The Efficacy of a Transdiagnostic Sleep and Circadian Intervention for Patients With Mental Disorders and Sleep Problems
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Transdiagnostic sleep and circadian treatment The intervention group receives sleep treatment consisting of 6 sessions of 60 minutes each over 6 weeks. |
Behavioral: Transdiagnostic sleep and circadian treatment
The intervention group receives sleep treatment consisting of 6 sessions of 60 minutes each over 6 weeks. The sessions are delivered individually and have the following content:
Assessment and introduction to the sleep diary
Review of sleep diary - agreements on behavior changes and goals.
Information on normal sleep, sleep problems and circadian rhythm
Cognitive techniques
Introduction to relaxation training
Follow-up on goals and plan for prevention relapse of sleep problems
|
| Active Comparator: Active waitlist control group The control group receives sleep hygiene education |
Behavioral: Active waitlist control group
The control group receives sleep hygiene education consisting of a single session in which 10 points of sleep advice are presented. They receive a booklet on how to promote good sleep practice and must work on their own for the next 6 weeks to implement this while waiting for the intervention.
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
Secondary Outcome Measures
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥18 years
-
F31 Bipolar disorder, F32 unipolar depression or F90 attention deficit disorder
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Insomnia Severity Index (ISI) ≥ 14 (exceeding the threshold for a sleep problem)
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Sleep problems for 3 months: 3 times a week at least one of the following:
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Sleep onset latency ≥ 30 minutes
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Wake after sleep onset ≥ 30 minutes
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Total sleep time ≥ 11 hours per day
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Displaced circadian rhythm; sleeps earlier than 8 P.M. or later than 02 A.M.
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Irregular circadian rhythm; bedtime varies ≥ 3 hours throughout the week
Exclusion Criteria:
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Acutely increased suicide risk (Central Regions guideline for assessment of suicide risk)
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Active substance abuse (F10-19)
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The sleep problem can be significantly explained by insufficient treatment of physical
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disease affecting sleep (documented in patients electronic journal)
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Unstable social situation (does not have a permanent residence)
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Shift work (≥ 2 times a week for the last 2 months)
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Pregnancy and breast-feeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mette Kragh | Aarhus C | Denmark | 8000 |
Sponsors and Collaborators
- University of Aarhus
Investigators
- Principal Investigator: Mette Kragh, Department of affective disorders
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ADA_1