NCT07755605Recruiting
Digital Therapeutics for Social Cognitive Function in Schizophrenia Spectrum Disorder
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
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 4 Aug 2026
- Start date
- 15 Jul 2026
- Primary completion date
- Dec 2026
- Lead sponsor
- Samsung Medical Center
- Diseases
- Schizophrenia
- NCT number
- NCT07755605
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 15 Jul 2026 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Initiation of or current participation in structured psychosocial interventions (e.g., cognitive behavioral therapy or social cognition training) within the past 3 months.
Other illness
- 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.
Other
- Current or past diagnosis of intellectual disability.
Criteria the registry did not label
- 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.
Age in the registry: 19 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.