Actively Recruiting
Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders
Led by Charite University, Berlin, Germany · Updated on 2026-03-03
60
Participants Needed
1
Research Sites
21 weeks
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
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.
CONDITIONS
Official 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...
- Diagnosed with schizophrenia (F20) or schizoaffective disorder (F25) according to ICD-10
- Aged between 18 and 65 years
- Have sufficient proficiency in German language
- Able to use a smartphone
You will not qualify if you...
- Receiving intensive psychotherapy (more than one session per month)
- Clinical Global Impression (CGI) score below 3 or above 6
- Do not have a smartphone
- Have neurological disorders or brain damage
- Currently experiencing acute suicidality
- Have acute heavy substance abuse or addiction
- Currently undergoing electroconvulsive therapy
AI-Screening
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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.
CONTACT
E
Eric Hahn, PD Dr.
CONTACT
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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