Clinical trial NCT05408013: The Prevalence of Insomnia in Patients With Psychiatric Disorders
Official title: The Prevalence of Insomnia in Patients With Psychiatric Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Insomnia
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Universitätsklinikum Freiburg Klinik für Psychiatrie und Psychotherapie
name: Universitätsklinikum Schleswig-Holstein Klinik für Psychiatrie und Psychotherapie
name: Schlafzentrum Pfalzklinikum Klingenmünster
name: Klinik und Poliklinik für Psychiatrie und Psychotherapie Leipzig
name: Zentralinstitut für Seelische Gesundheit Mannheim
name: Privatklinik Meiringen
name: Universitätsklinik für Psychiatrie und Psychotherapie, PMU Nürnberg
name: LWL-Klinik Paderborn
name: Klinik für Psychiatrie und Psychotherapie der Universität Regensburg
name: Kompetenzzentrum Schlafmedizin Charité - Campus Benjamin Franklin
name: Klinikum Ingolstadt (withdrawal of participation)
First posted: 2022-06-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who suffer from a psychiatric disorder according to the DSM-5 and who are currently treated as inpatients in a psychiatric hospital

Brief summary: The primary aim of the proposed project is to investigate the prevalence of insomnia in patients with psychiatric disorders treated as inpatients in psychiatric hospitals in two study sites in Switzerland and nine study sites in Germany. The secondary aim is to investigate whether there are demographic or disorder specific parameters that influence the prevalence of insomnia in patients with psychiatric disorders.

Detailed description: QUALITY ASSURANCE PLAN \& SOURCE DATA VERIFICATION

For quality assurance the Ethics Committee may visit the research sites. For each study participant, a paper based case report form (CRF) will be maintained. CRFs will be kept current to reflect subject status at each phase during the course of study. Data for statistical analysis will be stored in an electronic database. Data will be transferred manually from the paper CRF to the electronic data base. As for the paper based CRF, the data stored electronically will not contain any personal information by which the participant can be identified. Only trained project personnel will be authorized for entries into the electronic database and authorized persons will be identifiable for every entry they made. Routinely collected data during daily clinical practice will be transferred to the participant CRF (e.g. diagnoses and medication).

DATA DICTIONARY

BASEC, Business Administration System for Ethical Committees CRF, Case report form FOPH, Federal Office of Public Health HRA, Human Research Act HRO, Ordinance on Human

STANDARD OPERATING PROCEDURE The recruitment of the study participants is consecutive. In all study sites, all newly admitted patients will be registered on a list each day. This list will be available for the study physicians. From this list, patients who are visibly not eligible (involuntary stay, under custody) will be deleted. Depending on the capacities of the study physicians, within three days after admission, 1-15 patients will be selected from the patients remaining on the list per day. The selected patients will be asked whether they agree to participate in the study.

The overall project duration will be 12 months starting the 1st of July 2021 until the end of June 2022. The patients will be screened according to the inclusion and exclusion criteria. The study investigator will then hold one session of 20 to 60 minutes with each participant filling out the following questionnaires:

* The study information and the informed consent
* The informed consent about the further use of the patient data
* Demographic data and general patient documentations
* PSQI: Pittsburgh sleep quality index
* ISI: Insomnia severity index
* The Epworth Sleepiness Scale
* SF-12: Short form 12 questionnaire about the subjective health status
* PHQ-9: Patient health questionnaire 9
* Fatigue Severity Screening

Participants will be withdrawn from the study immediately if there are any concerns about the participants' safety. Participants can also choose to withdraw from the study at any time, and are not required to provide their reason for withdrawing from the study. Coded data acquired before withdrawal will be analyzed as described in the participant information sheet.

If a serious event occurs, the research project will be interrupted and the Ethics Committee notified on the circumstances via BASEC within 7 days according to HRO Art. 21 .

SAMPLE SIZE ASSESSMENT \& STATISTICAL ANALYSIS PLAN

In Table 1 in the study protocol which is attached in the documents section, the 95%- confidence intervals for prevalence in the range from 15% (p=0.15) to 25% (p=0.25) can be seen for sample sizes of n= 200, n= 250, n=300 and n= 500 patients. In consideration of the accuracy of the estimation of varying prevalence, the planned study aims to investigate 500 psychiatric inpatients. The named sample size will be sufficient to estimate prevalence rates with sufficient power.

PLAN FOR MISSING DATA Dropouts will be replaced by recruitment of new participants until the target sample size has been achieved.

Eligibility criteria: Inclusion Criteria:

* patients who suffer from a psychiatric disorder according to the DSM-5 and who are currently treated as inpatients in one of these psychiatric hospitals:

  2 swiss study sites: Universitäre Psychiatrische Dienste in Bern, Privatklinik Meiringen.

  9 german study sites: Freiburg, Ingolsatdt, Kiel, Klingenmünster, Leipzig, Mannheim, Nürnberg, Paderborn, Regensburg

Exclusion Criteria:

* Age under 18 years
* involuntary stay at the clinic
* unable to give informed consent

Primary outcomes:
measure: Insomnia Disorder
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Universitäre Psychiatrische Dienste Bern (Upd)
Study officials:
affiliation: Sleep Research in Psychiatry
name: Christoph Nissen, Prof. Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seow LSE, Verma SK, Mok YM, Kumar S, Chang S, Satghare P, Hombali A, Vaingankar J, Chong SA, Subramaniam M. Evaluating DSM-5 Insomnia Disorder and the Treatment of Sleep Problems in a Psychiatric Population. J Clin Sleep Med. 2018 Feb 15;14(2):237-244. doi: 10.5664/jcsm.6942.