Online COgnitive Behavioural Therapy for Sleep and Mental Health for Older Adults With Insomnia and Subjective Cognitive Complaints
- Conditions
- Insomnia
- Interventions
- Behavioral: cognitive behavioral therapy for sleep, anxiety, and depressionBehavioral: education about healthy nutrition habits and communication in older age
- Registration Number
- NCT06032377
- Lead Sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 275
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description online cognitive behavioral therapy for insomnia, anxiety and depression cognitive behavioral therapy for sleep, anxiety, and depression 10 self-directed modules of cognitive behavioral therapy for insomnia, anxiety and depression, delivered online, once a week online intervention on nutrition and communication in older age education about healthy nutrition habits and communication in older age 10 self-directed modules on healthy nutrition habits and communication strategies, delivered online, once a week
- Primary Outcome Measures
Name Time Method Geriatric depression scale At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention Change in Geriatric depression scale. GDS scores range from 0 to 15, higher scores mean more severe depression symptoms.
Objective cognitive performance based on a composite score for executive functions from the CANTAB At baseline and at 24 weeks after the start of the intervention 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.
Insomnia severity index At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention Change in Insomnia Severity Index. ISI range from 0 to 28, higher score means more severe insomnia symptoms.
Subjective cognitive impairment based on cognitive failure questionnaire At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention 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.
Geriatric anxiety index At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention Change in Geriatric anxiety index. GAI scores range from 0 to 20 and higher scores mean more severe anxiety symptoms.
- Secondary Outcome Measures
Name Time Method Objective sleep measures based on actigraphy: Sleep Latency At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention 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 At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention Change in Total Sleep Time (TST) from actigraphs. Total Sleep Time in minutes, greater values mean longer time spent asleep.
Sleep quality based on the Pittsburgh sleep quality index At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention 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 At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention Change in Sleep Efficiency (SE) from actigraphs. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.
Subjective sleep measures based on sleep diaries: Wake After Sleep Onset At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention 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: Intra-Extra Dimensional Set Shift (IED) At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention 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)
Fractional anisotropy At baseline, at 24 weeks after the start of the intervention Change in fractional anisotropy of the superior longitudinal fasciculus and internal capsule.
Objective sleep measures based on actigraphy: Wake After Sleep Onset At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention Change in Wake After Sleep Onset (WASO) from actigraphs. Wake After Sleep Onset in minutes, greater values mean longer time spent awake.
Cognitive performances from the CANTAB: Spatial Working Memory (SWM) At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention Change in Spatial Working Memory \[SWM - Number of times the subject incorrectly revisits a box in which a token has previously been found (range: 0 - ∞; good to bad)\].
Objective sleep measures based on EEG: Sleep Efficiency At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention Change in Sleep Efficiency (SE) from EEG. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.
Subjective sleep measures based on sleep diaries: Sleep Efficiency At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention 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: Total Sleep Time At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention Change in Total Sleep Time (TST) from sleep diaries. Total Sleep Time in minutes, greater values mean longer time spent asleep.
Cognitive performances from the CANTAB: Rapid Visual Information Processing (RVP) At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention 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: Stocking of Cambridge (SOC) At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention 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
Adherence to treatment At 10-12 weeks after the start of the intervention Number of modules completed as a measure of treatment adherence
Objective sleep measures based on EEG: Slow Wave Sleep At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention 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 Latency At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention Change in Sleep Latency (SL) from sleep diaries. Sleep latency in minutes, greater values mean longer time to fall asleep.
Cognitive performances from the CANTAB: Spatial Span (SSP) At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention Change in Spatial Span \[SSP - Forward/Reverse Span Lengths (range: 2-9; bad to good\]
Cognitive performances from the CANTAB: Paired Associates Learning (PAL) At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention Change in Paired Associates Learning \[PAL - Total errors adjusted (range: 0 - 70; good to bad; First attempt memory score (range: 0-20; bad to good)\]
Negative emotional bias measured on the Cambridge Neuropsychological Test Automated Battery (CANTAB) At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention Change in Emotional Bias Task (EBT) subscales from the CANTAB \[EBT - proportion of trials rated as 'Happy' (range: 0-15, bad to good)\].
Resting-state measures At baseline, at 24 weeks after the start of the intervention 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 At baseline, at 24 weeks after the start of the intervention Change in the GABA/glutamate ratio in the anterior cingulate cortex.
Objective sleep measures based on EEG: Sleep Latency At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention 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 At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention 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 At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention 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 At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention Change in Slow Wave Activity (SWA) power density from EEG.
Cognitive performances from the CANTAB: Pattern Recognition Memory (PRM) At baseline, at 10-12 weeks and at 24 weeks after the start of the intervention Change in Pattern Recognition Memory \[PRM - Percent correct immediate/delayed (range: 0-100; bad to good)\].
Treatment-mediated association between changes in sleep and cognition At 10-12 weeks and at 24 weeks after the start of the intervention Mediation estimate of the extent to which exposure to eCBTi+ explains the association between improved sleep and improved cognition
Satisfaction from System Usability Scale At 10-12 weeks after the start of the intervention 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%.
Memory encoding fMRI activations At baseline, at 24 weeks after the start of the intervention 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) At baseline, at 24 weeks after the start of the intervention 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 At baseline, at 24 weeks after the start of the intervention Change in cortical thickness (mm) in the prefrontal cortex and precuneus.
Technology acceptance At 10-12 weeks after the start of the intervention 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.
Trial Locations
- Locations (2)
The Royal's Institute of Mental Health Research (IMHR)
🇨🇦Ottawa, Ontario, Canada
Centre intégré universitaire de santé et de services sociaux du Centre-Sud-de l'Île-de-Montréal. CCSMTL - IUGM
🇨🇦Montréal, Quebec, Canada