Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
All Genders
NCT06567210

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

Led by Woolcock Institute of Medical Research · Updated on 2025-11-26

98

Participants Needed

1

Research Sites

229 weeks

Total Duration

On this page

Sponsors

W

Woolcock Institute of Medical Research

Lead Sponsor

M

Macquarie University, Australia

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of insomnia disorder (DSM-5-TR) or Insomnia Severity Index (ISI) score of 10 or higher
  • Generalized Anxiety Disorder (GAD-7) score of 10 or higher
  • All sexes and genders
  • Age between 18 and 45 years
  • Able to provide informed consent
  • Proficient in English
Not Eligible

You will not qualify if you...

  • Sleep or circadian disorders other than insomnia, including hypersomnolence, periodic limb movement disorder, advanced or delayed sleep phase disorder, or moderate to severe sleep apnea (apnea-hypopnea index 65 15 or oxygen desaturation index 65 10)
  • Current or history of neurological disorders such as stroke or brain injury
  • Current or history of bipolar disorder, psychosis, or moderate to severe obsessive-compulsive disorder
  • Uncontrolled mental health disorders requiring specialist care other than major depression and anxiety disorders
  • Use of centrally active agents or medical conditions affecting participation
  • Pregnancy, actively trying to conceive, or lactating
  • Shift work of at least two shifts per week in the past three months (work between 21:00 and 6:00)
  • Travel across more than three time zones in the past 30 days
  • Unwillingness to learn about potential incidental findings
  • Lack of consent or inability to adhere to study instructions

AI-Screening

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Trial Site Locations

Total: 1 location

1

Woolcock Institute of Medical Research

Macquarie Park, New South Wales, Australia, 2109

Actively Recruiting

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Research Team

R

Rick Wassing, PhD

CONTACT

A

Aurore Perrault, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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