CompletedNot Applicable

The Efficacy of a Transdiagnostic Sleep and Circadian Intervention for Patients With Mental Disorders and Sleep Problems

Denmark88 participantsStarted 2022-05-23

Plain-language summary

The aim of this study is to examine the effect of a non-pharmacological transdiagnostic sleep intervention as add on to standard treatment for bipolar disorder, depression and attention deficit disorder. Our hypothesis is that the intervention will reduce the severity of the sleep problem and increase sleep quality compared to a control group receiving sleep hygiene education.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥18 years * F31 Bipolar disorder, F32 unipolar depression or F90 attention deficit disorder * Insomnia Severity Index (ISI) ≥ 14 (exceeding the threshold for a sleep problem) * Sleep problems for 3 months: 3 times a week at least one of the following: * Sleep onset latency ≥ 30 minutes * Wake after sleep onset ≥ 30 minutes * Total sleep time ≥ 11 hours per day * Displaced circadian rhythm; sleeps earlier than 8 P.M. or later than 02 A.M. * Irregular circadian rhythm; bedtime varies ≥ 3 hours throughout the week Exclusion Criteria: * Acutely increased suicide risk (Central Regions guideline for assessment of suicide risk) * Active substance abuse (F10-19) * The sleep problem can be significantly explained by insufficient treatment of physical * disease affecting sleep (documented in patients electronic journal) * Unstable social situation (does not have a permanent residence) * Shift work (≥ 2 times a week for the last 2 months) * Pregnancy and breast-feeding

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the severity of the sleep problem

Timeframe: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint)

Change in sleep quality.

Timeframe: Is measured at inclusion (baseline/ week 0) and at week 6 (endpoint).

Trial details

NCT IDNCT05406414

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-30

View on ClinicalTrials.gov More Depression trials