Digital Therapeutics for Social Cognition in Schizophrenia Spectrum Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares AffectUs plus treatment as usual to psychoeducational materials plus treatment as usual in adults with schizophrenia spectrum disorders. Participants are assessed at baseline, week 5, week 10, and week 15 to measure social cognition, clinical outcomes, and safety. The study aims to gather safety data and preliminary signals of effectiveness to inform future larger trials. AffectUs delivers brief, repeated training on emotion processing and social cue perception via a mobile app. The trial is conducted at Samsung Medical Center in Seoul, with inclusion criteria focused on stable antipsychotic treatment and smartphone use, and exclusions including intellectual disability and recent psychosocial intervention.

Why it matters

Who can join: the full rules

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.

Where it's running

• Samsung Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Jung-Seok Choi, M.D. — Samsung Medical Center
• Study coordinator: Eunyeong Jang, M.A.
• Email: 21yeong.j@gmail.com
• Phone: 82+10-8685-0502

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.