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Impact of Cognitive Behavioral Therapy on Parasomnias (parasomnia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04633668
Recruitment Status : Completed
First Posted : November 18, 2020
Last Update Posted : May 17, 2022
Sponsor:
Information provided by (Responsible Party):
Dr. Nora Vincent, University of Manitoba

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).

Condition or disease Intervention/treatment Phase
Parasomnia Behavioral: CBT for parasomnias (CBT-p) Behavioral: Self-Monitoring Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 (group) X 3 (time)
Masking: Single (Participant)
Masking Description: Self-Monitoring of sleep
Primary Purpose: Treatment
Official Title: Pilot RCT of the Impact of Cognitive Behavioral Therapy on Parasomnias
Actual Study Start Date : January 1, 2021
Actual Primary Completion Date : April 30, 2022
Actual Study Completion Date : April 30, 2022

Arm Intervention/treatment
Experimental: CBT-p
cognitive behavioral therapy, Monitoring of sleep through sleep diaries, nightmare experiences, and actigraphy
Behavioral: CBT for parasomnias (CBT-p)
Psychoeducation, sleep hygiene, imagery re-scripting, scheduled awakenings, safety planning, cognitive therapy, and stress management for 6 weeks

Active Comparator: Self-monitoring
Monitoring of sleep through sleep diaries, nightmare experiences, and actigraphy
Behavioral: Self-Monitoring
Monitoring of sleep quality through sleep diary, actigraphy, nightmare experiences for 6 weeks




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04633668


Locations
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Canada, Manitoba
Psychealth Center, 771 Bannatyne Avenue
Winnipeg, Manitoba, Canada, R3E 3N4
Sponsors and Collaborators
University of Manitoba
Investigators
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Study Director: Shelley Rempel-Rossum University of Manitoba
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Responsible Party: Dr. Nora Vincent, Psychologist/Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT04633668    
Other Study ID Numbers: Umanitoba1
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Neurologic Manifestations