This study addresses these limitations by using extended, in-home sleep monitoring to capture sleep data associated with nightmare reports in Veterans, and assessing how these features are altered throughout a cognitive-behavioral nightmare treatment. Results from this study will increase understanding of trauma-related nightmares, and advance strategies for personalizing symptom management for Veterans.

Detailed description: There is a critical need for continued research to better understand trauma-related nightmares with the goal of developing personalized treatment plans. Limitations of current assessment procedures present a significant barrier to improved care. In-laboratory sleep studies rarely capture nightmares and cannot assess change over time, reducing the knowledge of phenotypic markers of nightmares to guide treatment. Therefore, there is a need to assess sleep over multiple nights in the home environment, where nightmares occur. This study aims to significantly enrich knowledge about trauma-related nightmares by using a zero-burden, multi-night, objective sleep measurement method within Veterans' usual sleeping environment prior to and during an evidence-based cognitive-behavioral intervention for nightmares. This study has two primary aims: 1) to identify, with greater precision than previously possible, objective features of sleep associated with trauma-related nightmare occurrences; and 2) to use the treatment for nightmares as interventional probes to determine whether and how changes in sleep physiological parameters identified in Aim 1 covary with changes in subjective nightmare frequency and severity.

The study will include 80 trauma-exposed Veterans reporting with trauma-related nightmares. Eligible participants will monitor their sleep for a week using a multi-night mattress actigraphy implemented in their home. Mattress actigraphy, which measures movements using accelerometers embedded in a mattress topper, employs no body surface sensors. Therefore, this system represents a truly zero-burden method for obtaining intensive longitudinal sleep measurement. During the week of sleep monitoring, participants also will complete one-night of polysomnography (PSG) sleep assessment to calibrate the actigraphic sleep efficiency and to identify untreated sleep apnea. These methods will be used to investigate candidate physiological parameters associated with trauma-related nightmares. After establishing the levels of these candidate markers, this project will assess the impact of a cognitive-behavioral treatment, Exposure, Relaxation, and Rescripting Therapy (ERRT), on the subset of markers which can be measured continuously over the course of the treatment. Participants will be randomized to five weeks of active treatment (ERRT; n = 40) or to five weeks of the comparison treatment (sleep and nightmare management; n = 40). Throughout the course of treatment, participants will continue to sleep while monitored by the mattress actigraphy system. Upon completion of treatment, a post-treatment and follow-up assessment will assess subjective symptom change. Results from this study will provide important information to facilitate increased understanding of the phenomenology, pathophysiology, and treatment of nightmares in trauma-exposed Veterans.

Eligibility criteria: Inclusion Criteria:

* Be a Veteran enrolled to receive VA medical care at the Minneapolis VA Health Care System
* Have stable housing for the duration of the study period
* Have experienced any traumatic event meeting Criterion A for PTSD at least three months before the baseline assessment
* Meet criteria for a current PTSD diagnosis or subthreshold PTSD diagnosis
* Self-report experiencing trauma-related nightmares at least once per week for the past month, that are mostly-remembered and that cause awakening
* Self-report global sleep disturbance indicated by a score of 5 or greater on the Pittsburgh Sleep Quality Index (PSQI)
* Be stable on any psychoactive medications for a minimum of two weeks before the baseline assessment

Exclusion Criteria:

* Inability to provide fully-informed written consent to participate and/or a bed partner does not agree to mattress recording during the in-home portion of the study
* Medical conditions that limit ability to apply the treatment e.g., needing a health aide or caregiver to record sleep diaries, unable to get out of bed without assistance
* Current pregnancy and/or birth of a child within the previous 6 months
* Current alcohol or illicit substance use disorders or early remission (at least 3 months abstinent)
* Active suicidal or homicidal ideation
* A history of any bipolar disorder spectrum disorder or psychotic disorder
* Hospitalization for a mental health disorder in the past 2 months
* Enrolled in current PTSD-focused treatment (e.g., Cognitive Processing Therapy or Prolonged Exposure), current nightmare treatment or a history of treatment failure with a cognitive-behavioral nightmare intervention
* Veterans may also be excluded from participation if they have been identified by the local VA disruptive behavior committee to have displayed disruptive, threatening and/or violent behavior

Primary outcomes:
measure: Change in Actigraphy-derived sleep efficiency (SE)
timeFrame: Nightly up to 7 weeks (Baseline through 1-week post treatment assessment)
measure: Change in Actigraphy-derived respiratory sinus arrhythmia (RSA)
timeFrame: Nightly (Baseline until 1-week post treatment assessment; 7 weeks)
measure: Change in Nightmare Frequency
timeFrame: Baseline past week; Nightly during baseline; 1-week post-treatment; 3-month follow-up treatment period
Secondary outcomes:
measure: Change in PTSD Symptom Severity
timeFrame: Baseline, 1-week post-treatment, 3-month follow-up
measure: Change in Nightmare Severity
timeFrame: Baseline; Nightly during baseline; 1-week post-treatment; 3-month follow-up treatment period
Other outcomes:
measure: Home-based overnight polysomnography
timeFrame: Baseline
measure: Change in Global Sleep Quality
timeFrame: Baseline, 1-week post-treatment, 3-month follow-up
measure: Change in self-report depression symptoms
timeFrame: Baseline, 1-week post-treatment, 3-month follow-up
measure: Change in Nightmare Effects
timeFrame: Baseline, 1-week post-treatment, 3-month follow-up
measure: Change in Fear of Sleep
timeFrame: Baseline, 1-week post-treatment, 3-month follow-up
measure: Change in suicidal ideation
timeFrame: Baseline, 1-week post-treatment, 3-month follow-up
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
Study officials:
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Katherine Elizabeth Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References: