The Efficacy of a Transdiagnostic Sleep and Circadian Intervention for Patients With Mental Disorders and Sleep Problems
- Conditions
- DepressionBipolar Affective DisorderAttention Deficit Disorder
- Interventions
- Behavioral: Transdiagnostic sleep and circadian treatmentBehavioral: Active waitlist control group
- Registration Number
- NCT05406414
- Lead Sponsor
- University of Aarhus
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 88
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Transdiagnostic sleep and circadian treatment Transdiagnostic sleep and circadian treatment The intervention group receives sleep treatment consisting of 6 sessions of 60 minutes each over 6 weeks. Active waitlist control group Active waitlist control group The control group receives sleep hygiene education
- Primary Outcome Measures
Name Time Method Change in sleep quality. Is measured at inclusion (baseline/ week 0) and at week 6 (endpoint). Measured by Pittsburgh Sleeping Quality Index (PSQI). The score is between 0 and 21, "0" indicating no difficulty and "21" indicating severe difficulties.
Change in the severity of the sleep problem Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint) Is measured by Insomnia Severity Index. A self-report instrument measuring the patient's perception of insomnia. The scale ranges from 0 to 28. The higher the score the more severe the insomnia.
- Secondary Outcome Measures
Name Time Method Change in well-being Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint Measured on The WHO-5 Well-Being Index (WHO-5). A questionnaire which measures well-being on a scale ranging from 0 to 100, the higher the score the more well-being.
Changes in sleep latency Is measured daily during the 6 week study period Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs.
Changes in sleep nocturnal awakenings Is measured daily during the 6 week study period. Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs.
Change in readiness to take on a job Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint) Measured by the questionnaire, The Work Ability Index. A score of 0 shows the lowest possibility that the person would take on a job, the score 10 is the highest possibility
Change in consumption of sleep medications Is registered daily during the 6 week study period Daily use of sedatives and hypnotics will be measured by medication registration use in sleep diaries during the study period.
Level of personal recovery Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint). Measured by the questionnaire INSPIRE-O. A questionnaire which measures personal recovery on a scale ranging from 5 to 25, the higher the score the more recovery.
Changes in health-related items. Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint) The International EQ-5D-5L questionnaire is applied to estimate quality-adjusted years of life.
Changes in sleep efficiency Is measured daily during the 6 week study period. Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs.
Trial Locations
- Locations (1)
Mette Kragh
🇩🇰Aarhus C, Denmark