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

NCT06567210 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-11-26

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Immediate 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.

BEHAVIORAL

Delayed 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.

Sponsors & Collaborators

  • Macquarie University, Australia

    collaborator OTHER
  • Woolcock Institute of Medical Research

    lead OTHER

Principal Investigators

  • Rick Wassing, PhD · Woolcock Institute of Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-06
Primary Completion
2029-06-30
Completion
2030-06-30

Countries

  • Australia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06567210 on ClinicalTrials.gov