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New treatment option for Insomnia
Official title Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints
ClinicalTrials.gov ID: NCT06032377
What this study is testing
- What it's testing
- 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
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 99. Healthy volunteers may be eligible.
You may be able to join if
- Inclusion
- age 60 years or older at the time of enrolment
- Sleep Condition Indicator, SCI ≤ 16 and/or meeting DSM-V criteria based on the symptoms assessed by the SCI
- subjective cognitive complaints (self-report version of Everyday Cognition scale (ECog), score ≥ 2 on any item)
- ability to read and understand French or English
You likely can't join if
- 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...
See the full eligibility criteria
- Inclusion
- age 60 years or older at the time of enrolment
- Sleep Condition Indicator, SCI ≤ 16 and/or meeting DSM-V criteria based on the symptoms assessed by the SCI
- subjective cognitive complaints (self-report version of Everyday Cognition scale (ECog), score ≥ 2 on any item)
- ability to read and understand French or English
- ability to use a smartphone or tablet, and access to home internet connection
- If on hypnotic or psychotropic medication (including cannabis), being on stable dosage for at least 2 months prior to study entry
- Score on the STOP-BANG questionnaire \< 3 corresponding to participants with low risk of obstructive sleep apnea Exclusion
- located outside of Québec or Ontario
- current hospitalization or planned major surgery
- uncorrected severe hearing or vision impairment
- reported diagnosis of major neurocognitive disorder or mild cognitive impairment (MCI)
- performance suggestive of major neurocognitive disorder or MCI on T-MoCA \< 17
- reported diagnosis of schizophrenia or bipolar disorder
- reported diagnosis or positive screen on the MINI for psychotic or bipolar disorders
- high suicidal risk, as assessed by the modified Columbia-Suicide Severity Rating Scale
- reported diagnosis or positive screening (apnea-hypopnea index \>30 on a level 3 home sleep apnea test) for another untreated sleep disorder (e.g., sleep disordered breathing (OSA), REM sleep behavior disorder (RBD)...
- current shift work
- currently receiving CBT, having received CBTi in the past
- frequent alcohol consumption having an impact on functionning (\>10 glasses/week and having a significant impact on functionning)
- illicit drugs use (more than once a month) Additional
- 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)
- 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
- 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 Inclusion/exclusion criteria for good sleepers Twenty-five good sleepers without cognitive complaint will be recruited as controls for the...
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 99 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.