Kalmeda app (mobile CBT-based therapy): RCT behind Germany's DiGA listing
Record details
- Authors: Walter U, Pennig S, Kottmann T, et al.
- Journal / source: PLOS Digital Health (2023)
- Design: RCT
- Sample: 187
- Primary endpoint: Tinnitus Questionnaire
- Randomized: Yes · Sham/placebo-controlled: No · Independent of the manufacturer: No
What this research found
Significant TQ reduction vs control, Cohen d = 1.1 (p<0.001). Kalmeda is permanently listed in the German DiGA registry (#350, permanent since Dec 2021; prescribable, reimbursed) on this basis.
Control was 3-month DELAYED treatment (waitlist-type), which inflates effect sizes vs sham-controlled designs — the d=1.1 is not comparable head-to-head with sham-controlled trials. A 9-month extension RCT was published in JMIR 2025.
Limitations and conflicts of interest
Waitlist-type control; no sham app.
Funding / conflicts: Manufacturer-involved.
Primary sources
Used as evidence for
This is an original summary from the Tinnitus Evidence verified database, checked against the primary source — not a reproduction of the publisher's abstract.