The Effects of Insomnia Treatment on Overnight Regulation of Emotional Memories and Risk for Mental Disorders
Recruiting · NCT06567210 · Interventional (participants receive a specific treatment) · Lead sponsor: Woolcock Institute of Medical Research
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- (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 criteria
- 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.
Where it is running
1 location listed.
- Woolcock Institute of Medical Research - Macquarie Park, New South Wales, Australia