Digital Therapeutics for Social Cognitive Function in Schizophrenia Spectrum Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-60
SponsorSamsung Medical Center
About this trial
The purpose of this study is to evaluate the safety and preliminary effectiveness of a smartphone-based digital therapeutic application (AffectUs) for improving social cognition, particularly emotion processing and social cue perception, in individuals with schizophrenia spectrum disorders.
In this randomized controlled trial, participants will be assigned either to use AffectUs for 10 weeks in addition to treatment as usual or to receive psychoeducational materials and treatment as usual. Participants will complete assessments at baseline, week 5, week 10, and week 15 to evaluate social cognition, clinical outcomes, and safety.
Eligibility criteria
Qualifiers
Adults aged 19 to 60 years.
Meet the diagnostic criteria for schizophrenia or schizoaffective disorder according to DSM-5 and ICD-11.
Have completed at least a middle school education.
Be able to read and write in Korean.
Disqualifiers
Current or past diagnosis of intellectual disability.
Initiation of or current participation in structured psychosocial interventions (e.g., cognitive behavioral therapy or social cognition training) within the past 3 months.
Considered by the investigator to be at significant risk of suicide. 4, Pregnant or having a positive pregnancy test at screening.
Trial design
Treatments tested in this trial
- Digital therapeutic (AffectUs)
- Psychoeducational materials
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov