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NCT07395206Recruiting

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

Source: ClinicalTrials.gov · Last updated 3 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
30 Jan 2026
Start date
30 Jan 2026
Primary completion date
30 Jun 2026
Lead sponsor
Charite University, Berlin, Germany
NCT number
NCT07395206

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 30 Jan 2026 to the primary completion date, 30 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current Electroconvulsive Therapy

Other illness

  • Neurological Disorders or Brain Damage

Other

  • Intensive Psychotherapy Protocols (more than one psychotherapy session a month)
  • CGI-Score \< 3; \> 6
  • No smartphone
  • Acute Suicidality
  • Acute Heavy Substance Abuse or Addiction

Who the study is looking for

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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Charité Universitätsmedizin Berlin
Coordinator of this site? Confirm its status
BerlinGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.