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

Official title

Improving Sleep to Protect Brain Health in Older Adults: Assessing a Novel Cognitive-behavioral Program for Insomnia Using a Multidomain Web Platform

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

Detailed description

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.

Interventions

• Behavioral 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, logbo
• Behavioral 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

Primary outcome measures

• Insomnia severity index [Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention]
• Subjective cognitive impairment based on cognitive failure questionnaire [Time frame: 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 [Time frame: At baseline and at 24 weeks after the start of the intervention]
• Geriatric anxiety index [Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention]
• Geriatric depression scale [Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention]

Secondary outcome measures (12)

• Sleep quality based on the Pittsburgh sleep quality index [Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention]
• Objective sleep measures based on actigraphy: Sleep Efficiency [Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention]
• Objective sleep measures based on actigraphy: Sleep Latency [Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention]
• Objective sleep measures based on actigraphy: Total Sleep Time [Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention]
• Objective sleep measures based on actigraphy: Wake After Sleep Onset [Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention]
• Objective sleep measures based on EEG: Sleep Efficiency [Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention]
• Objective sleep measures based on EEG: Sleep Latency [Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention]
• Objective sleep measures based on EEG: Total Sleep Time [Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention]
• Objective sleep measures based on EEG: Wake After Sleep Onset [Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention]
• Objective sleep measures based on EEG: Slow Wave Activity [Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention]
• Objective sleep measures based on EEG: Slow Wave Sleep [Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention]
• Subjective sleep measures based on sleep diaries: Sleep Efficiency [Time frame: At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention]

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), 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 2 centers

• The Royal's Institute of Mental Health Research (IMHR) — Ottawa
• Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de l'Île-de-Mon — Montreal

Identifiers

NCT: NCT06032377 · BH210177

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗