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Effectiveness of a digital lifestyle management intervention (levidex) to improve quality of life in people with multiple sclerosis: results of a randomized controlled trial

Effectiveness of Levidex in Improving Quality of Life for People with Multiple Sclerosis: Results of a Clinical Trial

Background

Multiple Sclerosis (MS) significantly impacts patients’ quality of life (QoL). Levidex, a digital health application based on cognitive behavioral therapy (CBT) principles, was tested in a randomized controlled trial to examine its effects on MS-related QoL over 6 months.

Methods

Participants with MS were randomly assigned to receive standard care + levidex or standard care with web-adapted material. The primary outcome was MS-related QoL after 6 months, measured by the Hamburg Quality of Life Questionnaire in MS (HAQUAMS).

Results

After 6 months, the group using levidex showed significantly higher MS-related QoL, fewer sick days, and higher levels of daily activities compared to the control group. Safety analyses showed no adverse events and good satisfaction.

Conclusions

Levidex facilitated clinically relevant improvements in MS-related QoL, reduced sick days, and enhanced activity in people with MS over 6 months. It can serve as an effective non-pharmacological adjunctive treatment element to standard care and help improve QoL among people with MS.

Clinical Trials Registration

Registered on 22.09.2020 at the German Clinical Trials Register DRKS00023023.

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