Digital Therapeutics for Social Cognitive Function in Schizophrenia Spectrum Disorder

Sponsor
Samsung Medical Center
Study ID
NCT07755605
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 60 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Aug 10, 2026
Start date
Jul 15, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: 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.

Primary Outcome Measure

Change in Emotion Recognition Performance [ Time Frame: Baseline and Week 10 (end of treatment) ]

Central Contacts

Find similar trials

Nationwide
Schizophrenia trialsPsychiatry trialsMental health trialsBehavioral health trials

Related Studies