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

Anxiety Insomnia Chronic

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

Inclusion Criteria5

(A or B) and (C) A. Diagnosis of insomnia disorder (DSM-5-TR) B. Insomnia Severity Index (ISI) score ≥ 10 C. Generalized Anxiety Disorder (GAD-7) score ≥ 10
All sexes and genders.
Between 18 and 45 years of age.
Able to provide informed consent.
Proficient in English.

Exclusion Criteria10

x 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 finger-pulse oximetry oxygen desaturation index (ODI) ≥ 10).
Current or history of neurological disorders (e.g., stroke, brain injury).
Current or history of bipolar disorder, psychosis, or moderate to severe obsessive-compulsive disorder.
Current uncontrolled mental health disorders requiring specialist care, other than major depression and anxiety disorders.
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-day 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.

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.