Comparing cognitive behavioral therapy for sleep, with education about healthy nutrition for insomnia
Official title: Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints
Improving Sleep to Protect Brain Health in Older Adults: Assessing a Novel Cognitive-behavioral Program for Insomnia Using a Multidomain Web Platform
- 2 groups
- Sites in Ottawa and Montreal
- Recruiting
Interventions
- Behavioural therapy
cognitive behavioral therapy for sleep, anxiety, and depression
This intervention addresses insomnia, anxiety and depression via modules covering all the core CBTi components: psychoeducation about insomnia, relaxation, cognitive restructuring, stimulus control, sleep restriction and stress management; as well as psychoeducation about anxiety and low mood, behavioral activation strategies, and strategies to better manage ruminations. The modules are adapted to older adults and include short texts, pictures, quizzes with feedback, interactive exercises, logbooks, audio and video recordings.
- Behavioural therapy
education about healthy nutrition habits and communication in older age
This intervention addresses healthy nutrition habits as well as communication and aging. The modules are adapted to older adults and include short texts, pictures, quizzes with feedback, interactive exercises, logbooks, audio and video recordings
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
The Royal's Institute of Mental Health Research (IMHR)
Ottawa, Ontario
- Recruiting
Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de l'Île-de-Montréal. CCSMTL - IUGM
Montreal, Quebec
Eligibility Criteria
See who this study is looking for13 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Exclusion
- −for neuroimaging
- −psychotropic (including hypnotic) medication in the past 2 weeks
- −contraindications for MRI (e.g., pacemaker, metallic implant, claustrophobia)
- −unable or unwilling to come to one of the participating MRI centers (Montreal, Ottawa)
- −medical conditions likely to affect sleep; in particular:
- −current neurological disorder (e.g., epilepsy with any seizure in the past year, concussion in the past 3 months, multiple sclerosis, Parkinson's disease)
- −untreated thyroid disorder
- −chronic pain syndrome self-reported as interfering with sleep (e.g., migraine, fibromyalgia, rheumatoid arthritis)
- −recent and severe infection in the past 3 months (e.g., pneumonia, kidney infection)
- −active cancer or treated cancer with post-cancer treatment for less than 2 years
- −InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → for good sleepers Twenty-five good sleepers without cognitive complaint will be recruited as controlsControl groupThe group a new treatment is measured against.Read more → for the MRI session following the same criteria described above, except that SCI ≥ 17, not meeting the diagnostic criteria for chronic insomnia as assessed by the insomnia module of the SCID and no subjective cognitive complaint.
- −past history of brain lesion (e.g., brain hemorrhage, brain tumor, any condition having required brain surgery)
- −major surgery (i.e., requiring general anesthesia) in the past 3 months
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives cognitive behavioral therapy for sleep, anxiety, and depression.
Registry label: A: online cognitive behavioral therapy for insomnia, anxiety and depression
Group B, the comparison group, receives education about healthy nutrition habits and communication in older age.
Registry label: B: online intervention on nutrition and communication in older age
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 60 years to 99 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 275 people.
The study is currently expected to finish around December 2026.
The main measurement is taken over: At baselineBaselineYour starting measurements, taken before treatment begins.Read more →, at 10-12 weeks and at 24 weeks after the start of the intervention.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Insomnia severity index — measured over At baselineBaselineYour starting measurements, taken before treatment begins.Read more →, at 10-12 weeks and at 24 weeks after the start of the intervention.
Subjective cognitive impairment based on cognitive failure questionnaire — measured over At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention.
Objective cognitive performance based on a composite score for executive functions from the CANTAB — measured over At baseline and at 24 weeks after the start of the intervention.
Geriatric anxiety index — measured over At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention.
The study lists 1 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06032377 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About cognitive behavioral therapy for sleep, anxiety, and depressionBehavioural
This intervention addresses insomnia, anxiety and depression via modules covering all the core CBTi components: psychoeducation about insomnia, relaxation, cognitive restructuring, stimulus control, sleep restriction and stress management; as well as psychoeducation about anxiety and low mood, behavioral activation strategies, and strategies to better manage ruminations. The modules are adapted to older adults and include short texts, pictures, quizzes with feedback, interactive exercises, logbooks, audio and video recordings.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
About education about healthy nutrition habits and communication in older ageBehavioural
This intervention addresses healthy nutrition habits as well as communication and aging. The modules are adapted to older adults and include short texts, pictures, quizzes with feedback, interactive exercises, logbooks, audio and video recordings
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 60 years to 99 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 60 years to 99 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: At baselineBaselineYour starting measurements, taken before treatment begins.Read more →, at 10-12 weeks and at 24 weeks after the start of the intervention.
The study as a whole is currently expected to finish around 2026-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 275 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Ottawa, Ontario, Canada; Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The goal of this randomized controlled clinical trial is to assess a novel cognitive-behavioral program for sleep and mental health using a multidomain web platform (eCBTi+) in participants with insomnia and subjective cognitive complaint. The main questions it aims to answer are: * Whether the eCBTi+ intervention improves sleep (subjective: Insomnia severity index \[ISI\], objective: EEG-based sleep efficiency) sleep and mental health (Geriatric Anxiety Index \[GAI\] and Geriatric Depression Scale \[GDS\]) compared to the control intervention * Whether the eCBTi+ intervention improves cognitive abilities (subjective: Cognitive Failure Questionnaire \[CFQ\], objective: CANTAB executive functions composite score) compared to the control intervention
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.