This project aims to elucidate whether CBCTi changes symptom severity or even remission of anxiety disorders as compared with a delayed-start control group. The investigators will use a delayed-start randomized controlled trial in a cohort of individuals with anxiety and insomnia (N=98) to compare the effects of an online therapist-guided cognitive behavioural and circadian therapy for insomnia versus control on overnight emotion regulation and mental health outcomes.
The project will involve at-home assessments and in-lab visits. At-home assessment involves recording sleep and circadian rhythm measures with wearables and daily diaries. Participants will be invited to perform two sleep studies and neuroimaging sessions to investigate the effects of CBCTi on neuroimaging and psychophysiological markers of overnight regulation of emotional distress.
(A or B) and (C) A. Diagnosis of insomnia disorder (DSM-5-TR) B. Insomnia Severity Index (ISI) score ≥ 10 C. Generalized Anxiety Disorder (GAD-7) score ≥ 10
All sexes and genders.
Between 18 and 45 years of age.
Able to provide informed consent.
Current or history of neurological disorders (e.g., stroke, brain injury).
Current or history of bipolar disorder, psychosis, or moderate to severe obsessive-compulsive disorder.
Current uncontrolled mental health disorders requiring specialist care, other than major depression and anxiety disorders.
Centrally active agents or presence of medical condition that may affect participation.
Parallel
Immediate CBCTi
BehavioralThis intervention will be immediately accessible to the CBCTi group. The program is composed of weekly online modules that include written information and interactive components such as schematics, images, videos, and questions. The content of the modules follows traditional and validated cognitive-behavioural therapy for insomnia protocols including sleep education, behavioural strategies (e.g., stimulus control, bedtime retraining, sleep hygiene), cognitive restructuration approaches (e.g., thought reappraisal, imagery, mindfulness), and relaxation practices (progressive muscle relaxation and autogenic training). In addition, further content aims to stabilize and amplify circadian rhythmicity through light exposure in the morning, daytime moderate physical activity, and evening time warm baths. Participants complete daily sleep diaries throughout the intervention.
Delayed CBCTi
BehavioralThis intervention will be accessible after a waiting period of 2 months (i.e, delayed start). The program is composed of weekly online modules that include written information and interactive components such as schematics, images, videos, and questions. The content of the modules follows traditional and validated cognitive-behavioural therapy for insomnia protocols including sleep education, behavioural strategies (e.g., stimulus control, bedtime retraining, sleep hygiene), cognitive restructuration approaches (e.g., thought reappraisal, imagery, mindfulness), and relaxation practices (progressive muscle relaxation and autogenic training). In addition, further content aims to stabilize and amplify circadian rhythmicity through light exposure in the morning, daytime moderate physical activity, and evening time warm baths. Participants complete daily sleep diaries throughout the intervention.
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)
Anxiety Disorder diagnosis
Clinician-diagnosed anxiety disorder in accordance with the DSM-5-TR using the Mini-International Neuropsychiatric Interview
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)
EEG sleep efficiency (SE - %)
Mean SE derived from at-home sleep recordings (total sleep time/time in bed\*100)
EEG total sleep time (TST - minutes)
Mean TST derived from at-home sleep recordings
EEG wake duration (minutes)
Mean wake after sleep onset (WASO) derived from at-home sleep recordings
Sleep electroencephalographic (EEG) spectral power
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.
Sleep electroencephalographic (EEG) neuro-oscillatory coupling
derived from PSG recordings in-lab - phase-amplitude coupling measures (modulation index, preferred phase)
Functional connectivity patterns in resting-state brain networks
measured by network-wise dual-regression independent component analysis (FMRIB FSL) with the whole-brain voxel-wise connectivity strength is the dependent variable
EEG sleep-related brain oscillations (characteristics)
EEG neurophysiological events derived from PSG recordings in-lab : density, duration, peak frequency, amplitude, number
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Woolcock Institute of Medical Research
Lead sponsor
Macquarie University, Australia
Collaborator
