Trying the Kiso Mind smartphone app for people 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
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Locations | 1 site (Berlin, State of Berlin) |
| Trial ID | NCT07395206 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Berlin, State of Berlin
- Charité - Universitätsmedizin Berlin — Berlin, State of Berlin, Germany (Recruiting)
Study contacts
- Study coordinator: Pawel Weinstein, M.Sc.
- Email: pawel.weinstein@charite.de
- Phone: 0049 30 450 617 325
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.