Schizoaffecitve Disorder, Schizophrenia
Conditions
Keywords
Schizophrenia Spectrum Disorder, Social Cognition, Emotion Recognition, Digital Therapeutics, Psychosocial Rehabilitation, AffectUs, Social Cue Perception, Emotion Processing, Mobile Application
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALDigital 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.
BEHAVIORALPsychoeducational 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.
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors administering clinical outcome measures will remain blinded to participants' group assignments.
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to either the digital therapeutic group (AffectUs) or the active control group (psychoeducational materials) in a parallel assignment design.
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Emotion Recognition Performance | Baseline and Week 10 (end of treatment) | 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. |
| Change in Social Cue Perception Performance | Baseline and Week 10 (end of treatment) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Social Cue Perception Performance (Week 15) | Baseline and 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 |
| Change in Social Functioning | Baseline, Week 10, and Week 15 | 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. |
| Change in Schizophrenia Symptom Severity | Baseline, Week 10, and Week 15 | 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. |
| Change in Emotional Intelligence | Baseline, Week 10, and Week 15 | 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. |
| Change in Quality of Life | Baseline, Week 10, and Week 15 | 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. |
| Change in Depressive Symptoms | Baseline, Week 10, and Week 15 | 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. |
| Change in Emotion Recognition Performance (Week 15) | Baseline and 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. |
| Change in Perceived Stress | Baseline, Week 10, and Week 15 | 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. |
| Change in Resilience | Baseline, Week 10, and Week 15 | 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. |
| Change in Self-Esteem | Baseline, Week 10, and Week 15 | 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. |
| Change in Insight | Baseline, Week 10, and Week 15 | 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. |
| Change in Disability and Functioning | Baseline, Week 10, and Week 15 | 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. |
| Change in Emotion Recognition Performance (Week 5) | Baseline and 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. |
| Change in Anxiety Symptoms | Baseline, Week 10, and Week 15 | 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. |
| Change in Social Cue Perception Performance (Week 5) | Baseline and 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. |
Countries
South Korea
Contacts
CONTACTEunyeong Jang, M.A.
PRINCIPAL_INVESTIGATORJung-Seok Choi, M.D.
Samsung Medical Center
Outcome results
None listed