Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal275 enrolled

Overview

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

Participants with insomnia disorder will complete: * A phone interview * Two video conferences (assessment of eligibility and tutorial to set up sleep monitoring devices) * 9 nights of at-home polysomnography with an EEG headband (3 times x 3 nights) * 42 sleep diaries (3 times x 14 days) * 42 days wearing an actigraphy device (3 times x 14 days) * Online questionnaires * Phone call for a check-in with a psychologist * 3 cognitive testing sessions * 10 modules of online information on health, over the course of 10 weeks * In MRI subgroup: 2 in-person testing Good sleeper participants will complete: * A phone interview * Two video conferences (assessment of eligibility and tutorial to set up sleep monitoring devices) * 3 nights of at-home polysomnography with an EEG headband * 14 sleep diaries * 14 days wearing an actigraphy device * Online questionnaires * 1 cognitive testing session * 1 in person session for MRI. In addition, researchers will compare outcomes from participants with insomnia and subjective cognitive complaint to a group of good sleepers to have normative values for imaging data.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Interventions

cognitive behavioral therapy for sleep, anxiety, and depressionBEHAVIORAL

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.

education about healthy nutrition habits and communication in older ageBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 60 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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) Additional exclusion criteria 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 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.

Outcomes

Primary Outcomes

Insomnia severity index

Change in Insomnia Severity Index. ISI range from 0 to 28, higher score means more severe insomnia symptoms.