Status:
COMPLETED
The Efficacy of a Transdiagnostic Sleep and Circadian Intervention for Patients With Mental Disorders and Sleep Problems
Lead Sponsor:
University of Aarhus
Conditions:
Depression
Bipolar Affective Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 disord...
Detailed Description
Sleep problems include insomnia, circadian rhythm disorders, hypersomnia, and inadequate sleep hygiene. Patients suffering from mental illness are more likely to suffer from sleep problems than the ge...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT05406414
Start Date
May 23 2022
End Date
July 31 2024
Last Update
September 30 2025
Active Locations (1)
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1
Mette Kragh
Aarhus C, Denmark, 8000