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

NCT05408078 | Completed DMC

• 1 other identifier: 2020-01897
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Brief Symptom Inventory (BSI) 18-items

  change from time point T0 (study start) to T2 (week 2) and T4 (week26)

Other Outcomes (1)

• Exploratory Outcome: Change in Beck Depression Inventory (BDI)

  change from time point T0 (study start) to T2 (week 2) and T4 (week26)

Study Arms (2)

Intervention group - Treatment as Usual (TAU) + SLEEPexpert

EXPERIMENTAL

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.

Device: SLEEPexpert

Control group - TAU + sleep monitoring

OTHER

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.

Other: TAU plus sleep monitoring

Interventions

SLEEPexpert DEVICE

SLEEPexpert 1.0 is the first version of an online Program to treat Insomnia. The internet-based self-help platform used for the implementation of CBT-I in this study has been developed by the University of Bern (Prof. Dr. Thomas Berger), has been used successfully in previous trials and has received a CE mark in 2018. The device is intended for patients with mental disorders and insomnia who are treated for mental disorders in a hospital or an outpatient unit. No specific training is needed to operate the application. There is no available clinical research data to date on exactly this product. However, the therapeutic content that is used in this study is based on Cognitive Behavioral Therapy for insomnia (CBT-I). This intervention has been found to be highly effective and without lasting adverse effects in many studies and is recommended for the treatment of insomnia in current clinical guidelines.

Intervention group - Treatment as Usual (TAU) + SLEEPexpert

TAU plus sleep monitoring OTHER

Treatment aus Usual and a Sleep Monitoring App will be used. This is already described in the Arm Section

Control group - TAU + sleep monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Incabability of judgement

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

University Hospital of Psychiatry and Psychotherapy

Bern, Canton of Bern, 3000, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 21596596 BACKGROUND

• 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.

  PMID: 24204066 BACKGROUND

• 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.

  PMID: 17695343 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Christoph Nissen, Prof.Dr.

  University Hospital of Psychiatry and Psychotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study participants and care providers cannot be blinded because they will notice whether they receive / deliver an actual treatment or a monitoring control. Due to the crossover cluster design (randomization of wards to either TAU plus sleep monitoring or TAU plus SLEEPexpert), patients who are on the same ward at the same time will not get in contact with patients who are in the other arm. Thus, contamination due to exchange between patients will be reduced as far as possible. Outcome assessors (interviewers) and data analysts will be blinded. In the respective documents and database entries, patients will be identified with a code. The key for assigning the codes to patients will not be known to the interviewers and data analysts.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This project is a prospective randomized controlled clinical pilot trial with a cluster-crossover design involving two groups: An interventional group (TAU, plus SLEEPexpert) and a control group (TAU plus sleep monitoring).

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: June 7, 2022
• Study Start: November 1, 2021
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)