The MindDoc-App is a risk class I medical product according to the Council Directive 93/42/EEC Appendix IX.3 rule 12

 

 

Intended medical purpose

The MindDoc monitoring and self-management application medical device provides continuous long-term sign and symptom monitoring of common mental disorders. This protocol is supplemented by courses and exercises. This enables users to recognize patterns in their symptom trajectories which then can be shared with a mental health care provider and used for self-management.

 MindDoc thus

  • provides users orientation regarding the need to consult a mental health care provider by providing an assessment of the general emotional health. A mental health care provider then can include the summary of the protocols in his overall diagnostic and clinical assessment.
  • enables users to self-manage symptoms and related problems by providing both transdiagnostic and disorder-specific evidence-based courses and exercises which help them to recognize, understand, and cope with signs and symptoms of mental disorders by self-initiating behavior change.

Note:

  • The application explicitly does not replace the diagnosis by a mental health care provider, but can only give orientation on whether to consult a mental health care provider who then can include the results of the medical device in diagnostic processes.
  • The application explicitly does not replace psychotherapy.

Intended users

Patients before, during, or after treatment of mental disorders

  • Age >18

  • All genders

  • General ability to use a smartphone and a web-application (reading, listening)

  • Internet Access

  • Access to a smartphone and a 3rd party Appstore (Apple Appstore, Google Play)

  • no, minimal, mild, and moderate mental disorders

 

The app may not be suitable for individuals with severe mental disorders including organic mental disorders (F0), most substance-related disorders (F1x.0, F1x.2, F1x.3, F1x.4, F1x.5, F1x.6., F1x.7), schizophrenia, schizotypal and delusional disorders (F2), severe depressive episodes (F32.2, F32.2, F33.2, F33.3), bipolar affective disorders (F30, F31, F34.0), dissociative disorders (F44, F48.1), intellectual disabilities and neurodevelopmental disorders (F7, F8).

We declare that the MindDoc monitoring and self-management application meets the provisions of Annex VII of the Council Directive 93/42/EEC for medical devices. Our EU declaration of conformity is issued under the sole responsibility of the manufacturer.

Scientific Background

Digital self-help offers can help to identify one’s own problems and symptoms, lower the inhibition threshold for psychotherapy, and improve communication with therapists. Although they are by no means intended to replace psychotherapy, about one in two users feels slightly better when they use them. A major advantage of purely digital self-help services is that they can reach a large number of people at low cost. Our questions, insights, course content and exercises are developed by psychological psychotherapists and are based on the principles of cognitive-behavioral therapy and its further development. We closely follow the treatment guidelines of the international associations as well as well-evaluated treatment concepts, so that all our content is evidence-based. More information and links to academic research papers can be found here. 

Instruction of use

The most current application’s instruction for use can be downloaded here or be requested as a printed version through the support option within the application (Profile –> “Give feedback”)