RecruitingNot ApplicableNCT06567210

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

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


Sponsor

Woolcock Institute of Medical Research

Enrollment

98 participants

Start Date

Jan 6, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether treating insomnia (trouble sleeping) helps reduce anxiety and lowers the risk of developing other mental health problems. Researchers want to understand how sleep affects how our brain processes stressful memories overnight. **You may be eligible if:** - You are between 18 and 45 years old - You have been diagnosed with insomnia, OR you score 10 or higher on a standard insomnia questionnaire - You also score 10 or higher on a standard anxiety questionnaire - You speak and read English **You may NOT be eligible if:** - You have another sleep disorder (like sleep apnea, restless legs, or a sleep schedule disorder) - You have a history of stroke, brain injury, bipolar disorder, or psychosis - You have severe OCD or uncontrolled mental health conditions needing specialist care - You are pregnant, trying to conceive, or breastfeeding - You work night shifts at least twice a week - You recently traveled across more than 3 time zones Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALImmediate CBCTi

This intervention will be immediately accessible to the CBCTi group. The program is composed of weekly online modules that include written information and interactive components such as schematics, images, videos, and questions. The content of the modules follows traditional and validated cognitive-behavioural therapy for insomnia protocols including sleep education, behavioural strategies (e.g., stimulus control, bedtime retraining, sleep hygiene), cognitive restructuration approaches (e.g., thought reappraisal, imagery, mindfulness), and relaxation practices (progressive muscle relaxation and autogenic training). In addition, further content aims to stabilize and amplify circadian rhythmicity through light exposure in the morning, daytime moderate physical activity, and evening time warm baths. Participants complete daily sleep diaries throughout the intervention.

BEHAVIORALDelayed CBCTi

This intervention will be accessible after a waiting period of 2 months (i.e, delayed start). The program is composed of weekly online modules that include written information and interactive components such as schematics, images, videos, and questions. The content of the modules follows traditional and validated cognitive-behavioural therapy for insomnia protocols including sleep education, behavioural strategies (e.g., stimulus control, bedtime retraining, sleep hygiene), cognitive restructuration approaches (e.g., thought reappraisal, imagery, mindfulness), and relaxation practices (progressive muscle relaxation and autogenic training). In addition, further content aims to stabilize and amplify circadian rhythmicity through light exposure in the morning, daytime moderate physical activity, and evening time warm baths. Participants complete daily sleep diaries throughout the intervention.


Locations(1)

Woolcock Institute of Medical Research

Macquarie Park, New South Wales, Australia

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NCT06567210


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