Clinical trial NCT04633668: Impact of Cognitive Behavioral Therapy on Parasomnias
Official title: Pilot RCT of the Impact of Cognitive Behavioral Therapy on Parasomnias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parasomnia
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 (group) X 3 (time)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Parasomnia events
timeFrame: 6 weeks
measure: Nocturnal Activity
timeFrame: 6 weeks
measure: Nightmares
timeFrame: 6 weeks
Secondary outcomes:
measure: Fatigue
timeFrame: 6 weeks
measure: Sleepiness
timeFrame: 6 weeks
measure: Insomnia
timeFrame: 6 weeks
measure: Cognitive
timeFrame: 6 weeks
measure: Impairment
timeFrame: 6 weeks
measure: Depression, Anxiety, and Stress
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Psychealth Center, 771 Bannatyne Avenue
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Shelley Rempel-Rossum
role: STUDY_DIRECTOR
References: