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Digital Therapeutics for Social Cognitive Function in Schizophrenia Spectrum Disorder

RecruitingNA

Sponsor: Samsung Medical Center

Conditions: Schizophrenia, Schizoaffecitve Disorder

Interventions: Digital therapeutic (AffectUs), Psychoeducational materials

Countries: South Korea

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 overview

Sex: ALL

Age: 19 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

A. Inclusion Criteria

Participants must meet all of the following criteria:

1. Adults aged 19 to 60 years.
2. Meet the diagnostic criteria for schizophrenia or schizoaffective disorder according to DSM-5 and ICD-11.
3. Have completed at least a middle school education.
4. Be able to read and write in Korean.
5. Be able to use a smartphone application independently.
6. Provide written informed consent before participation.
7. Receiving stable antipsychotic treatment (dose variation ≤30%) for at least 3 months before enrollment.

Exclusion Criteria

1. Current or past diagnosis of intellectual disability.
2. Initiation of or current participation in structured psychosocial interventions (e.g., cognitive behavioral therapy or social cognition training) within the past 3 months.
3. Considered by the investigator to be at significant risk of suicide. 4, Pregnant or having a positive pregnancy test at screening.

5\. Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study participation or data interpretation.

Locations (1)

Seoul, South Korea