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RECRUITING
NCT07755605
NA

Digital Therapeutics for Social Cognitive Function in Schizophrenia Spectrum Disorder

Sponsor: Samsung Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: A Prospective, Randomized Parallel, Single Institution, Researcher-led Clinical Trial on the Effect of Improving Social Cognitive Function by Using Digital Therapy Devices in Patients With Schizophrenia Spectrum Disorder

Key Details

Gender

All

Age Range

19 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-07-15

Completion Date

2027-03

Last Updated

2026-08-21

Healthy Volunteers

No

Interventions

BEHAVIORAL

Digital therapeutic (AffectUs)

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.

BEHAVIORAL

Psychoeducational materials

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.

Locations (1)

Samsung Medical Center

Seoul, South Korea