Effects of insomnia treatment on emotional memory and mental health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.