A Parallel-group Randomized Controlled Trial Comparing the Effects of Online Therapist-guided Cognitive Behavioural and Circadian Therapy for Insomnia Versus Control on Emotional Regulation and Risk for Mental Disorders

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This project aims to understand and treat insomnia disorder to prevent depression and anxiety. The investigators will use an experimental parallel two-arm repeated measures randomized controlled trial in a cohort of individuals with insomnia to compare the effects of online therapist-guided cognitive behavioural and circadian therapy for insomnia (CBCTi; N=82) versus control (N=27) on subjective and objective sleep and circadian measures as well as symptom and severity of depression and anxiety. The project will involve at-home assessments.Participants from the CBCTi group will also be invited for two sleep studies and neuroimaging sessions to investigate the effects of CBCTi on neuroimaging and psychophysiological markers of overnight regulation of emotional distress.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 45
Healthy Volunteers: f
View:

• Diagnosis of insomnia disorder (DSM-V-TR) or ISI score ≥ 10.

• All sexes and genders.

• Between 25 and 45 years of age.

• Able to provide informed consent.

• Proficient in English.

Locations
Other Locations
Australia
Woolcock Institute of Medical Research
RECRUITING
Macquarie Park
Contact Information
Primary
Rick Wassing, PhD
rick.wassing@woolcock.org.au
+61 0298502663
Backup
Aurore Perrault, PhD
aurore.perrault@mq.edu.au
Time Frame
Start Date: 2025-03-24
Estimated Completion Date: 2029-06
Participants
Target number of participants: 110
Treatments
Experimental: CBCTi
8-weeks online therapist-guided CBCTi including weekly online modules. Guidance is provided via scheduled and ad hoc communications (e.g., email, messaging, telehealth) between the participant and a clinician/physician
Active_comparator: General sleep information
For 8 weeks, participants will receive assess to general sleep health information and perform daily sleep diaries.
Related Therapeutic Areas
Sponsors
Leads: Woolcock Institute of Medical Research
Collaborators: Macquarie University, Australia

This content was sourced from clinicaltrials.gov