An interventional study of Digital therapeutic (AffectUs) and Psychoeducational materials in Schizophrenia and Schizoaffecitve Disorder, sponsored by Samsung Medical Center. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment
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.
A. Inclusion Criteria
Participants must meet all of the following criteria:
Exclusion Criteria
5. Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study participation or data interpretation.
Participants use the AffectUs digital therapeutic application, which provides structured social cognition training focused on emotion processing and social cue perception, five times per week for approximately 10-15 minutes per session over a 10-week period (total 50 sessions), in addition to standard psychiatric care.
Behavioral: Digital therapeutic (AffectUs)
Participants receive standard psychiatric care in addition to weekly psychoeducational materials covering schizophrenia, medication adherence, stress management, sleep, self-care, and crisis coping strategies over a 10-week period.
Behavioral: Psychoeducational materials
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.
Also known as: Digital therapeutic application for social cognition training
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.
Also known as: Schizophrenia management education
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)
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.
Time frame: Baseline, Week 10, and Week 15
Change in Schizophrenia Symptom Severity
Change from baseline in total and subscale scores on the Korean version of the Positive and Negative Syndrome Scale (K-PANSS). The Positive and Negative subscale scores each range from 7 to 49, the General Psychopathology subscale score ranges from 16 to 112, and the total score ranges from 30 to 210. Higher scores indicate greater schizophrenia symptom severity.
Time frame: Baseline, Week 10, and Week 15
Change in Emotional Intelligence
Change from baseline in emotional intelligence as measured by the Emotional Intelligence Diagnostic Test. The total score ranges from 50 to 250, with higher scores indicating better emotional intelligence.
Time frame: Baseline, Week 10, and Week 15
Change in Quality of Life
Change from baseline in quality of life as measured by the World Health Organization Quality of Life-BREF (WHOQOL-BREF). The WHOQOL-BREF includes four domain scores: Physical Health, Psychological, Social Relationships, and Environment. Each domain score is transformed to a scale ranging from 0 to 100, with higher scores indicating better quality of life. Two additional single items assess overall quality of life and satisfaction with general health, each ranging from 1 to 5, with higher scores indicating better overall quality of life and greater satisfaction with health, respectively.
Time frame: Baseline, Week 10, and Week 15
Change in Depressive Symptoms
Change from baseline in depressive symptom severity as measured by the Patient Health Questionnaire-9 (PHQ-9). The total score ranges from 0 to 27, with higher scores indicating greater depressive symptom severity.
Time frame: Baseline, Week 10, and Week 15
Change in Anxiety Symptoms
Change from baseline in anxiety symptom severity as measured by the Generalized Anxiety Disorder-7 (GAD-7). The total score ranges from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Time frame: Baseline, Week 10, and Week 15
Change in Perceived Stress
Change from baseline in perceived stress as measured by the Perceived Stress Scale-10 (PSS-10). The total score ranges from 0 to 40, with higher scores indicating greater perceived stress.
Time frame: Baseline, Week 10, and Week 15
Change in Resilience
It's not strictly necessary just to satisfy the reviewer's request, but it prevents ambiguity because someone seeing a 6-item scale might otherwise expect the possible score to be 6-30. Stating that the mean score ranges from 1 to 5 makes it immediately clear why the reported range is 1-5.
Time frame: Baseline, Week 10, and Week 15
Change in Self-Esteem
Change from baseline in self-esteem as measured by the Rosenberg Self-Esteem Scale (R-SES). The total score ranges from 10 to 40, with higher scores indicating higher self-esteem.
Time frame: Baseline, Week 10, and Week 15
Change in Insight
Change from baseline in insight as measured by the Birchwood Insight Scale (BIS). The total score ranges from 0 to 16, with higher scores indicating better insight.
Time frame: Baseline, Week 10, and Week 15
Change in Disability and Functioning
Change from baseline in disability and functioning as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0), 36-item version. Using the complex scoring method, the summary score ranges from 0 to 100, with higher scores indicating greater disability and functional impairment.
Time frame: Baseline, Week 10, and Week 15
Treatment Adherence
Treatment adherence will be assessed based on AffectUs training completion during the 10-week intervention. The training completion rate will be calculated as the percentage of prescribed training sessions completed out of 50 total sessions, ranging from 0% to 100%, with higher percentages indicating greater treatment adherence.
Time frame: Week 1 to Week 10
User Satisfaction With AffectUs
User satisfaction with the AffectUs program assessed using a single-item satisfaction question in the digital therapeutic group. The score ranges from 1 to 7, with higher scores indicating greater satisfaction.
Time frame: Week 5 and Week 10
Plan to share: No — Individual participant data (IPD) will not be shared.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Samsung Medical Center