The Effects of Insomnia Treatment on Overnight Regulation of Emotional Memories and Risk for Mental Disorders
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Diagnosis of insomnia disorder (DSM-V-TR) or ISI score ≥ 10.
- All sexes and genders.
- Between 25 and 45 years of age.
- Able to provide informed consent.
- Proficient in English.
Exclusion criteria
- 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 STOP-BANG high-risk score and/or finger-pulse oximetry oxygen desaturation index (ODI) ≥ 10).
- Any contradictions for MRI (e.g., claustrophobia, presence of metal in body, cochlear implants).
- Current or history of neurological disorders (e.g., stroke, brain injury).
- Current or history of any disorder listed in DSM-V other than major depression and anxiety disorders (post-traumatic stress disorder is excluded).
- 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-week 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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT06567210
Intervention or treatment
BEHAVIORAL: CBCTi
BEHAVIORAL: General sleep information
Conditions
- Insomnia Chronic
- Anxiety
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Woolcock Institute of Medical Research
Select from list below to view details:
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, Australia
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Who is running the clinical trial?
Woolcock Institute of Medical Research
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Immediate CBCTi
| Behavioral: Immediate CBCTi |
OTHER: Delayed-start control
| Behavioral: Delayed CBCTi |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
References
Clinical Trials Gov: The Effects of Insomnia Treatment on Overnight Regulation of Emotional Memories and Risk for Mental DisordersOther trials to consider
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