Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Trying the Kiso Mind smartphone app for people with schizophrenia spectrum disorders

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

Run by Charite University, Berlin, Germany · NCT07395206 · Data updated 2026-11-12

This study tests whether the Kiso Mind smartphone app is acceptable, practical, and helpful for adults with schizophrenia or schizoaffective disorder alongside their usual care.

More Schizophrenia trials

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment60 (estimated)
SponsorCharite University, Berlin, Germany
Academic / other
Locations1 site (Berlin, State of Berlin)
StatusRecruiting
StartedJanuary 30, 2026
Main results expectedJune 30, 2026
Study endsJune 30, 2026
Registry record updatedMarch 3, 2026
Trial IDNCT07395206 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–65 with an ICD-10 diagnosis of schizophrenia (F20) or schizoaffective disorder (F25), who speak German, can use a smartphone, and are not acutely suicidal or receiving intensive psychotherapy are the intended participants.

Probably not a fit

People without a smartphone, with acute heavy substance abuse, serious neurological damage, active suicidality, current electroconvulsive therapy, or who are in intensive psychotherapy are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, parallel-group pilot trial comparing access to the Kiso Mind smartphone app plus treatment-as-usual (TAU) versus TAU alone over 12 weeks. Participants diagnosed with ICD-10 schizophrenia (F20) or schizoaffective disorder (F25) complete baseline and 12-week self-report and rater-based assessments, and a subset in the app arm take part in a qualitative interview. Eligibility screening and clinician ratings are done centrally via video by research associates at Charité Berlin, and randomization is handled independently in Hamburg. The study aims to recruit about 60–80 participants across Germany to test acceptability, feasibility, and preliminary outcomes.

Why it matters

Potential benefit: If successful, the app could offer accessible, smartphone-based support to help people with schizophrenia manage symptoms and daily functioning alongside standard care.

How similar studies have gone: Prior pilot studies of smartphone apps for psychotic disorders have shown feasibility and some symptom or functioning improvements in small samples, but robust large-scale evidence remains limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

* 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's running

  • Charité - Universitätsmedizin Berlin
    Berlin, State of Berlin, Germany
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.