Insomnia Disorder Clinical Trial
— SLEEPexpertOfficial title:
Become Your Own SLEEPexpert: a Behavioral Treatment Program for Insomnia in Patients With Psychiatric Disorders
Comorbid insomnia represents a frequent health problem in patients with severe mental disorders, and cognitive behavioral therapy for insomnia (CBT-I) has been identified as the first line treatment. However, CBT-I has not sufficiently been implemented in acute psychiatry settings. Rather, patients are often overtreated with benzodiazepines or benzodiazepine receptor agonists, related to adverse effects and the risk of tolerance and dependency. This work aims to empower patients with severe mental disorders to take care of their own sleep health based on a pragmatic behavioral treatment program ("Become your own SLEEPexpert"). Implementation research strategies in collaboration with patients and health care providers were used to adaptat CBT-I components to the needs of psychiatric inpatients. Evidence for feasibility in an acute hospital setting and preliminary evidence for efficacy has been shown. ln the proposed project, the investigators aim to compare treatment as usual (TAU) + SLEEPexpert to TAU + sleep monitoring in a pilot randomized controlled trial. The objective is to target sleep to improve mental health and to investigate the efficacy of the SLEEPexpert programme for the improvement of sleep and mental health. Given the high burden of comorbid insomnia in psychiatry, the investigators believe that the presented work is of interest to basic scientists and clinicians and, potentially, of heightened public health relevance.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 years or older - Documented diagnosis of acute insomnia, i.e. insomnia criteria according to ICD-10 for at least 2 weeks - Insomnia Severity Index (ISI) total score = 8, equivalent to relevant insomnia - Inpatient in one of the two participating psychiatric wards in the UPD Bern - Ability to understand the aims and procedures of the study - Willingness to participate and ability to provide written informed consent Exclusion Criteria: - Incabability of judgement - Inability to participate in a low-threshold behavioral treatment program, e.g. due to severe cognitive impairment or high symptom severity precluding participation (e.g., severe catatonic symptoms, massive hallucinations, acute endangerment to self or others, involuntary commitment). Note that the named symptoms will lead to exclusion only if they lead to inability to give informed consent or an inability to participate in the program. Excluded patients will be re-assessed regularly and included if symptoms improve and participation is possible at a later point in time. |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital of Psychiatry and Psychotherapy | Bern |
Lead Sponsor | Collaborator |
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University of Bern |
Switzerland,
Ellis JG, Gehrman P, Espie CA, Riemann D, Perlis ML. Acute insomnia: current conceptualizations and future directions. Sleep Med Rev. 2012 Feb;16(1):5-14. doi: 10.1016/j.smrv.2011.02.002. Epub 2011 May 18. — View Citation
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146. — View Citation
Gagnon C, Belanger L, Ivers H, Morin CM. Validation of the Insomnia Severity Index in primary care. J Am Board Fam Med. 2013 Nov-Dec;26(6):701-10. doi: 10.3122/jabfm.2013.06.130064. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory Outcome: Change in Beck Depression Inventory (BDI) | Measurement of the severity of depressive symptoms (scores from 0 to 63 with higher values indicative for more severe depressive symptoms). | change from time point T0 (study start) to T2 (week 2) and T4 (week26) | |
Primary | Change in Insomnia Severity Index (ISI) | The Insomnia Severity Index (ISI) is a valid, reliable and change-sensitive self-rating questionnaire that is widely used as an outcome measure in clinical trials in insomnia research (scores from 0 to 28 with higher values indicative for more severe insomnia). | change from time point T0 (study start) to T1 ( week 1),T2(week2), T3 (week12), T4 (week26) | |
Secondary | Change in Brief Symptom Inventory (BSI) 18-items | The investigators chose the Brief Symptom Inventory, 18 items (BSI) because it is an efficient measure of general mental health. In this study, patients will suffer from different mental disorders including but not limited to depression, psychosis, anxiety and substance abuse.). A general measure, beyond the severity of specific disorders, is thus needed to picture changes in general mental health (scores from 0 to 72 with higher values indicative of a higher symptom severity). | change from time point T0 (study start) to T2 (week 2) and T4 (week26) |
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