„Gesunder Schlaf durch Innere OrdnungDevelopment, implementation and evaluation of a 3-week secondary prevention program for people suffering from non-organic insomnia

Not Applicable

• Conditions: F51; Nonorganic sleep disorders

• Registration Number: DRKS00011673
• Lead Sponsor: ehrstuhl für Public Health und Versorgungsforschung am IBEMedizinische Klimatologie, Versorgungsforschung KurortmedizinLMU München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-27
• Study Completion: 2018-04-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Nonorganic sleep disorder (ICD-10 F51) in accordance with the guideline „Unrestorative sleep /Sleep disturbances of the German Association for Sleep Research and Sleep Medicine (Deutsche Gesellschaft für Schlafforschung und Schlafmedizin) (DGSM); being informed about the purpose and contents of the study; written consent is given

Exclusion Criteria

(A) Diseases to be excluded: sleep apnoea Syndrome, restless legs Syndrome, neurodegenerative diseases (Parkinson’s disease, Alzheimer’s disease …), mental diseases, sleep disorders caused by pain, sleep disorders due to organic disease, alcoholism
(B) Drugs to be excluded: sleeping drugs (only when taken regularly, occasional use is permitted), psychotropic drugs, psychostimulating drugs (e.g. amphetamine, Ritalin, …), anti-epileptics
(C) Other exclusion criteria: working in night shift (occasional night duties are allowed)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep Quality (Pittsburgh Sleep Quality Index - PSQI) - pre, post (3 weeks), 1, 3, 6 months follow up

Secondary Outcome Measures

Name	Time	Method
pre, post (3 weeks), 1, 3, 6 months: <br>use of medications, alcohol consumption, nicotine consumption, well-being (World Health Organization 5-item Well-Being Index - WHO-5), health status / health-related quality of life<br>(EuroQol (EQ-5D-5L) general health index)<br>pre, 1, 3, 6 months:<br>Dysfunctional beliefs and attitudes about sleep (Dysfunctional Beliefs About Sleep Scale - DBAS); chronic stress (Trier Inventory for Chronic Stress - TICS)<br>pre, 3, 6 months:<br>health-related behaviour <br>pre, 6 months:<br>number of sick days / vacation days (last 6 months); psychotherapeutic treatment (last 6 months); psychic symptoms (ICD-10-Symptom-Rating - ISR)<br>during the 3-week prevention program:<br>sleep diary<br>