The Efficacy of a Transdiagnostic Sleep and Circadian Intervention for Patients With Mental Disorders and Sleep Problems

Study Overview
=================
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.

Official Title
-----------------
Better Sleep Without Medicine - a Cross-sectoral, Quantitative and Qualitative Study for Adult Patients With Mental Disorders and Sleep Problems

Conditions
-----------------
Depression, Bipolar Affective Disorder, Attention Deficit Disorder

Intervention / Treatment
-----------------
* Behavioral: Transdiagnostic sleep and circadian treatment
* Behavioral: Active waitlist control group


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transdiagnostic sleep and circadian treatment<br>The intervention group receives sleep treatment consisting of 6 sessions of 60 minutes each over 6 weeks. | Behavioral: Transdiagnostic sleep and circadian treatment<br>* 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<br>|
| Active Comparator: Active waitlist control group<br>The control group receives sleep hygiene education | Behavioral: Active waitlist control group<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the severity of the sleep problem | 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. | Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint) | 
| Change in sleep quality. | Measured by Pittsburgh Sleeping Quality Index (PSQI). The score is between 0 and 21, 0 indicating no difficulty and 21 indicating severe difficulties. | Is measured at inclusion (baseline/ week 0) and at week 6 (endpoint). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in well-being | 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. | Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint | 
| Level of personal recovery | 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. | Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint). | 
| Change in readiness to take on a job | 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 | Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint) | 
| Changes in health-related items. | The International EQ-5D-5L questionnaire is applied to estimate quality-adjusted years of life. | Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint) | 
| Change in consumption of sleep medications | Daily use of sedatives and hypnotics will be measured by medication registration use in sleep diaries during the study period. | Is registered daily during the 6 week study period | 
| Changes in sleep efficiency | Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs. | Is measured daily during the 6 week study period. | 
| Changes in sleep latency | Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs. | Is measured daily during the 6 week study period | 
| Changes in sleep nocturnal awakenings | Is calculated based on the participant's registrations in sleep diaries and by measurements from actigraphs. | Is measured daily during the 6 week study period. |