Digital Therapeutics for Social Cognitive Function in Schizophrenia Spectrum Disorder

Samsung Medical Center60 enrolled

Overview

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.

Social cognition refers to the mental processes involved in perceiving, interpreting, and reasoning about others' emotions, intentions, and behaviors. Patients with schizophrenia spectrum disorders consistently exhibit deficits in social cognition, which are associated with impaired social functioning and psychosocial outcomes and remain an important treatment target despite pharmacological management. Although psychosocial interventions targeting social cognition have demonstrated beneficial effects, their implementation is often limited by the need for prolonged, therapist-led, in-person treatment. Recent studies suggest that digital interventions may improve accessibility while producing meaningful improvements in core social cognitive domains, particularly emotion processing and social cue perception. Based on this evidence, AffectUs was developed as a smartphone-based digital therapeutic application that provides brief, repeated, remote training in emotion processing and social cue perception for individuals with schizophrenia spectrum disorders. This exploratory study evaluates the safety and preliminary effectiveness of AffectUs and aims to provide foundational evidence for future confirmatory clinical trials of digital therapeutics for schizophrenia spectrum disorders.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

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 materialsBEHAVIORAL

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

Sex: ALLMin age: 19 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Emotion Recognition Performance

hange from baseline to Week 10 in performance on the Korean Facial Emotion Identification Test (K-FEIT) and Korean Facial Emotion Differentiation Test (K-FEDT). Performance is measured as the proportion of correct responses across all items, ranging from 0 to 1. Higher scores indicate greater accuracy and better emotion recognition performance.

Time frame: Baseline and Week 10 (end of treatment)

Change in Social Cue Perception Performance

Change from baseline to Week 10 in performance on a video-based social cue perception task assessing the ability to interpret social situations and contextual social cues. The total score ranges from 0 to 40, with higher scores indicating better social cue perception performance.

Time frame: Baseline and Week 10 (end of treatment)

Secondary Outcomes

Change in Emotion Recognition Performance (Week 5)

Change from baseline to Week 5 in performance on the Korean Facial Emotion Identification Test (K-FEIT) and Korean Facial Emotion Differentiation Test (K-FEDT). Performance is measured as the proportion of correct responses across all items, ranging from 0 to 1. Higher scores indicate greater accuracy and better emotion recognition performance.

Time frame: Baseline and Week 5

Change in Emotion Recognition Performance (Week 15)

Change from baseline to Week 15 in performance on the Korean Facial Emotion Identification Test (K-FEIT) and Korean Facial Emotion Differentiation Test (K-FEDT). Performance is measured as the proportion of correct responses across all items, ranging from 0 to 1. Higher scores indicate greater accuracy and better emotion recognition performance.

Time frame: Baseline and Week 15

Change in Social Cue Perception Performance (Week 5)

Change from baseline to Week 5 in performance on a clinician-rated, video-based social cue perception task assessing the ability to interpret social situations and contextual social cues. The total score ranges from 0 to 40, with higher scores indicating better social cue perception performance.

Time frame: Baseline and Week 5

Change in Social Cue Perception Performance (Week 15)

Change from baseline to Week 15 in performance on a clinician-rated, video-based social cue perception task assessing the ability to interpret social situations and contextual social cues. The total score ranges from 0 to 40, with higher scores indicating better social cue perception

Time frame: Baseline and Week 15

Change in Social Functioning

Change from baseline in social functioning as measured by the Social and Occupational Functioning Assessment Scale (SOFAS), a clinician-rated scale. The total score ranges from 0 to 100, with higher scores indicating better social functioning.