PsychosisKISONCT07395206
Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders
A study testing Digital: Kiso Mind App in people with Psychosis and Psychotic Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychosis, Psychotic Disorders, Primary Psychotic Disorders
- What is being tested?
- Digital: Kiso Mind App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 30 Jan 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICD-10: F20 Schizophrenia, F25 Schizoaffective Disorder
- Age: 18 - 65 years
- Sufficient German Language Proficiency
- Ability to Use a Smartphone
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
Pawel Weinstein, M.Sc., 0049 30 450 617 325, pawel.weinstein@charite.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychosis, Psychotic Disorders, Primary Psychotic Disorders, Schizophrenia Spectrum Disorders, Schizophrenia, Schizoaffective Disorder
- Being tested
- Digital: Kiso Mind App
- Keywords
- Psychosis, Psychotic Disorders, Primary Psychotic Disorders, Schizophrenia, Schizoaffective Disorder, Schizophrenia Spectrum Disorders, Digital Intervention, E-Health
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital: Kiso Mind AppBehavioural
See above.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of PP receiving threshold dose (Acceptability)
The proportion of modules completed on average by all participants.
Measured: 12 weeks
Nr. of pp willing to participate (Feasibility)
The number of eligible participants, that are willing to participate in Kiso (recruitment)
Measured: 12 weeks
Secondary outcomes (12)
Clinical Global Impression (T0; T1)
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)
Measured: 12 weeks
Patient Global Impression (T0; T1)
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)
Measured: 12 weeks
Community Assessment of Psychic Experiences (CAPE) (T0, T1)
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)
Measured: 12 weeks
Beck Depressions-Inventar (BDI-II) (T0, T1)
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)
Measured: 12 weeks
Brief Symptom Inventory (BSI) (T0, T1)
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)
Measured: 12 weeks
General Self-Efficacy Scale (GSE) (T0, T1)
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)
Measured: 12 weeks
Social Functioning Scale (SFS) (T0, T1)
Assesses social functioning and role performance, including social engagement, interpersonal behavior, and independent living skills.
Measured: 12 weeks
EQ-5D Quality of life questionnaire (T0, T1)
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)
Measured: 12 weeks
Patient Satisfaction Questionnaire (ZUF-8) (T1, Experimental Group)
Evaluates patient satisfaction with treatment or services, focusing on perceived quality, usefulness, and overall satisfaction.
(Scores: 4 to 28; higher scores = higher patient satisfaction)
Measured: 12 weeks
System Usability Scale (SUS) (T1, Experimental Group)
A 10-item questionnaire assessing perceived usability and user-friendliness of a system or digital intervention.
Measured: 12 weeks
Negative Effects Questionnaire (NEQ) (T1, Experimental Group)
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)
Measured: 12 weeks
Medication Adherence Report Scale (MARS-5) (T0, T1)
A self-report measure assessing medication adherence behavior, including intentional and unintentional non-adherence.
(Scores: 5 to 25; higher scores = higher medication non-adherence)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start30 Jan 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Kiso Health GmbH
- Responsible party
- Principal investigator, Kerem Böge, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395206
- Sponsor's protocol ID
- KISO2026
- Acronym
- KISO
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders: A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07395206
- Acronym / sponsor ID
- KISO / KISO2026
- Conditions
- Psychosis, Psychotic Disorders, Primary Psychotic Disorders, Schizophrenia Spectrum Disorders, Schizophrenia, Schizoaffective Disorder
- Keywords
- Psychosis, Psychotic Disorders, Primary Psychotic Disorders, Schizophrenia, Schizoaffective Disorder, Schizophrenia Spectrum Disorders, Digital Intervention, E-Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Kiso Health GmbH
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Intervention (Kiso Mind App) + TAU. | Experimental | Behavioral: Digital: Kiso Mind AppThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ICD-10: F20 Schizophrenia, F25 Schizoaffective Disorder
- Age: 18 - 65 years
- Sufficient German Language Proficiency
- Ability to Use a Smartphone
Key exclusion criteria (7 listed)
- Intensive Psychotherapy Protocols (more than one psychotherapy session a month)
- CGI-Score < 3; > 6
- No smartphone
- Neurological Disorders or Brain Damage
- Acute Suicidality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital: Kiso Mind AppSee above. | Behavioural | Digital Intervention (Kiso Mind App) + TAU. |
Primary outcome
Proportion of PP receiving threshold dose (Acceptability)
Time frame: 12 weeks
The proportion of modules completed on average by all participants.
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 secondary outcomes
Clinical Global Impression (T0; T1)
Time frame: 12 weeks
Patient Global Impression (T0; T1)
Time frame: 12 weeks
Community Assessment of Psychic Experiences (CAPE) (T0, T1)
Time frame: 12 weeks
Beck Depressions-Inventar (BDI-II) (T0, T1)
Time frame: 12 weeks
Brief Symptom Inventory (BSI) (T0, T1)
Time frame: 12 weeks
General Self-Efficacy Scale (GSE) (T0, T1)
Time frame: 12 weeks
Social Functioning Scale (SFS) (T0, T1)
Time frame: 12 weeks
EQ-5D Quality of life questionnaire (T0, T1)
Time frame: 12 weeks
Patient Satisfaction Questionnaire (ZUF-8) (T1, Experimental Group)
Time frame: 12 weeks
System Usability Scale (SUS) (T1, Experimental Group)
Time frame: 12 weeks
Negative Effects Questionnaire (NEQ) (T1, Experimental Group)
Time frame: 12 weeks
Medication Adherence Report Scale (MARS-5) (T0, T1)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital: Kiso Mind App in people with Psychosis and Psychotic Disorders, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pawel Weinstein, M.Sc. (0049 30 450 617 325, pawel.weinstein@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of PP receiving threshold dose (Acceptability) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.