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

NCT05408078 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-03-31

No results posted yet for this study

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

Interventions

DEVICE

SLEEPexpert

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.

OTHER

TAU plus sleep monitoring

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

Sponsors & Collaborators

  • University of Bern

    lead OTHER

Principal Investigators

  • Christoph Nissen, Prof.Dr. · University Hospital of Psychiatry and Psychotherapy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2025-11-30
Completion
2025-12-31

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05408078 on ClinicalTrials.gov