Digital Therapeutics for Social Cognitive Function in Schizophrenia Spectrum Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-60
SponsorSamsung Medical Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 19 to 60 years.
Meet the diagnostic criteria for schizophrenia or schizoaffective disorder according to DSM-5 and ICD-11.
Have completed at least a middle school education.
Be able to read and write in Korean.
Disqualifiers
Current or past diagnosis of intellectual disability.
Initiation of or current participation in structured psychosocial interventions (e.g., cognitive behavioral therapy or social cognition training) within the past 3 months.
Considered by the investigator to be at significant risk of suicide. 4, Pregnant or having a positive pregnancy test at screening.
Trial design
Design model
Parallel
Treatments tested in this trial
Digital therapeutic (AffectUs)
BehavioralA 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
BehavioralStructured 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Digital Therapeutic (AffectUs)Experimental treatment 1 intervention
Group B: Active Control (Psychoeducation)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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
1
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 52
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 153
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 54
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 15Other outcomes
1
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 102
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 10Sponsors and contacts
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Source ClinicalTrials.gov