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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
Change in Pittsburgh sleep quality index. PSQI scores range from 0 to 21, higher scores mean worse sleep quality.
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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
Change in Sleep Efficiency (SE) from actigraphs. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.
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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
Change in Sleep Latency (SL) from actigraphs. Sleep latency in minutes, greater values mean longer time to fall asleep.
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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
Change in Total Sleep Time (TST) from actigraphs. Total Sleep Time in minutes, greater values mean longer time spent asleep.
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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
Change in Wake After Sleep Onset (WASO) from actigraphs. Wake After Sleep Onset in minutes, greater values mean longer time spent awake.
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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
Change in Sleep Efficiency (SE) from EEG. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.
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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
Change in Sleep Latency (SL) from EEG. Sleep latency in minutes, greater values mean longer time to fall asleep
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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
Change in Total Sleep Time (TST) from EEG. Total Sleep Time in minutes, greater values mean longer time spent asleep.
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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
Change in Wake After Sleep Onset (WASO) from EEG. Wake After Sleep Onset in minutes, greater values mean longer time spent awake.
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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
Change in Slow Wave Activity (SWA) power density from EEG.
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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
Change in Slow Wave Sleep (SWS) from EEG. Slow Wave Sleep in minutes, greater values mean longer time spent in Slow Wave Sleep.
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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
Change in Sleep Efficiency (SE) from sleep diaries. Sleep efficiency ranges from 0 to 100, values closer to 100 mean greater sleep efficiency.
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Subjective sleep measures based on sleep diaries: Sleep Latency
Time frame: 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.
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Subjective sleep measures based on sleep diaries: Total Sleep Time
Time frame: 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.
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Subjective sleep measures based on sleep diaries: Wake After Sleep Onset
Time frame: 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.
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Cognitive performances from the CANTAB: Rapid Visual Information Processing (RVP)
Time frame: 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)].
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Cognitive performances from the CANTAB: Spatial Span (SSP)
Time frame: 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]
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Cognitive performances from the CANTAB: Spatial Working Memory (SWM)
Time frame: 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)].
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Cognitive performances from the CANTAB: Paired Associates Learning (PAL)
Time frame: 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)]
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Cognitive performances from the CANTAB: Pattern Recognition Memory (PRM)
Time frame: 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)].
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Cognitive performances from the CANTAB: Intra-Extra Dimensional Set Shift (IED)
Time frame: 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)
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Cognitive performances from the CANTAB: Stocking of Cambridge (SOC)
Time frame: 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
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Negative emotional bias measured on the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: 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)].
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Memory encoding fMRI activations
Time frame: 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.
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Cognitive performance (classical neuropsychological tests)
Time frame: 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]).
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Cortical thickness measures
Time frame: At baseline, at 24 weeks after the start of the intervention
Change in cortical thickness (mm) in the prefrontal cortex and precuneus.
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Fractional anisotropy
Time frame: At baseline, at 24 weeks after the start of the intervention
Change in fractional anisotropy of the superior longitudinal fasciculus and internal capsule.
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Resting-state measures
Time frame: 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.
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GABA/glutamate ratio from magnetic resonance spectroscopy
Time frame: At baseline, at 24 weeks after the start of the intervention
Change in the GABA/glutamate ratio in the anterior cingulate cortex.
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Treatment-mediated association between changes in sleep and cognition
Time frame: 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
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Satisfaction from System Usability Scale
Time frame: 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%.
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Technology acceptance
Time frame: 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.
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Adherence to treatment
Time frame: At 10-12 weeks after the start of the intervention
Number of modules completed as a measure of treatment adherence