Effectivness of an Ambulatory Kneipp Therapy Programme as a Multimodal Lifestyle Intervention for Primary Insomnia: A Randomised Controlled Trial

Introduction In Germany, 6-10% of people suffer from clinically relevant sleep disorders, especially among the working population. When these become chronic, they can lead to serious illness and account for a considerable amount of absence from work. Therefore, a Kneipp cure programme for non-organic sleep disorders was developed and tested as a non-drug treatment concept in the health resort of Fussen. Methods Randomised monocentric clinical trial with 5 data collection points (pre/post intervention, 1, 3 and 6 months after intervention). Intervention: 19-day multimodal Kneipp programme (order therapy, hydro- and thermotherapy, exercise therapy). Primary outcome measure: Subjective sleep quality (PSQI total score of 0-21 points:<= 5 points=healthy sleep, PSQI score 5-10 points=poor sleep quality, PSQI total score > 10 points=chronic sleep disorder). Secondary outcome measures: General well-being (WHO 5 Wellbeing Index), chronic stress levels (TICS), dysfunctional beliefs about sleep (DAB-16).Results 96 adults with sleep disorders (mean age 56 years, 83% female) were randomised into an intervention group IG (N=47) and waiting control group WG (N=49). At baseline, there were no relevant group differences (total PSQI scores: IG 11.7 +/- 3.1, WG: 10.6 +/- 3.0). After 1, 3 and 6 months, the proportion of good sleepers increased significantly more in IG versus WG: 34 vs. 10% after 1 month, 40 vs. 12% after 3 months and 28 vs. 14% after 6 months. After 1, 3 and 6 months, the mean PSQI total score decreased significantly more in IG than in WG: - 4.44 points vs. - 1.14 points after 1 month (p=0.001), - 4.19 points vs. - 1.14 points after 3 months (p=0.014]) and - 3.53 points vs. - 1.28 points after 6 months (p=0.111). The IG achieved a clinically relevant reduction in the PSQI score of minus 3 points at all measurement points in the follow-up. Similar positive effects were seen in IG regarding general well-being, chronic stress level and dysfunctional sleep beliefs. Conclusion The outpatient multimodal Kneipp programme achieved significant improvements in sleep quality and well-being as well as a reduction in chronic stress in adults with non-organic sleep disorders. The sustainability of the effects beyond 6 months would have to be investigated in further studies.