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

Primary Purpose

Insomnia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cognitive behavioral therapy for sleep, anxiety, and depression
education about healthy nutrition habits and communication in older age
Sponsored by
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring insomnia, cognition, mental health, subjective memory decline, sleep, online CBT, older adults, anxiety, depression, executive functions, electroencephalography, magnetic resonance imaging

Eligibility Criteria

60 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion age 60 years or older at the time of enrolment DSM-5 criteria for insomnia disorder (Sleep Condition Indicator, SCI ≤ 16) subjective memory decline 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, 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 3times/week), or use of alcohol 3x/week for sleep, or use of cannabis (more than once a 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 memory decline.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    online cognitive behavioral therapy for insomnia, anxiety and depression

    online intervention on nutrition and communication in older age

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Insomnia severity index
    Change in Insomnia Severity Index. ISI range from 0 to 28, higher score means more severe insomnia symptoms.
    Subjective cognitive abilities based on the everyday cognition questionnaire
    Change in Everyday cognition Questionnaire (ECog) total score as well as number of items with a score ≥ 3. The ECog comprises 39 items and total score corresponds to the sum of all completed items, divided by the number of items completed; thus, total scores range from 1-4. Higher score means more severe cognitive impairment.
    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.
    Geriatric anxiety index
    Change in Geriatric anxiety index. GAI scores range from 0 to 20 and higher scores mean more severe anxiety symptoms.
    Geriatric depression scale
    Change in Geriatric depression scale. GDS scores range from 0 to 15, higher scores mean more severe depression symptoms.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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
    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.
    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.
    Objective sleep measures based on EEG: Slow Wave Activity
    Change in Slow Wave Activity (SWA) power density from EEG.
    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.
    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.
    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.
    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.
    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.
    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)].
    Cognitive performances from the CANTAB: Spatial Span (SSP)
    Change in Spatial Span [SSP - Forward/Reverse Span Lengths (range: 2-9; bad to good]
    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 - ∞; good to bad)].
    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)]
    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)].
    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)
    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 ∞; longer times may indicate better planning efforts
    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)].
    Memory encoding fMRI activations
    Change in fMRI activation level (arbitrary units) in the hippocampus, temporal lobe and prefrontal cortex during the memory encoding task.
    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]).
    Cortical thickness measures
    Change in cortical thickness (mm) in the prefrontal cortex and precuneus.
    Fractional anisotropy
    Change in fractional anisotropy of the superior longitudinal fasciculus and internal capsule.
    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.
    GABA/glutamate ratio from magnetic resonance spectroscopy
    Change in the GABA/glutamate ratio in the anterior cingulate cortex.
    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
    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%.
    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.
    Adherence to treatment
    Number of modules completed as a measure of treatment adherence

    Full Information

    First Posted
    August 24, 2023
    Last Updated
    September 4, 2023
    Sponsor
    Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06032377
    Brief Title
    Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    August 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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 memory decline. 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: Everyday Cognition [ECog], 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 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 memory decline to a group of good sleepers to have normative values for imaging data.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insomnia
    Keywords
    insomnia, cognition, mental health, subjective memory decline, sleep, online CBT, older adults, anxiety, depression, executive functions, electroencephalography, magnetic resonance imaging

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants with insomnia and subjective memory decline are randomized into 2 groups with a 1:1 allocation ratio, after the pre-treatment assessment. Allocation will be stratified based on a composite mental health score. An assessment post-intervention will occur 10 weeks after the start of the intervention and a follow-up assessment 24 weeks after the start of the intervention. One group will receive the online CBT for sleep and mental health after the baseline assessment and the other group will receive the control intervention. The group receiving the control intervention will access the CBT intervention after completion of the study. A good sleepers group, matched on age and gender, will also be recruited and assessed at baseline only to provide a normative reference group. A subgroup of participants and the good sleepers group will undergo MRI and classical neuropsychological testing at baseline and 24 weeks after the start of the intervention.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    275 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    online cognitive behavioral therapy for insomnia, anxiety and depression
    Arm Type
    Experimental
    Arm Description
    10 self-directed modules of cognitive behavioral therapy for insomnia, anxiety and depression, delivered online, once a week
    Arm Title
    online intervention on nutrition and communication in older age
    Arm Type
    Active Comparator
    Arm Description
    10 self-directed modules on healthy nutrition habits and communication strategies, delivered online, once a week
    Intervention Type
    Behavioral
    Intervention Name(s)
    cognitive behavioral therapy for sleep, anxiety, and depression
    Other Intervention Name(s)
    eCBTi+
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    education about healthy nutrition habits and communication in older age
    Other Intervention Name(s)
    active control
    Intervention Description
    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 Measure Information:
    Title
    Insomnia severity index
    Description
    Change in Insomnia Severity Index. ISI range from 0 to 28, higher score means more severe insomnia symptoms.
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Subjective cognitive abilities based on the everyday cognition questionnaire
    Description
    Change in Everyday cognition Questionnaire (ECog) total score as well as number of items with a score ≥ 3. The ECog comprises 39 items and total score corresponds to the sum of all completed items, divided by the number of items completed; thus, total scores range from 1-4. Higher score means more severe cognitive impairment.
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Objective cognitive performance based on a composite score for executive functions from the CANTAB
    Description
    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.
    Time Frame
    At baseline and at 24 weeks after the start of the intervention
    Title
    Geriatric anxiety index
    Description
    Change in Geriatric anxiety index. GAI scores range from 0 to 20 and higher scores mean more severe anxiety symptoms.
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Geriatric depression scale
    Description
    Change in Geriatric depression scale. GDS scores range from 0 to 15, higher scores mean more severe depression symptoms.
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Secondary Outcome Measure Information:
    Title
    Sleep quality based on the Pittsburgh sleep quality index
    Description
    Change in Pittsburgh sleep quality index. PSQI scores range from 0 to 21, higher scores mean worse sleep quality.
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Objective sleep measures based on actigraphy: Sleep Efficiency
    Description
    Change in Sleep Efficiency (SE) from actigraphs. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Objective sleep measures based on actigraphy: Sleep Latency
    Description
    Change in Sleep Latency (SL) from actigraphs. Sleep latency in minutes, greater values mean longer time to fall asleep.
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Objective sleep measures based on actigraphy: Total Sleep Time
    Description
    Change in Total Sleep Time (TST) from actigraphs. Total Sleep Time in minutes, greater values mean longer time spent asleep.
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Objective sleep measures based on actigraphy: Wake After Sleep Onset
    Description
    Change in Wake After Sleep Onset (WASO) from actigraphs. Wake After Sleep Onset in minutes, greater values mean longer time spent awake.
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Objective sleep measures based on EEG: Sleep Efficiency
    Description
    Change in Sleep Efficiency (SE) from EEG. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Objective sleep measures based on EEG: Sleep Latency
    Description
    Change in Sleep Latency (SL) from EEG. Sleep latency in minutes, greater values mean longer time to fall asleep
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Objective sleep measures based on EEG: Total Sleep Time
    Description
    Change in Total Sleep Time (TST) from EEG. Total Sleep Time in minutes, greater values mean longer time spent asleep.
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Objective sleep measures based on EEG: Wake After Sleep Onset
    Description
    Change in Wake After Sleep Onset (WASO) from EEG. Wake After Sleep Onset in minutes, greater values mean longer time spent awake.
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Objective sleep measures based on EEG: Slow Wave Activity
    Description
    Change in Slow Wave Activity (SWA) power density from EEG.
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Objective sleep measures based on EEG: Slow Wave Sleep
    Description
    Change in Slow Wave Sleep (SWS) from EEG. Slow Wave Sleep in minutes, greater values mean longer time spent in Slow Wave Sleep.
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Subjective sleep measures based on sleep diaries: Sleep Efficiency
    Description
    Change in Sleep Efficiency (SE) from sleep diaries. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Subjective sleep measures based on sleep diaries: Sleep Latency
    Description
    Change in Sleep Latency (SL) from sleep diaries. Sleep latency in minutes, greater values mean longer time to fall asleep.
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Subjective sleep measures based on sleep diaries: Total Sleep Time
    Description
    Change in Total Sleep Time (TST) from sleep diaries. Total Sleep Time in minutes, greater values mean longer time spent asleep.
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Subjective sleep measures based on sleep diaries: Wake After Sleep Onset
    Description
    Change in Wake After Sleep Onset (WASO) from sleep diaries. Wake After Sleep Onset in minutes, greater values mean longer time spent awake.
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Cognitive performances from the CANTAB: Rapid Visual Information Processing (RVP)
    Description
    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)].
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Cognitive performances from the CANTAB: Spatial Span (SSP)
    Description
    Change in Spatial Span [SSP - Forward/Reverse Span Lengths (range: 2-9; bad to good]
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Cognitive performances from the CANTAB: Spatial Working Memory (SWM)
    Description
    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 - ∞; good to bad)].
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Cognitive performances from the CANTAB: Paired Associates Learning (PAL)
    Description
    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)]
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Cognitive performances from the CANTAB: Pattern Recognition Memory (PRM)
    Description
    Change in Pattern Recognition Memory [PRM - Percent correct immediate/delayed (range: 0-100; bad to good)].
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Cognitive performances from the CANTAB: Intra-Extra Dimensional Set Shift (IED)
    Description
    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)
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Cognitive performances from the CANTAB: Stocking of Cambridge (SOC)
    Description
    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 ∞; longer times may indicate better planning efforts
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Negative emotional bias measured on the Cambridge Neuropsychological Test Automated Battery (CANTAB)
    Description
    Change in Emotional Bias Task (EBT) subscales from the CANTAB [EBT - proportion of trials rated as 'Happy' (range: 0-15, bad to good)].
    Time Frame
    At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Memory encoding fMRI activations
    Description
    Change in fMRI activation level (arbitrary units) in the hippocampus, temporal lobe and prefrontal cortex during the memory encoding task.
    Time Frame
    At baseline, at 24 weeks after the start of the intervention
    Title
    Cognitive performance (classical neuropsychological tests)
    Description
    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]).
    Time Frame
    At baseline, at 24 weeks after the start of the intervention
    Title
    Cortical thickness measures
    Description
    Change in cortical thickness (mm) in the prefrontal cortex and precuneus.
    Time Frame
    At baseline, at 24 weeks after the start of the intervention
    Title
    Fractional anisotropy
    Description
    Change in fractional anisotropy of the superior longitudinal fasciculus and internal capsule.
    Time Frame
    At baseline, at 24 weeks after the start of the intervention
    Title
    Resting-state measures
    Description
    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.
    Time Frame
    At baseline, at 24 weeks after the start of the intervention
    Title
    GABA/glutamate ratio from magnetic resonance spectroscopy
    Description
    Change in the GABA/glutamate ratio in the anterior cingulate cortex.
    Time Frame
    At baseline, at 24 weeks after the start of the intervention
    Title
    Treatment-mediated association between changes in sleep and cognition
    Description
    Mediation estimate of the extent to which exposure to eCBTi+ explains the association between improved sleep and improved cognition
    Time Frame
    At 10-12 weeks and at 24 weeks after the start of the intervention
    Title
    Satisfaction from System Usability Scale
    Description
    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%.
    Time Frame
    At 10-12 weeks after the start of the intervention
    Title
    Technology acceptance
    Description
    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.
    Time Frame
    At 10-12 weeks after the start of the intervention
    Title
    Adherence to treatment
    Description
    Number of modules completed as a measure of treatment adherence
    Time Frame
    At 10-12 weeks after the start of the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion age 60 years or older at the time of enrolment DSM-5 criteria for insomnia disorder (Sleep Condition Indicator, SCI ≤ 16) subjective memory decline 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, 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 3times/week), or use of alcohol 3x/week for sleep, or use of cannabis (more than once a 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 memory decline.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Thien Thanh Dang-Vu, MD PhD
    Phone
    +1 (514) 340-3540
    Ext
    3540
    Email
    tt.dangvu@concordia.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rebecca Robillard, PhD
    Phone
    +1 (613) 722-6521
    Ext
    6279
    Email
    rebecca.robillard@uottawa.ca

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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