The Effects of Insomnia Treatment on Overnight Regulation of Emotional Memories and Risk for Mental Disorders
NCT Number: NCT06567210
Acronym: Restless
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Insomnia Chronic|Depression, Anxiety
Interventions: BEHAVIORAL: CBCTi|BEHAVIORAL: General sleep information
Sponsor: Woolcock Institute of Medical Research
Collaborators: Macquarie University, Australia
Sex: ALL
Age: ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2029-06
Locations: Woolcock Institute of Medical Research, Macquarie Park, New South Wales, 2109, Australia

Summary:
This project aims to understand and treat insomnia disorder to prevent depression and anxiety. The investigators will use an experimental parallel two-arm repeated measures randomized controlled trial in a cohort of individuals with insomnia to compare the effects of online therapist-guided cognitive behavioural and circadian therapy for insomnia (CBCTi; N=82) versus control (N=27) on subjective and objective sleep and circadian measures as well as symptom and severity of depression and anxiety. The project will involve at-home assessments.Participants from the CBCTi group will also be invited for two sleep studies and neuroimaging sessions to investigate the effects of CBCTi on neuroimaging and psychophysiological markers of overnight regulation of emotional distress.

Primary Outcome Measures: Insomnia Severity Index (ISI) score, Self-report measures of insomnia symptoms and severity. ISI consists of 7 Likert-scale questions with a total score ranging from 0 to 28 (with higher scores indicating more severe insomnia), 8 weeks, 8 months, 20 months|Patient Health Questionnaire-9 (PHQ-9) score, Self-report measures of depression symptoms and severity. PHQ-9 consists of 9 Likert-scale questions with a total score ranging from 0 to 27 (with higher scores indicating more severe depression), 8 weeks, 8 months, 20 months|General Anxiety Disorder-7 (GAD-7) score, Self-report measures of anxiety symptoms and severity. GAD-7 consists of 7 Likert-scale questions with a total score ranging from 0 to 21 (with higher scores indicating more severe anxiety), 8 weeks, 8 months, 20 months
Secondary Outcome Measures: EEG sleep efficiency (SE - %), Mean SE derived from at-home sleep recordings (total sleep time/time in bed\*100), 8 weeks, 8 months, 20 months|EEG total sleep time (TST - minutes), Mean TST derived from at-home sleep recordings, 8 weeks, 8 months, 20 months|EEG wake duration (minutes), Mean wake after sleep onset (WASO) derived from at-home sleep recordings, 8 weeks, 8 months, 20 months|EEG sleep onset latency (SOL - minutes), Mean SOL derived from at-home sleep recordings, 8 weeks, 8 months, 20 months|EEG sleep stages (%), Mean time spent in sleep stages (per total sleep period) derived from at-home sleep recordings, 8 weeks, 8 months, 20 months|Actigraphy sleep efficiency (%), Mean SE derived from actigraphy recording (total sleep time/time in bed\*100), 8 weeks, 8 months, 20 months|Actigraphy total sleep duration (minutes), Mean TST derived from actigraphy recordings, 8 weeks, 8 months, 20 months|Actigraphy wake duration (minutes), Mean WASO derived from actigraphy recordings, 8 weeks, 8 months, 20 months|Actigraphy sleep onset latency (minutes), Mean SOL derived from actigraphy recordings, 8 weeks, 8 months, 20 months|7-days light exposure (lux), derived from at-home continuous light recording during the day, 8 weeks, 8 months, 20 months|Hour of Dim-Light Melatonin Onset (HDLMO - hour), derived from at-home collection of saliva samples, 8 weeks, 8 months, 20 months|3-days distal-proximal skin-temperature gradients (DPG), derived from at-home collection of continuous skin temperature (7 locations), 8 weeks, 8 months, 20 months|Self-reported sleep duration (min), Mean TST derived from sleep diaries, 8 weeks, 8 months, 20 months|Self-reported wake duration (min), Mean WASO derived from sleep diaries, 8 weeks, 8 months, 20 months|Self-reported sleep onset latency (min), Mean SOL derived from sleep diaries, 8 weeks, 8 months, 20 months|Self-reported sleep quality (out of 5), Mean sleep quality derived from sleep diaries on a scale from 0 to 4 (very poor sleep to very good sleep), 8 weeks, 8 months, 20 months|Sleep misperception index (SPI - %), SPI derived from subjective TST and objective TST (Subj/Obj\*100), 8 weeks, 8 months, 20 months
Other Outcome Measures: Sleep electroencephalographic (EEG) spectral power (CBCTi-arm only), derived from polysomnographic (PSG) recordings in-lab: absolute and relative spectral power for band frequencies: slow oscillations (0.25-1.25Hz), delta (0.25-4Hz), theta (4.25-8Hz), alpha (8.25-11.75Hz), sigma (12-16Hz), low beta (16.25-19Hz), high beta (19.25-35Hz) for all stages., 8 weeks|Sleep electroencephalographic (EEG) neuro-oscillatory coupling (CBCTi-arm only), derived from PSG recordings in-lab - phase-amplitude coupling measures (modulation index, preferred phase), 8 weeks|Functional connectivity patterns in resting-state brain networks (CBCTi-arm only), measured by network-wise dual-regression independent component analysis (FMRIB FSL) with the whole-brain voxel-wise connectivity strength is the dependent variable, 8 weeks|EEG sleep-related brain oscillations (characteristics) (CBCTi-arm only), EEG neurophysiological events derived from PSG recordings in-lab : density, duration, peak frequency, amplitude, number, 8 weeks|Brain activation during tasks using functional magnetic resonance imaging (CBCTi-arm only), Whole-brain voxel-wise brain activation maps of the blood-oxygen dependent signal response to emotional stimuli during the Karaoke and Autobiography tasks., 8 weeks