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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011673
Enrollment
100
Registered
2017-01-27
Start date
2016-01-19
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F51

Interventions

Group 1: Intervention Group: 3-week prevention program based on an outpatient Kneipp therapy including five therapeutic elements (1) lifestyle regulation therapy: seminar “inner balance / healthy slee
8 times, 1.5 hours) and relaxation techniques (yoga 6 times, 1 hour
meditation 9 times, 1 hour), (2) Kneipp applications (Wechselgüsse – body parts are alternately poured with warm and cold water 14 times, 5-10 minutes / hay sack followed by a massage 6 times, 30+20 m
in addition a doctor’s lecture entitled “Diagnosis and treatment of sleep disorders “ (1 hour) Group 2: Participants in the Waiting Control Group had to wait for six months before they took part in t

Sponsors

Lehrstuhl für Public Health und Versorgungsforschung am IBEMedizinische Klimatologie, Versorgungsforschung KurortmedizinLMU München
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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)

Design outcomes

Primary

MeasureTime frame
Sleep Quality (Pittsburgh Sleep Quality Index - PSQI) - pre, post (3 weeks), 1, 3, 6 months follow up

Secondary

MeasureTime frame
pre, post (3 weeks), 1, 3, 6 months: 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 (EuroQol (EQ-5D-5L) general health index) pre, 1, 3, 6 months: Dysfunctional beliefs and attitudes about sleep (Dysfunctional Beliefs About Sleep Scale - DBAS); chronic stress (Trier Inventory for Chronic Stress - TICS) pre, 3, 6 months: health-related behaviour pre, 6 months: number of sick days / vacation days (last 6 months); psychotherapeutic treatment (last 6 months); psychic symptoms (ICD-10-Symptom-Rating - ISR) during the 3-week prevention program: sleep diary

Countries

Germany

Contacts

Public ContactDieter Frisch

Lehrstuhl für Public Health und Versorgungsforschung am IBE, Medizinische Klimatologie / Versorgungsforschung Kurortmedizin, Ludwig-Maximilians Universität

dieter.frisch@med.lmu.de+49 (0)89 2180-78214

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026