NCT07395206 Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders
| NCT ID | NCT07395206 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Psychosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-01-30 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-01-30 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07395206 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Psychosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07395206 currently recruiting?
Yes, NCT07395206 is actively recruiting participants. Contact the research team at pawel.weinstein@charite.de for enrollment information.
Where is the NCT07395206 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT07395206 clinical trial?
NCT07395206 is sponsored by Charite University, Berlin, Germany. The trial plans to enroll 60 participants.