Insomnia ChronicRestlessNCT06567210
The Effects of Insomnia Treatment on Overnight Regulation of Emotional Memories and Risk for Mental Disorders
A study testing Immediate CBCTi and Delayed CBCTi in people with Insomnia Chronic and Anxiety, run by Woolcock Institute of Medical Research at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Insomnia Chronic, Anxiety
- What is being tested?
- Immediate CBCTi and Delayed CBCTi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Jan 2026to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Aurore Perrault, PhD contact
Australia1 site, 1 recruiting
- Recruiting
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, 2109
Rick Wassing, PhD, 0298502663, rick.wassing@woolcock.org.au
Greg Kaplan, A/Prof, 0298053232, grigori.kaplan@woolcock.org.au
About this study
Official title: A Delayed-start Randomized Controlled Trial Comparing the Effects of Online Therapist-guided Cognitive Behavioural and Circadian Therapy for Insomnia Versus Control on Overnight Emotion Regulation and Mental Health Outcomes
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.
Read the 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.
- Conditions
- Insomnia Chronic, Anxiety
- Being tested
- Immediate CBCTi, Delayed CBCTi
- Keywords
- insomnia, anxiety, online cognitive behavioral and circadian therapy for insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate CBCTiBehavioural
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.
Delayed CBCTiBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate CBCTi | Experimental | Immediate 8-weeks online therapist-guided CBCTi including weekly online modules. Guidance is provided via scheduled and ad hoc communications (e.g., email, messaging, telehealth) between the participant and a clinician/physician Receives: Behavioral: Immediate CBCTi |
| Delayed-start control | Other | Participants in the delayed-start control group will not receive any active intervention during two months but will be offered the same therapist-guided CBCTi program thereafter. Receives: Behavioral: Delayed CBCTi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 months, 4 months, 12 months
Anxiety Disorder diagnosis
Clinician-diagnosed anxiety disorder in accordance with the DSM-5-TR using the Mini-International Neuropsychiatric Interview
Measured: 2 months, 4 months, 12 months
Secondary outcomes (18)
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)
Measured: 2 months, 4 months, 12 months
EEG sleep efficiency (SE - %)
Mean SE derived from at-home sleep recordings (total sleep time/time in bed*100)
Measured: 2 months, 4 months, 12 months
EEG total sleep time (TST - minutes)
Mean TST derived from at-home sleep recordings
Measured: 2 months, 4 months, 12 months
EEG wake duration (minutes)
Mean wake after sleep onset (WASO) derived from at-home sleep recordings
Measured: 2 months, 4 months, 12 months
EEG sleep onset latency (SOL - minutes)
Mean SOL derived from at-home sleep recordings
Measured: 2 months, 4 months, 12 months
EEG sleep stages (%)
Mean time spent in sleep stages (per total sleep period) derived from at-home sleep recordings
Measured: 2 months, 4 months, 12 months
Actigraphy sleep efficiency (%)
Mean SE derived from actigraphy recording (total sleep time/time in bed*100)
Measured: 2 months, 4 months, 12 months
Actigraphy total sleep duration (minutes)
Mean TST derived from actigraphy recordings
Measured: 2 months, 4 months, 12 months
Actigraphy wake duration (minutes)
Mean WASO derived from actigraphy recordings
Measured: 2 months, 4 months, 12 months
Actigraphy sleep onset latency (minutes)
Mean SOL derived from actigraphy recordings
Measured: 2 months, 4 months, 12 months
7-days light exposure (lux)
derived from at-home continuous light recording during the day
Measured: 2 months, 4 months, 12 months
Hour of Dim-Light Melatonin Onset (HDLMO - hour)
derived from at-home collection of saliva samples
Measured: 2 months
3-days distal-proximal skin-temperature gradients (DPG)
derived from at-home collection of continuous skin temperature (4 locations)
Measured: 2 months, 4 months, 12 months
Self-reported sleep duration (min)
Mean TST derived from sleep diaries
Measured: 2 months, 4 months, 12 months
Self-reported wake duration (min)
Mean WASO derived from sleep diaries
Measured: 2 months, 4 months, 12 months
Self-reported sleep onset latency (min)
Mean SOL derived from sleep diaries
Measured: 2 months, 4 months, 12 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)
Measured: 2 months, 4 months, 12 months
Sleep misperception index (SPI - %)
SPI derived from subjective TST and objective TST (Subj/Obj*100)
Measured: 2 months, 4 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start6 Jan 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Delayed-start randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Woolcock Institute of Medical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Macquarie University, Australia
- Responsible party
- Sponsor
- Investigators
- Rick Wassing, PhD, Principal investigator, Woolcock Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567210
- Sponsor's protocol ID
- 14308
- Other IDs
- 227100/Z/23/Z, GNT1196636
- Acronym
- Restless
- Status last verified
- Nov 2025
- First submitted
- 18 Jul 2024
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All study team members have access to the dataset. Other Woolcock-affiliated staff may also request access to the non-identifiable dataset, which will be considered by the principal investigator and co-investigators. A copy of the non-identifiable dataset may be requested by academic collaborators not affiliated with the Woolcock through a data request form, which outlines the investigators, aims and hypotheses, data to be included, a statistical analysis plan, ethics approval, and security measures.
Publications
Hertenstein E, Feige B, Gmeiner T, Kienzler C, Spiegelhalder K, Johann A, Jansson-Frojmark M, Palagini L, Rucker G, Riemann D, Baglioni C. Insomnia as a predictor of mental disorders: A systematic review and meta-analysis. Sleep Med Rev. 2019 Feb;43:96-105. doi: 10.1016/j.smrv.2018.10.006. Epub 2018 Nov 16.
PubMed 30537570Taylor DJ, Pruiksma KE. Cognitive and behavioural therapy for insomnia (CBT-I) in psychiatric populations: a systematic review. Int Rev Psychiatry. 2014 Apr;26(2):205-13. doi: 10.3109/09540261.2014.902808.
PubMed 24892895Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, Espie CA, Garcia-Borreguero D, Gjerstad M, Goncalves M, Hertenstein E, Jansson-Frojmark M, Jennum PJ, Leger D, Nissen C, Parrino L, Paunio T, Pevernagie D, Verbraecken J, Weess HG, Wichniak A, Zavalko I, Arnardottir ES, Deleanu OC, Strazisar B, Zoetmulder M, Spiegelhalder K. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017 Dec;26(6):675-700. doi: 10.1111/jsr.12594. Epub 2017 Sep 5.
PubMed 28875581Leerssen J, Lakbila-Kamal O, Dekkers LMS, Ikelaar SLC, Albers ACW, Blanken TF, Lancee J, van der Lande GJM, Maksimovic T, Mastenbroek SE, Reesen JE, van de Ven S, van der Zweerde T, Foster-Dingley JC, Van Someren EJW. Treating Insomnia with High Risk of Depression Using Therapist-Guided Digital Cognitive, Behavioral, and Circadian Rhythm Support Interventions to Prevent Worsening of Depressive Symptoms: A Randomized Controlled Trial. Psychother Psychosom. 2022;91(3):168-179. doi: 10.1159/000520282. Epub 2021 Dec 6.
PubMed 34872087Christensen H, Batterham PJ, Gosling JA, Ritterband LM, Griffiths KM, Thorndike FP, Glozier N, O'Dea B, Hickie IB, Mackinnon AJ. Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): a randomised controlled trial. Lancet Psychiatry. 2016 Apr;3(4):333-41. doi: 10.1016/S2215-0366(15)00536-2. Epub 2016 Jan 28.
PubMed 26827250Wassing R, Lakbila-Kamal O, Ramautar JR, Stoffers D, Schalkwijk F, Van Someren EJW. Restless REM Sleep Impedes Overnight Amygdala Adaptation. Curr Biol. 2019 Jul 22;29(14):2351-2358.e4. doi: 10.1016/j.cub.2019.06.034. Epub 2019 Jul 11.
PubMed 31303489Wassing R, Schalkwijk F, Lakbila-Kamal O, Ramautar JR, Stoffers D, Mutsaerts HJMM, Talamini LM, Van Someren EJW. Haunted by the past: old emotions remain salient in insomnia disorder. Brain. 2019 Jun 1;142(6):1783-1796. doi: 10.1093/brain/awz089.
PubMed 31135050Lancee J, van Straten A, Morina N, Kaldo V, Kamphuis JH. Guided Online or Face-to-Face Cognitive Behavioral Treatment for Insomnia: A Randomized Wait-List Controlled Trial. Sleep. 2016 Jan 1;39(1):183-91. doi: 10.5665/sleep.5344.
PubMed 26414893Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
PubMed 11438246Berntsen D, Hoyle RH, Rubin DC. The Autobiographical Recollection Test (ART): A Measure of Individual Differences in Autobiographical Memory. J Appl Res Mem Cogn. 2019 Sep;8(3):305-318. doi: 10.1016/j.jarmac.2019.06.005. Epub 2019 Jul 26.
PubMed 31700775
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Delayed-start Randomized Controlled Trial Comparing the Effects of Online Therapist-guided Cognitive Behavioural and Circadian Therapy for Insomnia Versus Control on Overnight Emotion Regulation and Mental Health Outcomes
- ClinicalTrials.gov ID
- NCT06567210
- Acronym / sponsor ID
- Restless / 14308
- Conditions
- Insomnia Chronic, Anxiety
- Keywords
- insomnia, anxiety, online cognitive behavioral and circadian therapy for insomnia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Woolcock Institute of Medical ResearchUniversity, hospital or other
- Collaborators
- Macquarie University, Australia
- Study start
- 6 Jan 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Delayed-start randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Immediate CBCTi | Experimental | Behavioral: Immediate CBCTiImmediate 8-weeks online therapist-guided CBCTi including weekly online modules. Guidance is provided via scheduled and ad hoc communications (e.g., email, messaging, telehealth) between the participant and a clinician/physician |
| Delayed-start control | Other | Behavioral: Delayed CBCTiParticipants in the delayed-start control group will not receive any active intervention during two months but will be offered the same therapist-guided CBCTi program thereafter. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate CBCTiThis 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. | Behavioural | Immediate CBCTi |
| Delayed CBCTiThis 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. | Behavioural | Delayed-start control |
Primary outcome
General Anxiety Disorder-7 (GAD-7) score
Time frame: 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
Time frame: 2 months, 4 months, 12 months
Clinician-diagnosed anxiety disorder in accordance with the DSM-5-TR using the Mini-International Neuropsychiatric Interview
18 secondary outcomes
Insomnia Severity Index (ISI) score
Time frame: 2 months, 4 months, 12 months
EEG sleep efficiency (SE - %)
Time frame: 2 months, 4 months, 12 months
EEG total sleep time (TST - minutes)
Time frame: 2 months, 4 months, 12 months
EEG wake duration (minutes)
Time frame: 2 months, 4 months, 12 months
EEG sleep onset latency (SOL - minutes)
Time frame: 2 months, 4 months, 12 months
EEG sleep stages (%)
Time frame: 2 months, 4 months, 12 months
Actigraphy sleep efficiency (%)
Time frame: 2 months, 4 months, 12 months
Actigraphy total sleep duration (minutes)
Time frame: 2 months, 4 months, 12 months
Actigraphy wake duration (minutes)
Time frame: 2 months, 4 months, 12 months
Actigraphy sleep onset latency (minutes)
Time frame: 2 months, 4 months, 12 months
7-days light exposure (lux)
Time frame: 2 months, 4 months, 12 months
Hour of Dim-Light Melatonin Onset (HDLMO - hour)
Time frame: 2 months
3-days distal-proximal skin-temperature gradients (DPG)
Time frame: 2 months, 4 months, 12 months
Self-reported sleep duration (min)
Time frame: 2 months, 4 months, 12 months
Self-reported wake duration (min)
Time frame: 2 months, 4 months, 12 months
Self-reported sleep onset latency (min)
Time frame: 2 months, 4 months, 12 months
Self-reported sleep quality (out of 5)
Time frame: 2 months, 4 months, 12 months
Sleep misperception index (SPI - %)
Time frame: 2 months, 4 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Background: PubMed 30537570Hertenstein E, Feige B, Gmeiner T, Kienzler C, Spiegelhalder K, Johann A, Jansson-Frojmark M, Palagini L, Rucker G, Riemann D, Baglioni C. Insomnia as a predictor of mental disorders: A systematic review and meta-analysis. Sleep Med Rev. 2019 Feb;43:96-105. doi: 10.1016/j.smrv.2018.10.006. Epub 2018 Nov 16.
- Background: PubMed 24892895Taylor DJ, Pruiksma KE. Cognitive and behavioural therapy for insomnia (CBT-I) in psychiatric populations: a systematic review. Int Rev Psychiatry. 2014 Apr;26(2):205-13. doi: 10.3109/09540261.2014.902808.
- Background: PubMed 28875581Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, Espie CA, Garcia-Borreguero D, Gjerstad M, Goncalves M, Hertenstein E, Jansson-Frojmark M, Jennum PJ, Leger D, Nissen C, Parrino L, Paunio T, Pevernagie D, Verbraecken J, Weess HG, Wichniak A, Zavalko I, Arnardottir ES, Deleanu OC, Strazisar B, Zoetmulder M, Spiegelhalder K. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017 Dec;26(6):675-700. doi: 10.1111/jsr.12594. Epub 2017 Sep 5.
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- Individual participant dataSharing planned: No. All study team members have access to the dataset. Other Woolcock-affiliated staff may also request access to the non-identifiable dataset, which will be considered by the principal investigator and co-investigators. A copy of the non-identifiable dataset may be requested by academic collaborators not affiliated with the Woolcock through a data request form, which outlines the investigators, aims and hypotheses, data to be included, a statistical analysis plan, ethics approval, and security measures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aurore Perrault, PhD contact
Rick Wassing, PhD principal investigator
Woolcock Institute of Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate CBCTi and Delayed CBCTi in people with Insomnia Chronic and Anxiety, run by Woolcock Institute of Medical Research at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rick Wassing, PhD (+61 0298502663, rick.wassing@woolcock.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Anxiety Disorder-7 (GAD-7) score (time frame: 2 months, 4 months, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06567210, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.