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Digital Therapeutics for Social Cognitive Function in Schizophrenia Spectrum Disorder

19 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Coréia do Sul
      • Seoul, Coréia do Sul, 06351
        • Recrutamento
        • Samsung Medical Center

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: 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.
Outros nomes:
  • Digital therapeutic application for social cognition training
Comparador Ativo: 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.
Comportamental: 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.
Outros nomes:
  • Schizophrenia management education

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Emotion Recognition Performance
Prazo: 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
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Emotion Recognition Performance (Week 5)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Treatment Adherence
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Samsung Medical Center

Investigadores

  • Investigador principal: Jung-Seok Choi, M.D., Samsung Medical Center

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de julho de 2026

Conclusão Primária (Estimado)

1 de dezembro de 2026

Conclusão do estudo (Estimado)

1 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

4 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de agosto de 2026

Primeira postagem (Real)

10 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • SMC IRB_2026-04-190
  • HR21C0885 (Número de outro subsídio/financiamento: Korea Health Industry Development Institute (KHIDI))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data (IPD) will not be shared.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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