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The Effects of Insomnia Treatment on Overnight Regulation of Emotional Memories and Risk for Mental Disorders

Key facts

Where
Macquarie Park, AustraliaSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 45 years old?

Source: NCT06567210, who can take part

Where in Australia

  • Woolcock Institute of Medical ResearchMacquarie Park, AustraliaContact: Rick Wassing, PhDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Woolcock Institute of Medical Research
Trial code
NCT06567210
Record updated
26 November 2025
Original description
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.Read full original descriptionShow less

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.

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); 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); 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); Unwilling to know about potential incidental findings; No consent or adherence to instructions for any part of the study protocol.

ClinicalTrials.gov NCT06567210