NCT05406414Completed
The Efficacy of a Transdiagnostic Sleep and Circadian Intervention for Patients With Mental Disorders and Sleep Problems
Better Sleep Without Medicine - a Cross-sectoral, Quantitative and Qualitative Study for Adult Patients With Mental Disorders and Sleep Problems
Source: ClinicalTrials.gov · Last updated 30 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 88 (actual)
- First submitted
- 1 Jun 2022
- Start date
- May 2022
- Primary completion date
- May 2024
- Lead sponsor
- University of Aarhus
- Diseases
- Bipolar disorder
- NCT number
- NCT05406414
What you commit to
- Study type: Interventional
- Participants enrolled: 88
- From May 2022 to the primary completion date, May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- disease affecting sleep (documented in patients electronic journal)
Other
- 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
- Unstable social situation (does not have a permanent residence)
- Shift work (≥ 2 times a week for the last 2 months)
- Pregnancy and breast-feeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mette Kragh Coordinator of this site? Confirm its status | Aarhus C | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.