Actively Recruiting
Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders: A Randomized Controlled Pilot Trial
Led by Charite University, Berlin, Germany · Updated on 2026-03-03
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Charite University, Berlin, Germany
Lead Sponsor
K
Kiso Health GmbH
Collaborating Sponsor
AI-Summary
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 Charité University in Berlin, Germany.
CONDITIONS
Brief Title
Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of schizophrenia (F20) or schizoaffective disorder (F25) according to ICD-10
- Age between 18 and 65 years
- Sufficient proficiency in German language
- Ability to use a smartphone
You will not qualify if you...
- Receiving more than one psychotherapy session per month
- Clinical Global Impression (CGI) score less than 3 or greater than 6
- No access to a smartphone
- Neurological disorders or brain damage
- Acute suicidality
- Acute heavy substance abuse or addiction
- Current treatment with electroconvulsive therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit via video interview
Duration - 12 weeks
Participants receive a 12-week digital intervention using the Kiso Mind App, which includes psychoeducation and psychotherapeutic modules based on CBTp principles, as well as supportive functions like medication reminders and mood trackers. Participants in the control group continue treatment as usual.
1 baseline assessment visit and 1 post-treatment clinical interview via video or email
Trial Site Locations
Total: 1 location
1
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany, 10117
Actively Recruiting
Research Team
P
Pawel Weinstein, M.Sc.
E
Eric Hahn, PD Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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