Digital Therapeutics for Social Cognitive Function in Schizophrenia Spectrum Disorder: A Randomiz… (NCT07755605) | Clinical Trial Compass
RecruitingNot Applicable
Digital Therapeutics for Social Cognitive Function in Schizophrenia Spectrum Disorder: A Randomized Controlled Trial
South Korea60 participantsStarted 2026-07-15
Plain-language 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.
Who can participate
Age range
19 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Emotion Recognition Performance
Timeframe: Baseline and Week 10 (end of treatment)
2
Change in Social Cue Perception Performance
Timeframe: Baseline and Week 10 (end of treatment)
. 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.