Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints (e-COSMOS)

University Institute of Geriatrics of Montreal (IUGM)

Status: Enrolling

Conditions: Insomnia

Treatments: Behavioral: education about healthy nutrition habits and communication in older age; Behavioral: cognitive behavioral therapy for sleep, anxiety, and depression

Study type: Interventional

Funder types: Other

Identifiers

NCT06032377

BH210177

Details and patient eligibility

About

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

Full 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.

Enrollment: 275 estimated patients

Sex: All

Ages: 60 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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275 participants in 2 patient groups

online cognitive behavioral therapy for insomnia, anxiety and depression

Experimental group

Description:

10 self-directed modules of cognitive behavioral therapy for insomnia, anxiety and depression, delivered online, once a week

Treatment:

Behavioral: cognitive behavioral therapy for sleep, anxiety, and depression

online intervention on nutrition and communication in older age

Active Comparator group

Description:

10 self-directed modules on healthy nutrition habits and communication strategies, delivered online, once a week

Treatment:

Behavioral: education about healthy nutrition habits and communication in older age