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Digital Therapeutics for Social Cognitive Function in Schizophrenia Spectrum Disorder

2026년 8월 19일 업데이트: Jung-Seok Choi, Samsung Medical Center

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

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 대한민국
      • Seoul, 대한민국, 06351
        • 모병
        • Samsung Medical Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
행동: Digital 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.
다른 이름들:
  • Digital therapeutic application for social cognition training
활성 비교기: 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.
행동: Psychoeducational 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.
다른 이름들:
  • Schizophrenia management education

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Emotion Recognition Performance
기간: 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.
Baseline and Week 10 (end of treatment)
Change in Social Cue Perception Performance
기간: 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.
Baseline and Week 10 (end of treatment)

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Emotion Recognition Performance (Week 5)
기간: 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.
Baseline and Week 5
Change in Emotion Recognition Performance (Week 15)
기간: 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.
Baseline and Week 15
Change in Social Cue Perception Performance (Week 5)
기간: 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.
Baseline and Week 5
Change in Social Cue Perception Performance (Week 15)
기간: 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
Baseline and Week 15
Change in Social Functioning
기간: 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.
Baseline, Week 10, and Week 15
Change in Schizophrenia Symptom Severity
기간: 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.
Baseline, Week 10, and Week 15
Change in Emotional Intelligence
기간: 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.
Baseline, Week 10, and Week 15
Change in Quality of Life
기간: 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.
Baseline, Week 10, and Week 15
Change in Depressive Symptoms
기간: 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.
Baseline, Week 10, and Week 15
Change in Anxiety Symptoms
기간: 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.
Baseline, Week 10, and Week 15
Change in Perceived Stress
기간: 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.
Baseline, Week 10, and Week 15
Change in Resilience
기간: 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.
Baseline, Week 10, and Week 15
Change in Self-Esteem
기간: 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.
Baseline, Week 10, and Week 15
Change in Insight
기간: 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.
Baseline, Week 10, and Week 15
Change in Disability and Functioning
기간: 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.
Baseline, Week 10, and Week 15

기타 결과 측정

결과 측정
측정값 설명
기간
Treatment Adherence
기간: Week 1 to Week 10
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.
Week 1 to Week 10
User Satisfaction With AffectUs
기간: Week 5 and Week 10
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.
Week 5 and Week 10

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Samsung Medical Center

수사관

  • 수석 연구원: Jung-Seok Choi, M.D., Samsung Medical Center

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 7월 15일

기본 완료 (추정된)

2026년 12월 1일

연구 완료 (추정된)

2027년 3월 1일

연구 등록 날짜

최초 제출

2026년 8월 4일

QC 기준을 충족하는 최초 제출

2026년 8월 4일

처음 게시됨 (실제)

2026년 8월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 19일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • SMC IRB_2026-04-190
  • HR21C0885 (기타 보조금/기금 번호: Korea Health Industry Development Institute (KHIDI))

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data (IPD) will not be shared.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다