Impact of Cognitive Behavioral Therapy on Parasomnias (parasomnia)

• ClinicalTrials.gov Identifier: NCT04633668
• Recruitment Status: Completed
• First Posted: November 18, 2020
• Last Update Posted: May 17, 2022
• Sponsor: University of Manitoba
• Information provided by (Responsible Party): Dr. Nora Vincent, University of Manitoba

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Canada, Manitoba

Psychealth Center, 771 Bannatyne Avenue

Winnipeg, Manitoba, Canada, R3E 3N4

Sponsors and Collaborators

University of Manitoba

Investigators

• Study Director: Shelley Rempel-Rossum; University of Manitoba

More Information

• Responsible Party: Dr. Nora Vincent, Psychologist/Professor, University of Manitoba
• ClinicalTrials.gov Identifier: NCT04633668
• Other Study ID Numbers: Umanitoba1
• First Posted: November 18, 2020
• Last Update Posted: May 17, 2022
• Last Verified: May 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations