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Digital Therapeutics for Social Cognitive Function in Schizophrenia Spectrum Disorder

19. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Südkorea
      • Seoul, Südkorea, 06351
        • Rekrutierung
        • Samsung Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Verhalten: 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.
Andere Namen:
  • Digital therapeutic application for social cognition training
Aktiver Komparator: 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.
Verhalten: 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.
Andere Namen:
  • Schizophrenia management education

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Emotion Recognition Performance
Zeitfenster: 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
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Emotion Recognition Performance (Week 5)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Treatment Adherence
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Samsung Medical Center

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. Juli 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2026

Studienabschluss (Geschätzt)

1. März 2027

Studienanmeldedaten

Zuerst eingereicht

4. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. August 2026

Zuerst gepostet (Tatsächlich)

10. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

21. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SMC IRB_2026-04-190
  • HR21C0885 (Andere Zuschuss-/Finanzierungsnummer: Korea Health Industry Development Institute (KHIDI))

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data (IPD) will not be shared.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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