Skip to main content
Clinical Trials/NCT04633668
NCT04633668
Completed
Not Applicable

Pilot RCT of the Impact of Cognitive Behavioral Therapy on Parasomnias

University of Manitoba1 site in 1 country20 target enrollmentJanuary 1, 2021
ConditionsParasomnia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parasomnia
Sponsor
University of Manitoba
Enrollment
20
Locations
1
Primary Endpoint
Nocturnal Activity
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This research aims to determine whether cognitive behavioral therapy can effectively reduce parasomnias in a sample of 20 adult outpatients with Non-REM and REM parasomnias. A secondary objective is to assess whether treatment produces improvements in daytime energy, mood, and anxiety symptoms, as well as functional impairment (work/leisure activities).

Detailed Description

Sleep wake disorders are prevalent and impactful conditions often poorly assessed and sub-optimally treated in the clinical setting. Undiagnosed sleep disorders can masquerade as mental health conditions and worsen the outcomes associated with these conditions. Further, sleep disorders can develop from mental health conditions and the reverse is also true (particularly for mood disorders). Successful treatment of sleep disorders requires a targeted approach. Parasomnias are unwanted physical or mental events that occur during sleep or during arousal from sleep. The states of wakefulness, NREM, and REM are normally distinct and occur in an organized and predictable pattern over the 24-hour period. However, in parasomnias, aspects of more than one state co-occur and intermix. There are four types of parasomnias identified by the Diagnostic and Statistical Manual of Mental Disorders ( DSM 5). These include two NREM parasomnias: sleepwalking and sleep terrors, and two REM parasomnias: nightmare disorder and REM sleep behaviour disorder (RSBD). Lifetime prevalence of these conditions ranges from 6.9% (sleepwalking) to 67% (nightmare disorder). In general, NREM parasomnia events are primed by conditions that increase sleep pressure and triggered by sleep-disrupting factors. They are more likely to occur following sleep restriction or deprivation, when SWS rebounds. Immediate triggers of sleepwalking in adults are sleep disruptions associated with sleep-disordered breathing, periodic limb movements, noises and touch. Pilon et al. induced episodes in adult sleepwalkers, but not in non-sleepwalkers, with specific auditory stimuli and this effect was accentuated under conditions of prior sleep deprivation. Currently accepted interventions for parasomnias include pharmacological and psychological treatments. Pharmacological interventions involve the use of sedating medications (benzodiazepines, tricyclic antidepressants) or alpha-1 blocker (Prazosin). Cognitive Behavioral Therapy. Psychological treatments primarily rely on cognitive behavioral therapy to achieve better sleep hygiene, reduced hyperarousal, and to teach the ability to practice with reducing cognitive arousal during the sleep period through planned rehearsal and scheduled awakenings. There are no well elaborated and systematic treatment packages for Non-REM parasomnias and so this protocol will represent an innovation in this area. Therefore, the purpose of the study is to develop and test such a package. Self-Monitoring of Sleep. Self-monitoring of disturbed sleep has been shown to produce small but significant positive impacts on some aspects of sleep (e.g., insomnia). As there is no widely accepted placebo for parasomnia treatment, this is viewed as an adequate control condition. Objectives This research aims to determine whether cognitive behavioral therapy can effectively reduce parasomnias in a sample of 20 adult outpatients with Non-REM and REM parasomnias. A secondary objective is to assess whether treatment produces improvements in daytime energy, mood, and anxiety symptoms, as well as functional impairment (work/leisure activities). The hypotheses of the study are that participants who receive a 6-week program CBT-p therapy will report fewer episodes of parasomnia than those who self-monitor their sleep for 6 weeks, and will have objectively better sleep as measured by the prodigy and actigraphy at one-week (T2) post treatment and at two months post treatment (T3). METHODS Trial Design This will be a single-blind randomized controlled trial with two conditions.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
April 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Nora Vincent

Psychologist/Professor

University of Manitoba

Eligibility Criteria

Inclusion Criteria

  • DSM 5 Parasomnia Disorder
  • at least one parasomnia event per week
  • daytime fatigue or sleepiness
  • 6 months in duration

Exclusion Criteria

  • current use of agents known to triggers parasomnias such as Lithium carbonate, Thioridazine, Chlorpromazine, Perhphenazine, Methaqualone, or Amitriptyline,
  • for participants taking benzodiazepines or Prazosin, a stable dose regime for the past 4 weeks,
  • excessive alcohol consumption defined as the consumption of \> 10 alcoholic beverages per week

Outcomes

Primary Outcomes

Nocturnal Activity

Time Frame: 6 weeks

activity level during sleep period

Nightmares

Time Frame: 6 weeks

Nightmare Experiences Scale, 0-16, higher scores more problematic nightmares

Parasomnia events

Time Frame: 6 weeks

# of parasomnia events

Secondary Outcomes

  • Fatigue(6 weeks)
  • Depression, Anxiety, and Stress(6 weeks)
  • Insomnia(6 weeks)
  • Impairment(6 weeks)
  • Sleepiness(6 weeks)
  • Cognitive(6 weeks)

Study Sites (1)

Loading locations...

Similar Trials