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

Insomnia Clinical Trial

— e-COSMOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06032377
• Other study ID #: BH210177
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
• Contact: Thien Thanh Dang-Vu, MD PhD
• Phone: +1 (514) 340-3540
• Email: tt.dangvu[@]concordia.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 275
• Est. completion date: December 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 99 Years

Eligibility

Inclusion

• age 60 years or older at the time of enrolment
• Sleep Condition Indicator, SCI = 16 and meeting DSM-V criteria based on the symptoms assessed by the SCI
• subjective cognitive complaints (self-report version of Everyday Cognition scale (ECog), score = 3 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 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 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 or RLS will not be excluded)
• apnea-hypopnea index >10 on a level 3 home sleep apnea test or residual AHI >10 for individuals on CPAP
• current shift work
• currently receiving CBT
• frequent alcohol consumption (>10 glasses/week), or illicit drugs (more than once a month)
• smoking more than 10 cigarettes/day 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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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, logbooks, audio and video recordings.
• 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

Locations

Country	Name	City	State
Canada	Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de l'Île-de-Montréal. CCSMTL - IUGM	Montréal	Quebec
Canada	The Royal's Institute of Mental Health Research (IMHR)	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia severity index	Change in Insomnia Severity Index. ISI range from 0 to 28, higher score means more severe insomnia symptoms.	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Primary	Subjective cognitive impairment based on cognitive failure questionnaire	Change in Cognitive Failure Questionnaire (CFQ) total score as well as number of items with a score = 3. The CFQ comprises 25 items and total score corresponds to the sum of all completed items, total score range from 0 to 100.	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Primary	Objective cognitive performance based on a composite score for executive functions from the CANTAB	Change in the Cambridge Neuropsychological Test Automated Battery (CANTAB) executive functions composite score (Intra-Extra Dimensional Set Shift [IED] and Stocking of Cambridge [SOC], ranging from 0 to 100 with higher scores reflecting poorer executive functions.	At baseline and at 24 weeks after the start of the intervention
Primary	Geriatric anxiety index	Change in Geriatric anxiety index. GAI scores range from 0 to 20 and higher scores mean more severe anxiety symptoms.	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Primary	Geriatric depression scale	Change in Geriatric depression scale. GDS scores range from 0 to 15, higher scores mean more severe depression symptoms.	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Sleep quality based on the Pittsburgh sleep quality index	Change in Pittsburgh sleep quality index. PSQI scores range from 0 to 21, higher scores mean worse sleep quality.	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Objective sleep measures based on actigraphy: Sleep Efficiency	Change in Sleep Efficiency (SE) from actigraphs. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Objective sleep measures based on actigraphy: Sleep Latency	Change in Sleep Latency (SL) from actigraphs. Sleep latency in minutes, greater values mean longer time to fall asleep.	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Objective sleep measures based on actigraphy: Total Sleep Time	Change in Total Sleep Time (TST) from actigraphs. Total Sleep Time in minutes, greater values mean longer time spent asleep.	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Objective sleep measures based on actigraphy: Wake After Sleep Onset	Change in Wake After Sleep Onset (WASO) from actigraphs. Wake After Sleep Onset in minutes, greater values mean longer time spent awake.	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Objective sleep measures based on EEG: Sleep Efficiency	Change in Sleep Efficiency (SE) from EEG. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Objective sleep measures based on EEG: Sleep Latency	Change in Sleep Latency (SL) from EEG. Sleep latency in minutes, greater values mean longer time to fall asleep	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Objective sleep measures based on EEG: Total Sleep Time	Change in Total Sleep Time (TST) from EEG. Total Sleep Time in minutes, greater values mean longer time spent asleep.	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Objective sleep measures based on EEG: Wake After Sleep Onset	Change in Wake After Sleep Onset (WASO) from EEG. Wake After Sleep Onset in minutes, greater values mean longer time spent awake.	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Objective sleep measures based on EEG: Slow Wave Activity	Change in Slow Wave Activity (SWA) power density from EEG.	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Objective sleep measures based on EEG: Slow Wave Sleep	Change in Slow Wave Sleep (SWS) from EEG. Slow Wave Sleep in minutes, greater values mean longer time spent in Slow Wave Sleep.	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Subjective sleep measures based on sleep diaries: Sleep Efficiency	Change in Sleep Efficiency (SE) from sleep diaries. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Subjective sleep measures based on sleep diaries: Sleep Latency	Change in Sleep Latency (SL) from sleep diaries. Sleep latency in minutes, greater values mean longer time to fall asleep.	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Subjective sleep measures based on sleep diaries: Total Sleep Time	Change in Total Sleep Time (TST) from sleep diaries. Total Sleep Time in minutes, greater values mean longer time spent asleep.	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Subjective sleep measures based on sleep diaries: Wake After Sleep Onset	Change in Wake After Sleep Onset (WASO) from sleep diaries. Wake After Sleep Onset in minutes, greater values mean longer time spent awake.	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Cognitive performances from the CANTAB: Rapid Visual Information Processing (RVP)	Change in Rapid Visual Information Processing RVP - A' (sensitivity to the target sequence) and probability of false alarm (range: 0.00 - 1.00; bad to good)].	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Cognitive performances from the CANTAB: Spatial Span (SSP)	Change in Spatial Span [SSP - Forward/Reverse Span Lengths (range: 2-9; bad to good]	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Cognitive performances from the CANTAB: Spatial Working Memory (SWM)	Change in Spatial Working Memory [SWM - Number of times the subject incorrectly revisits a box in which a token has previously been found (range: 0 - 8; good to bad)].	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Cognitive performances from the CANTAB: Paired Associates Learning (PAL)	Change in Paired Associates Learning [PAL - Total errors adjusted (range: 0 - 70; good to bad; First attempt memory score (range: 0-20; bad to good)]	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Cognitive performances from the CANTAB: Pattern Recognition Memory (PRM)	Change in Pattern Recognition Memory [PRM - Percent correct immediate/delayed (range: 0-100; bad to good)].	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Cognitive performances from the CANTAB: Intra-Extra Dimensional Set Shift (IED)	Intra-Extra Dimensional Set Shift, IED - number of times that the subject failed to select the stimulus compatible with the current rule on the stage where the extra-dimensional shift occurs (range: 0-50; good to bad); Total errors adjusted (range: 0-402; good to bad)	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Cognitive performances from the CANTAB: Stocking of Cambridge (SOC)	Stocking of Cambridge, SOC - Number of problems successfully completed in the minimum possible number of moves (range: 0 - 12; bad to good); Mean number of moves required to complete problems (range: 5 - 12; good to bad); Initial thinking time median (range: 0 ms to 8; longer times may indicate better planning efforts	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Negative emotional bias measured on the Cambridge Neuropsychological Test Automated Battery (CANTAB)	Change in Emotional Bias Task (EBT) subscales from the CANTAB [EBT - proportion of trials rated as 'Happy' (range: 0-15, bad to good)].	At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Memory encoding fMRI activations	Change in fMRI activation level (arbitrary units) in the hippocampus, temporal lobe and prefrontal cortex during the memory encoding task.	At baseline, at 24 weeks after the start of the intervention
Secondary	Cognitive performance (classical neuropsychological tests)	all subscales from classical neuropsychological test battery (Trail Making Test A [TMT-A], Digit Symbol Substitution test (WAIS), Boston Naming Test, Digit Span - forward and backward (WAIS), Rey Auditory Verbal Learning test, Logical Memory I and II (Wechsler Memory Scale), Brief Visuospatial Memory Test Revised (BVMT-R), Trail Making Test B [TMT-B], Verbal Fluency Test (from D-KEFS), Color-Word Interference Test [Stroop test, from D-KEFS]).	At baseline, at 24 weeks after the start of the intervention
Secondary	Cortical thickness measures	Change in cortical thickness (mm) in the prefrontal cortex and precuneus.	At baseline, at 24 weeks after the start of the intervention
Secondary	Fractional anisotropy	Change in fractional anisotropy of the superior longitudinal fasciculus and internal capsule.	At baseline, at 24 weeks after the start of the intervention
Secondary	Resting-state measures	Change in the ratio between segregation and integration within and between the default-mode network and the limbic network during resting-state as measured with functional connectivity.	At baseline, at 24 weeks after the start of the intervention
Secondary	GABA/glutamate ratio from magnetic resonance spectroscopy	Change in the GABA/glutamate ratio in the anterior cingulate cortex.	At baseline, at 24 weeks after the start of the intervention
Secondary	Treatment-mediated association between changes in sleep and cognition	Mediation estimate of the extent to which exposure to eCBTi+ explains the association between improved sleep and improved cognition	At 10-12 weeks and at 24 weeks after the start of the intervention
Secondary	Satisfaction from System Usability Scale	Score on the System Usability Scale, reflecting the degree to which participants were satisfied with the eCBTi+ and the control intervention. Percentage ranging between 0 and 100%.	At 10-12 weeks after the start of the intervention
Secondary	Technology acceptance	Score on the extended version of the Technology Acceptance Model-2 reflecting th degree to which participants use and intend to use the eCBTi+ (and control intervention) as implemented on e-SPACE. Each process influencing technology acceptance is scored on a 7-point Likert scale.	At 10-12 weeks after the start of the intervention
Secondary	Adherence to treatment	Number of modules completed as a measure of treatment adherence	At 10-12 weeks after the start of the intervention