Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital: Kiso Mind App.
- Who it may be relevant to
- Registry conditions: Psychosis, Psychotic Disorders, Primary Psychotic Disorders, Schizophrenia Spectrum Disorders. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders: A Randomized Controlled Pilot Trial
Overview
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.
Interventions
- Behavioral Digital: Kiso Mind App
See above.
Primary outcome measures
- Proportion of PP receiving threshold dose (Acceptability) [Time frame: 12 weeks]
- Nr. of pp willing to participate (Feasibility) [Time frame: 12 weeks]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Charité - Universitätsmedizin Berlin — Berlin
Identifiers
NCT: NCT07395206 · KISO2026