RecruitingNot ApplicableNCT07395206

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

Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders: A Randomized Controlled Pilot Trial


Sponsor

Charite University, Berlin, Germany

Enrollment

60 participants

Start Date

Jan 30, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a mental health smartphone app called Kiso Mind for people with schizophrenia or schizoaffective disorder who are receiving outpatient care. The study looks at whether the app is acceptable to patients, feasible to use in routine care, and shows early signs of improving symptoms or quality of life. The app is designed in German. **You may be eligible if...** - You have a diagnosis of schizophrenia (ICD-10 F20) or schizoaffective disorder (F25) - You are between 18 and 65 years old - You have sufficient German language skills - You own and can use a smartphone **You may NOT be eligible if...** - You are receiving intensive psychotherapy (more than one session per month) - Your symptoms are either very mild or very severe (CGI score outside range 3–6) - You have neurological disorders or brain damage - You are experiencing acute thoughts of suicide - You have acute heavy substance use or addiction - You are currently undergoing electroconvulsive therapy (ECT) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALDigital: Kiso Mind App

See above.


Locations(1)

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

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NCT07395206


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