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ParasomniaparasomniaNCT04633668

Impact of Cognitive Behavioral Therapy on Parasomnias

A study testing CBT for parasomnias (CBT-p) and Self-Monitoring in people with Parasomnia, run by University of Manitoba at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Parasomnia
What is being tested?
CBT for parasomnias (CBT-p) and Self-Monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
1 Jan 2021to 30 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • DSM 5 Parasomnia Disorder
  • at least one parasomnia event per week
  • daytime fatigue or sleepiness
  • 6 months in duration

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Psychealth Center, 771 Bannatyne Avenue

    Winnipeg, Manitoba, R3E 3N4

Other trials in Canada

About this study

Official title: Pilot RCT of the 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).

Read the 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.

Conditions
Parasomnia
Being tested
CBT for parasomnias (CBT-p), Self-Monitoring
Medical subject headings
Parasomnias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBT for parasomnias (CBT-p)Behavioural

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

  • Self-MonitoringBehavioural

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

Study groups in NCT04633668
Study groupRoleWhat they receive
CBT-pExperimentalcognitive behavioral therapy, Monitoring of sleep through sleep diaries, nightmare experiences, and actigraphy
Receives: Behavioral: CBT for parasomnias (CBT-p)
Self-monitoringActive comparatorMonitoring of sleep through sleep diaries, nightmare experiences, and actigraphy
Receives: Behavioral: Self-Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parasomnia events

    # of parasomnia events

    Measured: 6 weeks

  2. Nocturnal Activity

    activity level during sleep period

    Measured: 6 weeks

  3. Nightmares

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

    Measured: 6 weeks

Secondary outcomes (6)
  1. Fatigue

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

    Measured: 6 weeks

  2. Sleepiness

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

    Measured: 6 weeks

  3. Insomnia

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

    Measured: 6 weeks

  4. Cognitive

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

    Measured: 6 weeks

  5. Impairment

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

    Measured: 6 weeks

  6. Depression, Anxiety, and Stress

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

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2020
  2. Study start1 Jan 2021
  3. Primary completion30 Apr 2022
  4. Study completion30 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2 (group) X 3 (time)
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04633668
Sponsor's protocol ID
Umanitoba1
Acronym
parasomnia
Status last verified
May 2022
First submitted
6 Nov 2020
Last updated
17 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vincent N, Dirkse D, Giannouli E, McQuarrie A. Transdiagnostic cognitive behavioral therapy for nightmares and parasomnias. J Clin Sleep Med. 2023 Mar 1;19(3):499-509. doi: 10.5664/jcsm.10374.

    PubMed 36468650

Questions about this trial

What is this clinical trial studying?

A study testing CBT for parasomnias (CBT-p) and Self-Monitoring in people with Parasomnia, run by University of Manitoba at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parasomnia events (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04633668, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.

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