Anxiety, Insomnia Chronic
Conditions
Keywords
insomnia, anxiety, online cognitive behavioral and circadian therapy for insomnia
Brief summary
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.
Detailed description
This study is a delayed-start randomized controlled trial comparing the effects of online therapist-guided cognitive behavioural and circadian therapy for insomnia (CBCTi) versus control on emotional regulation and mental health outcomes. To be enrolled in the study, the participants are required to complete an online prescreening survey followed by a telephone screening interview with further questions and to verbally explain to participants what is required of them in this study. After an interview screening, the participants will receive a finger-pulse oximeter by mail to screen for the presence of obstructive sleep apnoea (3 nights at-home). The device is then returned by pre-paid mail and the recording is analysed to screen for moderate to severe sleep apnoea (oxygen desaturation index ≥ 10). If eligible, the participant will be invited to the Woolcock Institute for a screening visit. The screening visit starts with a consult with a clinician/physician who performs a medical screening, explains the study, answers questions and addresses concerns, and obtains written informed consent. At the end of the consult, all eligibility criteria have been evaluated and eligible participants are assigned a randomization number i.e., allocated to either the immediate CBCTi-arm or the delayed-start control-arm. The treatment arm consists of an online therapist-guided CBCTi intervention which comprises online sessions to be completed in 8 weeks. Participants in the delayed-start control arm in this study will not receive any active intervention during the first two months but will be offered the same therapist-guided CBCTi program thereafter During the screening visit, participants will be asked to perform in an audio-visual recording while singing along to Waltzing Matilda (karaoke style) and asked to give keywords that relate to at least five negative distressing experiences and an equal number of neutral experiences from the same period. The recording and the keywords will be used to derive the stimuli that are used in the functional MRI tasks (Pre-Post CBCTi). The screening visit is concluded with a demonstration on how to collect data at-home. Both groups will be asked to perform a week of at-home assessment during 4 timepoints: T0 (baseline), T1 (2 months post-baseline), T2 (4 months post-baseline) and T3 (12 months post-baseline). During the week of at-home assessments, the participants complete questionnaires, keep a sleep diary, and wear an actigraphy-watch, and light and temperature sensor (across 7 days). They are also asked to complete at least four overnight polysomnographic recordings using an EEG headband. At Pre and Post-CBCTi only, they also complete a salivary melatonin collection protocol. At Pre and Post-CBCTi (i.e., T0 and T1 for immediate group - T1 and T2 for delayed group) , participants are invited to Macquarie University/Woolcock Institute to undergo overnight sleep studies and neuroimaging sessions. The CBCTi program will be given online via secure platforms and recruitment will primarily be through social media advertisements. The study will be coordinated from the Woolcock Institute of Medical Research, Sydney, Macquarie Park, New South Wales, 2109, Australia.
Interventions
BEHAVIORALImmediate CBCTi
This 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.
BEHAVIORALDelayed CBCTi
This 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.
Sponsors
Macquarie University, Australia
Woolcock Institute of Medical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Researchers responsible for randomization and data-analysis will be blinded to the study arms.
Intervention model description
Delayed-start randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* (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. * Proficient in English.
Exclusion criteria
x Sleep or circadian disorder other than insomnia (e.g., hypersomnolence, periodic limb movement disorder, advanced or delayed sleep phase disorder, moderate to severe sleep apnoea disorder based on previous sleep study with an apnea-hypopnea index ≥ 15 and/or finger-pulse oximetry oxygen desaturation index (ODI) ≥ 10). * 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. * Pregnancy or actively trying to conceive, or lactating. * Shift work for at least 2 shifts per week in the past 3 months (i.e., work between 21:00 and 6:00). * Travel across time zones over 3 hours difference in the previous 30 days (will require a 1-day adjustment period per hour of time zone travelled). * Unwilling to know about potential incidental findings. * No consent or adherence to instructions for any part of the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| General Anxiety Disorder-7 (GAD-7) score | 2 months, 4 months, 12 months | 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 | 2 months, 4 months, 12 months | Clinician-diagnosed anxiety disorder in accordance with the DSM-5-TR using the Mini-International Neuropsychiatric Interview |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EEG sleep onset latency (SOL - minutes) | 2 months, 4 months, 12 months | Mean SOL derived from at-home sleep recordings |
| 7-days light exposure (lux) | 2 months, 4 months, 12 months | derived from at-home continuous light recording during the day |
| Hour of Dim-Light Melatonin Onset (HDLMO - hour) | 2 months | derived from at-home collection of saliva samples |
| 3-days distal-proximal skin-temperature gradients (DPG) | 2 months, 4 months, 12 months | derived from at-home collection of continuous skin temperature (4 locations) |
| Self-reported sleep quality (out of 5) | 2 months, 4 months, 12 months | Mean sleep quality derived from sleep diaries on a scale from 0 to 4 (very poor sleep to very good sleep) |
| Sleep misperception index (SPI - %) | 2 months, 4 months, 12 months | SPI derived from subjective TST and objective TST (Subj/Obj\*100) |
| Self-reported sleep onset latency (min) | 2 months, 4 months, 12 months | Mean SOL derived from sleep diaries |
| Self-reported sleep duration (min) | 2 months, 4 months, 12 months | Mean TST derived from sleep diaries |
| Self-reported wake duration (min) | 2 months, 4 months, 12 months | Mean WASO derived from sleep diaries |
| Insomnia Severity Index (ISI) score | 2 months, 4 months, 12 months | 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 - %) | 2 months, 4 months, 12 months | Mean SE derived from at-home sleep recordings (total sleep time/time in bed\*100) |
| EEG total sleep time (TST - minutes) | 2 months, 4 months, 12 months | Mean TST derived from at-home sleep recordings |
| EEG wake duration (minutes) | 2 months, 4 months, 12 months | Mean wake after sleep onset (WASO) derived from at-home sleep recordings |
| EEG sleep stages (%) | 2 months, 4 months, 12 months | Mean time spent in sleep stages (per total sleep period) derived from at-home sleep recordings |
| Actigraphy sleep efficiency (%) | 2 months, 4 months, 12 months | Mean SE derived from actigraphy recording (total sleep time/time in bed\*100) |
| Actigraphy total sleep duration (minutes) | 2 months, 4 months, 12 months | Mean TST derived from actigraphy recordings |
| Actigraphy wake duration (minutes) | 2 months, 4 months, 12 months | Mean WASO derived from actigraphy recordings |
| Actigraphy sleep onset latency (minutes) | 2 months, 4 months, 12 months | Mean SOL derived from actigraphy recordings |
Other
| Measure | Time frame | Description |
|---|---|---|
| EEG sleep-related brain oscillations (characteristics) | 2 months | EEG neurophysiological events derived from PSG recordings in-lab : density, duration, peak frequency, amplitude, number |
| Brain activation during tasks using functional magnetic resonance imaging | 2 months | Whole-brain voxel-wise brain activation maps of the blood-oxygen dependent signal response to emotional stimuli during the Karaoke and Autobiography tasks. |
| Sleep electroencephalographic (EEG) neuro-oscillatory coupling | 2 months | derived from PSG recordings in-lab - phase-amplitude coupling measures (modulation index, preferred phase) |
| Sleep electroencephalographic (EEG) spectral power | 2 months | 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. |
| Functional connectivity patterns in resting-state brain networks | 2 months | measured by network-wise dual-regression independent component analysis (FMRIB FSL) with the whole-brain voxel-wise connectivity strength is the dependent variable |
Countries
Australia
Contacts
Primary ContactRick Wassing, PhD
Backup ContactAurore Perrault, PhD
Outcome results
None listed