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New treatment option for Insomnia Chronic
Official title The Effects of Insomnia Treatment on Overnight Regulation of Emotional Memories and Risk for Mental Disorders
ClinicalTrials.gov ID: NCT06567210
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45
You may be able to join if
- (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)...
- All sexes and genders.
- Between 18 and 45 years of age.
- Able to provide informed consent.
- Proficient in English.
You likely can't join if
- x Sleep or circadian disorder other than insomnia (e.g., hypersomnolence, periodic limb movement disorder, advanced or delayed sleep phase disorder...
- 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.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Macquarie Park, New South Wales, Australia
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Macquarie Park, New South Wales, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.