Status:
RECRUITING
The Effects of Insomnia Treatment on Overnight Regulation of Emotional Memories and Risk for Mental Disorders
Lead Sponsor:
Woolcock Institute of Medical Research
Collaborating Sponsors:
Macquarie University, Australia
Conditions:
Insomnia Chronic
Anxiety
Eligibility:
All Genders
18-45 years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- (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
- 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.
Key Trial Info
Start Date :
January 6 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT06567210
Start Date
January 6 2026
End Date
June 1 2030
Last Update
November 26 2025
Active Locations (1)
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1
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, Australia, 2109