Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07395206

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Psychosis Mental Disorders Primary Psychotic Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Schizophrenia Spectrum Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location status: Recruiting

Location contact

Pawel Weinstein, M.Sc.

CONTACT

[email protected]

0049 30 450 617 325

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital: Kiso Mind App

Behavioral

See above.

Primary outcomes

  1. Proportion of PP receiving threshold dose (Acceptability)

    Time frame: 12 weeks

    The proportion of modules completed on average by all participants.

  2. Nr. of pp willing to participate (Feasibility)

    Time frame: 12 weeks

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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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.

  8. 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)

  9. 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)

  10. 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.

  11. 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. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Hahn, PD Dr.

CONTACT

[email protected]

0049 30 450 517 547

Pawel Weinstein, M.Sc.

CONTACT

[email protected]

0049 30 450 617 325

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Kiso Health GmbH

Registry information

Official study title

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

Acronym: KISO

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.