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 (Restless)

NCT06567210 NA RECRUITING

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.

Details

Lead sponsor	Woolcock Institute of Medical Research
Phase	NA
Status	RECRUITING
Enrolment	98
Start date	2026-01-06
Completion	2030-06

Conditions

• Insomnia Chronic
• Anxiety

Interventions

• Immediate CBCTi
• Delayed CBCTi

Primary outcomes

• General Anxiety Disorder-7 (GAD-7) score — 2 months, 4 months, 12 months
  Self-report measures of anxiety symptoms and severity. GAD-7 consists of 7 Likert-scale questions with a total score ranging from 0 to 21 (with higher scores indicating more severe anxiety)
• Anxiety Disorder diagnosis — 2 months, 4 months, 12 months
  Clinician-diagnosed anxiety disorder in accordance with the DSM-5-TR using the Mini-International Neuropsychiatric Interview

Countries

Australia