Actigraphy, Nightmares, Respiratory Sinus Arrhythmia, Stress Disorders, Post-Traumatic, Veterans
Conditions
Keywords
Nightmares, Cognitive Behavioral Therapy, PTSD, Veterans
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.
Interventions
ERRT is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in trauma-exposed adults.
BEHAVIORALSleep and Nightmare Management
This is a manualized protocol developed to be of similar length but exclude the active components of standard ERRT.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors at the post-treatment and follow-up assessment will not be aware of what treatment the participants received.
Intervention model description
Participants will be randomly assigned to one of two cognitive-behavioral treatments for sleep and nightmares.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Actigraphy-derived Sleep Efficiency (SE) Percentage | Week from mattress installation to first treatment session; Week from last treatment session to 1-week post-5-week-treatment assessment | Sleep efficiency will be calculated per night from a mattress actigraphy system and averaged for two time-periods (the week between mattress installation and the first treatment session; the week between the last treatment session to the 1-week post-5-week treatment assessment). Sleep efficiency is defined as the ratio of the aggregate duration of quiescent sleep periods divided by the duration of the total in bed period multiplied by 100 to convert sleep efficiency to percentage points. Lower sleep efficiency indicates more disrupted sleep. |
| Actigraphy-derived Respiratory Sinus Arrhythmia (RSA) | Week from mattress installation to first treatment session; Week from last treatment session to 1-week post-5-week-treatment assessment | Respiratory sinus arrhythmia (RSA) was computed in the 0.15-0.40 Hz band, using median values from high-quality inter-beat-intervals segments, each night. These data were averaged for two time-periods (the week between mattress installation and the first treatment session; the week between the last treatment session to the 1-week post-5-week treatment assessment). Lower RSA indicates more cardiac vagal withdrawal. |
| Change in Nightmare Frequency | Baseline past week; post-5-week-treatment past week; 3-month follow-up past week | This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares) at each assessment (baseline, one week following 5-week treatment, and three months following treatment). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total PTSD Symptom Severity | Baseline, 1-week post-5-week-treatment, 3-month follow-up | Change in PTSD Symptoms will be assessed using the Clinician-Administered PTSD Scale DSM 5 (CAPS-5). The items on the CAPS-5 are on a 5-point scale (0 - 4), (possible range: 0-80, with higher scores indicating more severe symptoms). A symptom is considered present if the severity is rated 2 or higher. Total scores are comprised of four symptom clusters (reexperiencing/intrusions, avoidance, cognitive/emotional and hyperarousal) |
| Change in Nightmare Severity | Baseline past week; post-5-week-treatment past week; 3-month follow-up past week | The variable from the Trauma-Related Nightmare Survey assesses the severity of the nightmares experienced in the past week (range = 0 - 4) at each assessment (baseline, one week following 5-week treatment, and three months following treatment). Higher scores indicate greater nightmare-related severity. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKatherine Elizabeth Miller, PhD
Minneapolis VA Health Care System, Minneapolis, MN
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 49.2 years STANDARD_DEVIATION 12.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 25 |
| other Total, other adverse events | 2 / 23 | 0 / 25 |
| serious Total, serious adverse events | 0 / 23 | 0 / 25 |
Outcome results
None listed