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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorWoolcock Institute of Medical Research

About this trial

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 criteria

Qualifiers

(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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Immediate CBCTi
  • Delayed CBCTi

Treatment groups

98 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Woolcock Institute of Medical Research

Lead sponsor

Macquarie University, Australia

Collaborator