Become Your Own SLEEPexpert: a Behavioral Treatment Program for Insomnia in Patients With Psychiatric Disorders

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
University Hospital of Psychiatry and Psychotherapy
RECRUITING
Bern
Contact Information
Primary
Christoph Nissen, Prof.Dr
Christoph.Nissen@hcuge.ch
+41 31 930 9545
Backup
Elisabeth Hertenstein, Dr.
Elisabeth.Hertenstein@upd.ch
+41 31 930 9111
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 60
Treatments
Experimental: Intervention group - Treatment as Usual (TAU) + SLEEPexpert
SLEEPexpert is a behavioral programme for insomnia.~The TAU + SLEEPexpert group will receive a specific treatment for insomnia. This treatment will consist of the following three phases:~1. a face-to-face treatment initiation (kick-off) guided by a medical doctor/ psychologist in a group format~2. self-managed implementation of behavioral changes supported by the nursing team (individual brief contact during the week)~3. self-management by the patients, potentially assisted by the Webapplication after discharge from the hospital.
Other: Control group - TAU + sleep monitoring
In addition to TAU, patients in the control group (TAU + sleep monitoring) receive a smartphone app (sleep monitoring). No further interventions will be provided through this app.~TAU comprises standard clinical care, including intensive daily contacts with health care providers on the wards, medical treatment, pharmacotherapy, psychotherapy in individual and group setting, nurse support, additional therapies such as music or ergotherapy and social support, informed by current guidelines for the respective disorder and adapted to individual needs. Of note, no change to any aspects of TAU will be made. Sleep monitoring will consist of daily sleep diary entries with the help of a smartphone app.
Related Therapeutic Areas
Sponsors
Leads: University of Bern

This content was sourced from clinicaltrials.gov