Testing the Kiso Mind Smartphone App for Adults 18-65 With Schizophrenia or Schizoaffective Disorder A 12-Week Randomized Pilot Study

What this Trial Is About

Researchers are evaluating the acceptability and feasibility of the Kiso Mind smartphone app as a new digital intervention for people diagnosed with schizophrenia or schizoaffective disorder. This randomized controlled pilot trial compares the use of the Kiso Mind app plus treatment-as-usual TAU with TAU alone. The study aims to explore how well participants accept and can use the app, alongside measuring changes in symptoms and social functioning over 12 weeks. Participants assigned to the experimental group receive access to the Kiso Mind app for 12 weeks. The app offers psychoeducation modules and various psychotherapeutic activities based on cognitive behavioral therapy principles, along with tools like medication reminders, mood tracking, and emergency contacts. Participants in the control group continue with their usual psychiatric care, which typically involves quarterly medication appointments and limited psychotherapy. Throughout the study, participants complete self-report and clinician-rated assessments at the start and end of the 12-week period to measure symptoms, social functioning, self-efficacy, and quality of life. Data are securely stored in a pseudonymized format. A qualitative interview is also conducted with those using the app to gather feedback. The study plans to enroll 60 to 80 participants and is led by Charit University in Berlin, Germany.

Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders