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Completed

NCT Number: NCT04633668

Impact of Cognitive Behavioral Therapy on Parasomnias

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).

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychealth Center, 771 Bannatyne Avenue

Winnipeg, Manitoba, R3E 3N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT for parasomnias (CBT-p)

Behavioral

Psychoeducation, sleep hygiene, imagery re-scripting, scheduled awakenings, safety planning, cognitive therapy, and stress management for 6 weeks

Self-monitoring

Behavioral

Monitoring of sleep quality through sleep diary, actigraphy, nightmare experiences for 6 weeks

Primary outcomes

  1. Parasomnia events

    Time frame: 6 weeks

    # of parasomnia events

  2. Nocturnal Activity

    Time frame: 6 weeks

    activity level during sleep period

  3. Nightmares

    Time frame: 6 weeks

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

Secondary outcomes

  1. Fatigue

    Time frame: 6 weeks

    Multi-Dimensional Fatigue Inventory, 0-16, higher scores mean more fatigue

  2. Sleepiness

    Time frame: 6 weeks

    Epworth Sleepiness Scale, 0-24, higher scores mean more sleepiness

  3. Insomnia

    Time frame: 6 weeks

    Insomnia Severity Index, 0-28, with higher scores meaning more insomnia

  4. Cognitive

    Time frame: 6 weeks

    PROMIS Applied Cognition Scale, 4-20, with higher scores meaning better cognition

  5. Impairment

    Time frame: 6 weeks

    Work and Social Adjustment Scale, 0-40, higher scores mean more impairment

  6. Depression, Anxiety, and Stress

    Time frame: 6 weeks

    Depression, Anxiety, and Stress Scale, o-63, with higher scores meaning more depression, anxiety, and stress

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

Pilot RCT of the Impact of Cognitive Behavioral Therapy on Parasomnias

Acronym: parasomnia

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2020
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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