NCT07395206

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

January 30, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

January 30, 2026

Last Update Submit

February 28, 2026

Conditions

PsychosisPsychotic DisordersPrimary Psychotic DisordersSchizophrenia Spectrum DisordersSchizophreniaSchizoaffective Disorder

Keywords

PsychosisPsychotic DisordersPrimary Psychotic DisordersSchizophreniaSchizoaffective DisorderSchizophrenia Spectrum DisordersDigital InterventionE-Health

Outcome Measures

Primary Outcomes (2)

  • Proportion of PP receiving threshold dose (Acceptability)

    The proportion of modules completed on average by all participants.

    12 weeks

  • Nr. of pp willing to participate (Feasibility)

    The number of eligible participants, that are willing to participate in Kiso (recruitment)

    12 weeks

Secondary Outcomes (12)

  • Clinical Global Impression (T0; T1)

    12 weeks

  • Patient Global Impression (T0; T1)

    12 weeks

  • Community Assessment of Psychic Experiences (CAPE) (T0, T1)

    12 weeks

  • Beck Depressions-Inventar (BDI-II) (T0, T1)

    12 weeks

  • Brief Symptom Inventory (BSI) (T0, T1)

    12 weeks

  • +7 more secondary outcomes

Study Arms (2)

Digital Intervention (Kiso Mind App) + TAU.

EXPERIMENTAL

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

Treatment as Usual

NO INTERVENTION

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.

Interventions

Digital: Kiso Mind AppBEHAVIORAL

See above.

Digital Intervention (Kiso Mind App) + TAU.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Psychotic DisordersSchizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Central Study Contacts

Pawel Weinstein, M.Sc.

CONTACT

0049 30 450 617 325pawel.weinstein@charite.de

Eric Hahn, PD Dr.

CONTACT

0049 30 450 517 547eric.hahn@charite.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Dr.

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 9, 2026

Study Start

January 30, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 3, 2026

Record last verified: 2026-02

Locations

DE(1)