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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| CBT-p | Experimental | cognitive behavioral therapy, Monitoring of sleep through sleep diaries, nightmare experiences, and actigraphy Receives: Behavioral: CBT for parasomnias (CBT-p) |
| Self-monitoring | Active comparator | Monitoring 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.
Parasomnia events
# of parasomnia events
Measured: 6 weeks
Nocturnal Activity
activity level during sleep period
Measured: 6 weeks
Nightmares
Nightmare Experiences Scale, 0-16, higher scores more problematic nightmares
Measured: 6 weeks
Secondary outcomes (6)
Fatigue
Multi-Dimensional Fatigue Inventory, 0-16, higher scores mean more fatigue
Measured: 6 weeks
Sleepiness
Epworth Sleepiness Scale, 0-24, higher scores mean more sleepiness
Measured: 6 weeks
Insomnia
Insomnia Severity Index, 0-28, with higher scores meaning more insomnia
Measured: 6 weeks
Cognitive
PROMIS Applied Cognition Scale, 4-20, with higher scores meaning better cognition
Measured: 6 weeks
Impairment
Work and Social Adjustment Scale, 0-40, higher scores mean more impairment
Measured: 6 weeks
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.
- First posted18 Nov 2020
- Study start1 Jan 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParasomniaStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Nora Vincent, University of Manitoba
- Investigators
- Shelley Rempel-Rossum, Study director, University of Manitoba
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
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot RCT of the Impact of Cognitive Behavioral Therapy on Parasomnias
- ClinicalTrials.gov ID
- NCT04633668
- Acronym / sponsor ID
- parasomnia / Umanitoba1
- Conditions
- Parasomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 (group) X 3 (time)
| Arm | Type | Receives |
|---|---|---|
| CBT-p | Experimental | Behavioral: CBT for parasomnias (CBT-p)cognitive behavioral therapy, Monitoring of sleep through sleep diaries, nightmare experiences, and actigraphy |
| Self-monitoring | Active comparator | Behavioral: Self-MonitoringMonitoring of sleep through sleep diaries, nightmare experiences, and actigraphy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- DSM 5 Parasomnia Disorder
- at least one parasomnia event per week
- daytime fatigue or sleepiness
- 6 months in duration
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT for parasomnias (CBT-p)Psychoeducation, sleep hygiene, imagery re-scripting, scheduled awakenings, safety planning, cognitive therapy, and stress management for 6 weeks | Behavioural | CBT-p |
| Self-MonitoringMonitoring of sleep quality through sleep diary, actigraphy, nightmare experiences for 6 weeks | Behavioural | Self-monitoring |
Primary outcome
Parasomnia events
Time frame: 6 weeks
# of parasomnia events
Nocturnal Activity
Time frame: 6 weeks
activity level during sleep period
Nightmares
Time frame: 6 weeks
Nightmare Experiences Scale, 0-16, higher scores more problematic nightmares
6 secondary outcomes
Fatigue
Time frame: 6 weeks
Sleepiness
Time frame: 6 weeks
Insomnia
Time frame: 6 weeks
Cognitive
Time frame: 6 weeks
Impairment
Time frame: 6 weeks
Depression, Anxiety, and Stress
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 36468650Vincent 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelley Rempel-Rossum study director
University of Manitoba
1 site in 1 country: see every site and its status.
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.