Impact of Cognitive Behavioral Therapy on Parasomnias (parasomnia)
Primary Purpose
Parasomnia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CBT for parasomnias (CBT-p)
Self-Monitoring
Sponsored by
About this trial
This is an interventional treatment trial for Parasomnia
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
Sites / Locations
- Psychealth Center, 771 Bannatyne Avenue
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CBT-p
Self-monitoring
Arm Description
cognitive behavioral therapy, Monitoring of sleep through sleep diaries, nightmare experiences, and actigraphy
Monitoring of sleep through sleep diaries, nightmare experiences, and actigraphy
Outcomes
Primary Outcome Measures
Parasomnia events
# of parasomnia events
Nocturnal Activity
activity level during sleep period
Nightmares
Nightmare Experiences Scale, 0-16, higher scores more problematic nightmares
Secondary Outcome Measures
Fatigue
Multi-Dimensional Fatigue Inventory, 0-16, higher scores mean more fatigue
Sleepiness
Epworth Sleepiness Scale, 0-24, higher scores mean more sleepiness
Insomnia
Insomnia Severity Index, 0-28, with higher scores meaning more insomnia
Cognitive
PROMIS Applied Cognition Scale, 4-20, with higher scores meaning better cognition
Impairment
Work and Social Adjustment Scale, 0-40, higher scores mean more impairment
Depression, Anxiety, and Stress
Depression, Anxiety, and Stress Scale, o-63, with higher scores meaning more depression, anxiety, and stress
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04633668
Brief Title
Impact of Cognitive Behavioral Therapy on Parasomnias
Acronym
parasomnia
Official Title
Pilot RCT of the Impact of Cognitive Behavioral Therapy on Parasomnias
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parasomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 (group) X 3 (time)
Masking
Participant
Masking Description
Self-Monitoring of sleep
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT-p
Arm Type
Experimental
Arm Description
cognitive behavioral therapy, Monitoring of sleep through sleep diaries, nightmare experiences, and actigraphy
Arm Title
Self-monitoring
Arm Type
Active Comparator
Arm Description
Monitoring of sleep through sleep diaries, nightmare experiences, and actigraphy
Intervention Type
Behavioral
Intervention Name(s)
CBT for parasomnias (CBT-p)
Intervention Description
Psychoeducation, sleep hygiene, imagery re-scripting, scheduled awakenings, safety planning, cognitive therapy, and stress management for 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
Self-Monitoring
Intervention Description
Monitoring of sleep quality through sleep diary, actigraphy, nightmare experiences for 6 weeks
Primary Outcome Measure Information:
Title
Parasomnia events
Description
# of parasomnia events
Time Frame
6 weeks
Title
Nocturnal Activity
Description
activity level during sleep period
Time Frame
6 weeks
Title
Nightmares
Description
Nightmare Experiences Scale, 0-16, higher scores more problematic nightmares
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Fatigue
Description
Multi-Dimensional Fatigue Inventory, 0-16, higher scores mean more fatigue
Time Frame
6 weeks
Title
Sleepiness
Description
Epworth Sleepiness Scale, 0-24, higher scores mean more sleepiness
Time Frame
6 weeks
Title
Insomnia
Description
Insomnia Severity Index, 0-28, with higher scores meaning more insomnia
Time Frame
6 weeks
Title
Cognitive
Description
PROMIS Applied Cognition Scale, 4-20, with higher scores meaning better cognition
Time Frame
6 weeks
Title
Impairment
Description
Work and Social Adjustment Scale, 0-40, higher scores mean more impairment
Time Frame
6 weeks
Title
Depression, Anxiety, and Stress
Description
Depression, Anxiety, and Stress Scale, o-63, with higher scores meaning more depression, anxiety, and stress
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shelley Rempel-Rossum
Organizational Affiliation
University of Manitoba
Official's Role
Study Director
Facility Information:
Facility Name
Psychealth Center, 771 Bannatyne Avenue
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3N4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Cognitive Behavioral Therapy on Parasomnias
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