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

February 28, 2026 updated by: Kerem Böge, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There are multiple ways to join the present study. Healthcare workers at different institutions across Germany identify eligible participants and invite them to participate in the study. Those institutions include inpatient wards and outpatient facilities. Moreover, participants can join via multiple channels, including online channels and advertising such as social media, etc. Eligibility screenings and baseline clinician ratings are conducted centrally by research associates (psychologists) at Charité Universitätsmedizin Berlin via a video interview. After confirming the inclusion criteria, participants will be randomised and receive the self-report section of the baseline assessment. Randomization is conducted independently by research associates at the Universitätsklinikum Hamburg-Eppendorf in Hamburg. After 12 weeks, participants complete a clinical interview to assess the rater-based section of the post-treatment assessment and receive the self-report section via email.

All participant data is stored in a pseudonymized format. No clinical data is saved in combination with clinical data. The participants have the right to access their data and the right to claim deletion of their data. Data are stored in an online database, accessible only to researchers involved in the study.

Due to the exploratory nature of this study, we aim to recruit 60 to 80 participants in total until June.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • State of Berlin
      • Berlin, State of Berlin, Germany, 10117
        • Recruiting
        • Charité - Universitätsmedizin Berlin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital Intervention (Kiso Mind App) + TAU.
The intervention comprises a 12-week digital intervention containing several psychoeducation modules as well as a broad variety of evidence-based psychotherapeutic modules based on CBTp principles. In addition, the digital intervention includes functions to assist with daily challenges, such as medication reminders, mood trackers and emergency contacts.
Behavioral: Digital: Kiso Mind App
See above.
No Intervention: Treatment as Usual
with Schizophrenia or Schizoaffective Disorder in Germany consists of quarterly psychiatric appointments for psychopharmacological treatment. Psychotherapy is typically limited to one appointment a month, in very rare cases multiple appointments a month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of PP receiving threshold dose (Acceptability)
Time Frame: 12 weeks
The proportion of modules completed on average by all participants.
12 weeks
Nr. of pp willing to participate (Feasibility)
Time Frame: 12 weeks
The number of eligible participants, that are willing to participate in Kiso (recruitment)
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Functioning Scale (SFS) (T0, T1)
Time Frame: 12 weeks
Assesses social functioning and role performance, including social engagement, interpersonal behavior, and independent living skills.
12 weeks
System Usability Scale (SUS) (T1, Experimental Group)
Time Frame: 12 weeks
A 10-item questionnaire assessing perceived usability and user-friendliness of a system or digital intervention.
12 weeks
Clinical Global Impression (T0; T1)
Time Frame: 12 weeks

Assesses overall clinical illness severity as judged by the clinician, providing a global rating of the patient's current level of psychopathology.

(Scores: 1 to 7; higher scores = higher illness severity)
12 weeks
Community Assessment of Psychic Experiences (CAPE) (T0, T1)
Time Frame: 12 weeks

Assesses the frequency and distress associated with psychotic-like experiences in the general population, covering positive, negative, and depressive symptom dimensions.

(Scores: 0 to 96; higher scores = higher frequency of psychotic-like experiences AND Scores: 0 to 96; higher scores = higher distress of psychotic like experiences)
12 weeks
Beck Depressions-Inventar (BDI-II) (T0, T1)
Time Frame: 12 weeks

A 21-item self-report questionnaire measuring the severity of depressive symptoms over the past two weeks.

(Scores: 0 to 63; higher scores = higher severity of depressive symptoms)
12 weeks
Brief Symptom Inventory (BSI) (T0, T1)
Time Frame: 12 weeks

A self-report measure assessing general psychological distress across multiple symptom domains (e.g., depression, anxiety, somatization).

(Scores: 0 to 212; higher scores = higher self-reported general psychological distress)
12 weeks
General Self-Efficacy Scale (GSE) (T0, T1)
Time Frame: 12 weeks

Measures perceived self-efficacy, reflecting an individual's belief in their ability to cope with difficult demands and challenges.

(Scores: 4 to 40; higher scores = higher self-efficacy)
12 weeks
EQ-5D Quality of life questionnaire (T0, T1)
Time Frame: 12 weeks

A standardized measure of health-related quality of life, covering mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

(Scores: 5 to 25; higher scores = lower health-related quality of life)
12 weeks
Patient Satisfaction Questionnaire (ZUF-8) (T1, Experimental Group)
Time Frame: 12 weeks

Evaluates patient satisfaction with treatment or services, focusing on perceived quality, usefulness, and overall satisfaction.

(Scores: 4 to 28; higher scores = higher patient satisfaction)
12 weeks
Negative Effects Questionnaire (NEQ) (T1, Experimental Group)
Time Frame: 12 weeks

Assesses adverse and unwanted effects of psychological treatment, including symptom worsening, dependency, or emotional distress.

(Scores: 0 to 116; higher scores = higher severity of unwanted effects)
12 weeks
Medication Adherence Report Scale (MARS-5) (T0, T1)
Time Frame: 12 weeks

A self-report measure assessing medication adherence behavior, including intentional and unintentional non-adherence.

(Scores: 5 to 25; higher scores = higher medication non-adherence)
12 weeks
Patient Global Impression (T0; T1)
Time Frame: 12 weeks
Description: Assesses overall clinical illness severity as judged by the patients, providing a global rating of the patient's perceived current level of psychopathology. (Scores: 1 to 5; higher scores = higher perceived illness severity)
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

Kiso Health GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KISO2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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