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

NCT07755605 | Recruiting

• 2 other identifiers: SMC IRB_2026-04-190HR21C0885
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizoaffecitve Disorder; Schizophrenia

Keywords

Schizophrenia Spectrum Disorder; Social Cognition; Emotion Recognition; Digital Therapeutics; Psychosocial Rehabilitation; AffectUs; Social Cue Perception; Emotion Processing; Mobile Application

Outcome Measures

Primary Outcomes (2)

• Change in Emotion Recognition Performance

  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.

  Baseline and Week 10 (end of treatment)

• Change in Social Cue Perception Performance

  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.

  Baseline and Week 10 (end of treatment)

Secondary Outcomes (14)

• 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

Other Outcomes (2)

• Treatment Adherence

  Week 1 to Week 10

• User Satisfaction With AffectUs

  Week 5 and Week 10

Study Arms (2)

Digital Therapeutic (AffectUs)

EXPERIMENTAL

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.

Behavioral: Digital therapeutic (AffectUs)

Active Control (Psychoeducation)

ACTIVE COMPARATOR

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.

Behavioral: Psychoeducational materials

Interventions

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.

Also known as: Digital therapeutic application for social cognition training

Digital Therapeutic (AffectUs)

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.

Also known as: Schizophrenia management education

Active Control (Psychoeducation)

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Jung-Seok Choi, M.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eunyeong Jang, M.A.

CONTACT

82+10-8685-0502; 21yeong.j@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors administering clinical outcome measures will remain blinded to participants' group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D., Full Professor, Department of Psychiatry, Samsung Medical Center, Sungkyunkwan University School of Medicine

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the digital therapeutic group (AffectUs) or the active control group (psychoeducational materials) in a parallel assignment design.

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)