GET Sleep - stepped care model for the treatment of insomnia

Phase 4

• Conditions: F51.0; G47.0; Nonorganic insomnia; Disorders of initiating and maintaining sleep [insomnias]

• Registration Number: DRKS00021503
• Lead Sponsor: niversitätsklinikum Freiburg, Klinik für Psychiatrie und Psychotherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 347

Inclusion Criteria

Nonorganic insomnia (ICD-10: F51.0) or disorders of initiating and maintaining sleep (insomnias) (ICD-10: G47.0)

Exclusion Criteria

Untreated sleep apnea (ICD-10: G47.3); untreated restless legs syndrome / periodic limb movements in sleep (ICD-10: G25.8); untreated hyperthyroidism; currently ongoing psychotherapy for insomnia; conditions that can get worse by (i)CBT-I (bipolar disorder, ICD-10: F31.x; epilepsy and recurrent seizures, ICD-10: G40.x); diseases or circumstances that threaten the reliable use of internet and mobile-based treatment (e.g. organic, including symptomatic, mental disorders, ICD-10: F00-F09; mental and behavioral disorders due to psychoactive substance use, ICD-10: F10-F19; schizophrenia, schizotypal and delusional disorders, ICD-10: F20-F29), acute suicidal tendency.
The examination of the inclusion and exclusion criteria is carried out exclusively by the general practitioner responsible

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of insomnia measured by the Insomnia Severity Index (ISI) 6 months after completion of the baseline survey (T3)