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NCT Number: NCT07755605

Digital Therapeutics for Social Cognitive Function in Schizophrenia Spectrum Disorder: A Randomized Controlled 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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizoaffecitve Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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-11.
  • 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.

Exclusion criteria

  • 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.
  • Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study participation or data interpretation.

Treatment and study plan

Digital therapeutic (AffectUs)

Behavioral

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.

Other names: Digital therapeutic application for social cognition training

Psychoeducational Materials

Behavioral

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.

Other names: Schizophrenia management education

Primary outcomes

  1. Change in Emotion Recognition Performance

    Time frame: Baseline and Week 10 (end of treatment)

    Change from baseline in performance on the Korean Facial Emotion Identification Test (K-FEIT) and Korean Facial Emotion Differentiation Test (K-FEDT). Higher scores indicate better emotion recognition performance.

  2. Change in Social Cue Perception Performance

    Time frame: Baseline and Week 10 (end of treatment)

    Change from baseline in performance on a video-based social cue perception task assessing the ability to interpret social situations and contexual social cues. Higher scores indicate better social cue perception performance.

Secondary outcomes

  1. Change in Emotion Recognition Performance (Week 5)

    Time frame: Baseline and Week 5

    Change from baseline in performance on the Korean Facial Emotion Identification Test (K-FEIT) and Korean Facial Emotion Differentiation Test (K-FEDT) at Week 5. Higher scores indicate better emotion recognition performance.

  2. Change in Emotion Recognition Performance (Week 15)

    Time frame: Baseline and Week 15

    Change from baseline in performance on the Korean Facial Emotion Identification Test (K-FEIT) and Korean Facial Emotion Differentiation Test (K-FEDT) at Week 15 follow-up. Higher scores indicate better emotion recognition performance.

  3. Change in Social Cue Perception Performance (Week 5)

    Time frame: Baseline and Week 5

    Change from baseline in performance on a clinician-rated, video-based social cue perception task at Week 5. Higher scores indicate better social cue perception performance.

  4. Change in Social Cue Perception Performance (Week 15)

    Time frame: Baseline and Week 15

    Change from baseline in performance on a clinician-rated, video-based social cue perception task at Week 15 follow-up. Higher scores indicate better social cue perception performance.

  5. Change in Social Functioning

    Time frame: Baseline, Week 10, and Week 15

    Change from baseline in social functioning as measured by the Social and Occupational Functioning Assessment Scale (SOFAS). Higher scores indicate better social functioning.

  6. Change in Schizophrenia Symptom Severity

    Time frame: 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). Higher scores indicate greater symptom severity.

  7. Change in Emotional Intelligence

    Time frame: Baseline, Week 10, and Week 15

    Change from baseline in emotional intelligence as measured by the Emotional Intelligence Diagnostic Test. Higher scores indicate better emotional intelligence.

  8. Change in Quality of Life

    Time frame: Baseline, Week 10, and Week 15

    Change from baseline in quality of life as measured by the WHO Quality of Life-BREF (WHOQOL-BREF). Higher scores indicate better quality of life.

  9. Change in Depressive Symptoms

    Time frame: Baseline, Week 10, and Week 15

    Change from baseline in depressive symptom severity as measured by the Patient Health Questionnaire-9 (PHQ-9). Higher scores indicate greater depressive symptom severity.

  10. Change in Anxiety Symptoms

    Time frame: Baseline, Week 10, and Week 15

    Change from baseline in anxiety symptom severity as measured by the Generalized Anxiety Disorder-7 (GAD-7). Higher scores indicate greater anxiety symptom severity.

  11. Change in Perceived Stress

    Time frame: Baseline, Week 10, and Week 15

    Change from baseline in perceived stress as measured by the Perceived Stress Scale-10 (PSS-10). Higher scores indicate greater perceived stress.

  12. Change in Resilience

    Time frame: Baseline, Week 10, and Week 15

    Change from baseline in resilience as measured by the Brief Resilience Scale (BRS). Higher scores indicate greater resilience.

  13. Change in Self-Esteem

    Time frame: Baseline, Week 10, and Week 15

    Change from baseline in self-esteem as measured by the Rosenberg Self-Esteem Scale (R-SES). Higher scores indicate higher self-esteem.

  14. Change in Insight

    Time frame: Baseline, Week 10, and Week 15

    Change from baseline in insight as measured by the Birchwood Insight Scale (BIS). Higher scores indicate better insight.

Other outcomes

  1. Treatment Adherence

    Time frame: Week 1 to Week 10

    Proportion of participants completing the 10-week intervention, assessed by AffectUs training progress and the number of app launches.

  2. User Satisfaction With AffectUs

    Time frame: Week 5 and Week 10

    User satisfaction with the AffectUs program assessed using a single-item satisfaction question in the digital therapeutic group. Higher scores indicate greater satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Eunyeong Jang, M.A.

CONTACT

[email protected]

82+10-8685-0502

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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