MedTrace Logo

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

NCT07395206 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-03

No results posted yet for this study

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.

Conditions

  • Psychosis
  • Psychotic Disorders
  • Primary Psychotic Disorders
  • Schizophrenia Spectrum Disorders
  • Schizophrenia
  • Schizoaffective Disorder

Interventions

BEHAVIORAL

Digital: Kiso Mind App

See above.

Sponsors & Collaborators

  • Kiso Health GmbH

    collaborator UNKNOWN

  • Charite University, Berlin, Germany

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-30
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07395206 on ClinicalTrials.gov