Clinical Trial

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

Study acronym: Restless
Recruiting
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-08-19; most recent amendment 2025-11-20.
Status change: Not Yet Recruiting → Recruiting 2025-03-21
Trial Details
NCT Number NCT06567210
Lead Sponsor Woolcock Institute of Medical Research
Collaborators: Macquarie University, Australia
Conditions Insomnia Chronic, Anxiety
Enrollment 98 participants
Start Date 2026-01-06
Primary Completion 2029-06 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2025-11-26