Insomnia Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• (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.

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: 2026-01-06
Estimated Completion Date: 2030-06
Participants
Target number of participants: 98
Treatments
Experimental: Immediate CBCTi
Immediate 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
Other: Delayed-start control
Participants in the delayed-start control group will not receive any active intervention during two months but will be offered the same therapist-guided CBCTi program thereafter.
Related Therapeutic Areas
Sponsors
Leads: Woolcock Institute of Medical Research
Collaborators: Macquarie University, Australia

This content was sourced from clinicaltrials.gov