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

Recruiting now · Not applicable

Conditions studied: Psychosis, Psychotic Disorders, Primary Psychotic Disorders, Schizophrenia Spectrum Disorders, Schizophrenia, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT07395206

Run by

Charite University, Berlin, Germany

People needed

60

Starts

2026-01-30

Expected to finish

2026-06-30

Last updated by the study team

2026-03-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ICD-10: F20 Schizophrenia, F25 Schizoaffective Disorder
• Age: 18 - 65 years
• Sufficient German Language Proficiency
• Ability to Use a Smartphone

You may not qualify if…

• Intensive Psychotherapy Protocols (more than one psychotherapy session a month)
• CGI-Score < 3; > 6
• No smartphone
• Neurological Disorders or Brain Damage
• Acute Suicidality
• Acute Heavy Substance Abuse or Addiction
• Current Electroconvulsive Therapy

Where it is running

• Charité - Universitätsmedizin Berlin — Berlin, State of Berlin, Germany (enrolling)

Full record on ClinicalTrials.gov

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