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.
ICD-10: F20 Schizophrenia, F25 Schizoaffective Disorder
Age: 18 - 65 years
Sufficient German Language Proficiency
Ability to Use a Smartphone
Intensive Psychotherapy Protocols (more than one psychotherapy session a month)
CGI-Score < 3; > 6
No smartphone
Neurological Disorders or Brain Damage
Parallel
Digital: Kiso Mind App
BehavioralSee above.
Proportion of PP receiving threshold dose (Acceptability)
The proportion of modules completed on average by all participants.
Nr. of pp willing to participate (Feasibility)
The number of eligible participants, that are willing to participate in Kiso (recruitment)
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)
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)
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)
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)
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Charite University, Berlin, Germany
Lead sponsor
Kiso Health GmbH
Collaborator
