Clinical trial NCT05406414: The Efficacy of a Transdiagnostic Sleep and Circadian Intervention for Patients With Mental Disorders and Sleep Problems
Official title: Better Sleep Without Medicine - a Cross-sectoral, Quantitative and Qualitative Study for Adult Patients With Mental Disorders and Sleep Problems
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Bipolar Affective Disorder
Attention Deficit Disorder
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2022-06-06
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 general population. Sleep problems can aggravate the underlying disorder, cause relapse and suicidal ideation. Sleep problems often persist after the mental disorder is successfully treated. Sleep medication is often used but not recommended for long term use. Non-pharmacological treatment of sleep problems is in demand by patients, but treatment options are few. The present intervention is based on a transdiagnostic manual combining Cognitive Behavioral Therapy for Insomnia with chronotherapy, but more research on the efficacy is warranted.

The aim of this study is to investigate whether the intervention reduces the severity of the sleep problem, increases sleep quality, leads to increased sleep efficiency, reduces sleep latency and awakenings, provides better quality of life, increases personal recovery, provides greater readiness to take on a job or reduces consumption of sleep medication.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the severity of the sleep problem
timeFrame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint)
measure: Change in sleep quality.
timeFrame: Is measured at inclusion (baseline/ week 0) and at week 6 (endpoint).
Secondary outcomes:
measure: Change in well-being
timeFrame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint
measure: Level of personal recovery
timeFrame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint).
measure: Change in readiness to take on a job
timeFrame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint)
measure: Changes in health-related items.
timeFrame: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint)
measure: Change in consumption of sleep medications
timeFrame: Is registered daily during the 6 week study period
measure: Changes in sleep efficiency
timeFrame: Is measured daily during the 6 week study period.
measure: Changes in sleep latency
timeFrame: Is measured daily during the 6 week study period
measure: Changes in sleep nocturnal awakenings
timeFrame: Is measured daily during the 6 week study period.
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Mette Kragh
Study officials:
affiliation: Department of affective disorders
name: Mette Kragh
role: PRINCIPAL_INVESTIGATOR
References: