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Search / Trial NCT06567210

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

Launched by WOOLCOCK INSTITUTE OF MEDICAL RESEARCH · Aug 19, 2024

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Insomnia Depression Anxiety Online Cognitive Behavioral And Circadian Therapy For Insomnia

ClinConnect Summary

This clinical trial is studying how treating insomnia can help prevent depression and anxiety. Researchers want to see if a specific online therapy called cognitive behavioral and circadian therapy for insomnia (CBCTi) can improve sleep and emotional well-being in individuals with insomnia. In this study, some participants will receive the therapy, while others will be part of a control group. The trial will include at-home assessments, and those in the therapy group may also take part in sleep studies and brain scans to further understand how their emotional health changes with treatment.

To be eligible for this trial, participants should be between 25 and 45 years old, have a diagnosis of insomnia, and be able to speak and understand English. However, individuals with certain sleep disorders, serious medical conditions, or who are pregnant or nursing cannot participate. If you join the study, you can expect to complete assessments from home and potentially engage in additional testing to explore how the therapy is affecting your sleep and emotional regulation. This trial aims not only to help improve your sleep but also to contribute to a better understanding of how insomnia affects mental health.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Diagnosis of insomnia disorder (DSM-V-TR) or ISI score ≥ 10.
  • All sexes and genders.
  • Between 25 and 45 years of age.
  • Able to provide informed consent.
  • Proficient in English.
  • Exclusion Criteria:
  • 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 STOP-BANG high-risk score and/or finger-pulse oximetry oxygen desaturation index (ODI) ≥ 10).
  • Any contradictions for MRI (e.g., claustrophobia, presence of metal in body, cochlear implants).
  • Current or history of neurological disorders (e.g., stroke, brain injury).
  • Current or history of any disorder listed in DSM-V other than major depression and anxiety disorders (post-traumatic stress disorder is excluded).
  • 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-week 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.

About Woolcock Institute Of Medical Research

The Woolcock Institute of Medical Research is a leading Australian research organization dedicated to advancing the understanding and treatment of respiratory and sleep disorders. Established in Sydney, the Institute combines innovative clinical research with a strong emphasis on translational medicine, aiming to improve patient outcomes through evidence-based practices. With a multidisciplinary team of researchers, clinicians, and scientists, the Woolcock Institute actively collaborates with national and international partners to drive groundbreaking studies and clinical trials, contributing significantly to the global body of knowledge in pulmonary health and sleep medicine.

Locations

Macquarie Park, New South Wales, Australia

Patients applied

0 patients applied

Trial Officials

Rick Wassing, PhD

Principal Investigator

Woolcock Institute of Medical Research

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported