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Digital Therapeutics for Social Cognitive Function in Schizophrenia Spectrum Disorder

Sponsor: Samsung Medical Center • ClinicalTrials.gov ID: NCT07755605

Registry updated: 2026-08-21

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Description

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.

Interventions

Digital therapeutic (AffectUs) (Behavioral)
A smartphone-based digital therapeutic application (AffectUs) that provides structured social cognition training focused on emotion processing and social cue perception. Participants use the application five times per week for approximately 10-15 minutes per session over a 10-week period (total 50 sessions). The program is self-guided and delivered through a smartphone application.
Psychoeducational materials (Behavioral)
Structured psychoeducational materials providing information about schizophrenia, medication adherence, stress management, and daily self-management. Participants receive one psychoeducational module per week over a 10-week period. The content is informational and does not include social cognition training components.

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.

Conditions

Schizophrenia Schizoaffecitve Disorder

Locations

Samsung Medical Center — Seoul, South Korea

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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