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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Emotion Recognition Performance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors administering clinical outcome measures will remain blinded to participants' group assignments.
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. Inclusion Criteria
- •Participants must meet all of the following criteria:
- •Adults aged 19 to 60 years.
- •Meet the diagnostic criteria for schizophrenia or schizoaffective disorder according to DSM-5 and ICD-
- •Have completed at least a middle school education.
- •Be able to read and write in Korean.
- •Be able to use a smartphone application independently.
- •Provide written informed consent before participation.
- •Receiving stable antipsychotic treatment (dose variation ≤30%) for at least 3 months before enrollment.
排除标准
- •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.
- •5. Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study participation or data interpretation.
研究组 & 干预措施
Digital Therapeutic (AffectUs)
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.
干预措施: Digital therapeutic (AffectUs) (Behavioral)
Active Control (Psychoeducation)
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.
干预措施: Psychoeducational materials (Behavioral)
结局指标
主要结局
Change in Emotion Recognition Performance
时间窗: 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
时间窗: 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.
次要结局
- Change in Emotion Recognition Performance (Week 5)(Baseline and Week 5)
- Change in Emotion Recognition Performance (Week 15)(Baseline and Week 15)
- Change in Social Cue Perception Performance (Week 5)(Baseline and Week 5)
- Change in Social Cue Perception Performance (Week 15)(Baseline and Week 15)
- Change in Social Functioning(Baseline, Week 10, and Week 15)
- Change in Schizophrenia Symptom Severity(Baseline, Week 10, and Week 15)
- Change in Emotional Intelligence(Baseline, Week 10, and Week 15)
- Change in Quality of Life(Baseline, Week 10, and Week 15)
- Change in Depressive Symptoms(Baseline, Week 10, and Week 15)
- Change in Anxiety Symptoms(Baseline, Week 10, and Week 15)
- Change in Perceived Stress(Baseline, Week 10, and Week 15)
- Change in Resilience(Baseline, Week 10, and Week 15)
- Change in Self-Esteem(Baseline, Week 10, and Week 15)
- Change in Insight(Baseline, Week 10, and Week 15)
- Change in Disability and Functioning(Baseline, Week 10, and Week 15)
研究者
Jung-Seok Choi
M.D., Ph.D., Full Professor, Department of Psychiatry, Samsung Medical Center, Sungkyunkwan University School of Medicine
Samsung Medical Center