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
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
275 participants
Nov 15, 2023
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria22
- 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), restless legs syndrome (RLS); individuals with treated and controlled OSA (residual apnea-hypopnea index \<30 and good therapeutic compliance) or RLS will not be excluded
- 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)
Exclusion Criteria11
- 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
Interventions
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.
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
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06032377