About this trial
The Kiso pilot study is a randomized controlled trial to test the acceptability and feasibility of a novel digital intervention, namely the Kiso Mind smartphone app. A parallel-group design is utilized. Participants either receive access to the Kiso Mind intervention and treatment-as-usual (TAU) in the experimental condition or receive treatment as usual (TAU) in the control condition. The intervention is designed for participants diagnosed with either schizophrenia (F20.0) or schizoaffective disorder (F25.0) according to the ICD-10.
To examine acceptability, feasibility, and preliminary effectiveness, both self-report and rater-based assessments are administered at baseline (T0) and at the end of the 12-week intervention period (post-intervention T1). Lastly, a qualitative interview will be conducted with participants from the experimental condition. The primary outcome of the present study is the acceptability and feasibility of the Kiso Mind app. The secondary outcome consists of general psychopathology, and positive-, negative-, depressive symptoms, as well as social functioning and self-efficacy ratings.
Eligibility criteria
Qualifiers
ICD-10: F20 Schizophrenia, F25 Schizoaffective Disorder
Age: 18 - 65 years
Sufficient German Language Proficiency
Ability to Use a Smartphone
Disqualifiers
Intensive Psychotherapy Protocols (more than one psychotherapy session a month)
CGI-Score < 3; > 6
No smartphone
Neurological Disorders or Brain Damage
Trial design
Treatments tested in this trial
- Digital: Kiso Mind App
Treatment groups
Sponsors and collaborators
Charite University, Berlin, Germany
Lead sponsor
Kiso Health GmbH
Collaborator