Effects of insomnia treatment on emotional memory and mental health
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 study is testing whether a new online therapy for insomnia can help people sleep better and improve their mood to prevent depression and anxiety.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Woolcock Institute of Medical Research Academic / other |
| Locations | 1 site (Macquarie Park, New South Wales) |
| Trial ID | NCT06567210 on ClinicalTrials.gov |
What this trial studies
This project aims to understand and treat insomnia disorder to prevent depression and anxiety. It employs a randomized controlled trial design comparing online therapist-guided cognitive behavioral and circadian therapy for insomnia (CBCTi) with a control group. Participants will undergo at-home assessments and may participate in sleep studies and neuroimaging sessions to evaluate the impact of the intervention on emotional regulation and mental health outcomes. The study will include a thorough screening process to ensure participant eligibility.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25 to 45 with a diagnosis of insomnia disorder.
Not a fit: Patients with other sleep disorders or significant medical conditions that could affect participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the risk of developing depression and anxiety in individuals with insomnia.
How similar studies have performed: Other studies have shown promising results with cognitive behavioral therapies for insomnia, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Macquarie Park, New South Wales
- Woolcock Institute of Medical Research — Macquarie Park, New South Wales, Australia (Recruiting)
Study contacts
- Principal investigator: Rick Wassing, PhD — Woolcock Institute of Medical Research
- Study coordinator: Rick Wassing, PhD
- Email: rick.wassing@woolcock.org.au
- Phone: +61 0298502663
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.