Schizophrenia Spectrum disorders (SSD) are among the most devastating psychiatric disorders. Prominent negative symptoms such as low motivation, anhedonia, asociality, and emotional flattening are experienced by up to 60% of individuals with SSD and are often considered to be the greatest contributors to functional disability. Currently, there are no FDA-approved or cleared medications or therapeutics targeting negative symptoms of schizophrenia. In this phase I proposal, North Shore Therapeutics (NST) is collaborating with the Feinstein Institutes of Medical Research (FIMR; Northwell Health) and the University of Pennsylvania (Penn) to develop a novel augmented reality (AR) therapeutic (NST-SPARK) targeting negative symptoms in individuals with SSD. NST-SPARK is a smartphone application that delivers Recovery-oriented Cognitive Therapy (CT-R) via gamified AR experiences to provide experiential learning that dismantles maladaptive beliefs. Preliminary findings suggest that this approach is feasible, acceptable, and may reduce defeatist beliefs associated with negative symptoms. NST-SPARK v.2.0 is being developed in partnership with a lived experience advisory panel. NST-SPARK v2.0 will deliver a 12-week course of treatment and will be developed over 10 development sprints spanning 9 months. In the second phase, the investigators will introduce NST-SPARK v2.0 to individuals with SSD (n=30) and moderate to severe negative symptoms for 12 weeks in a single-arm open-label study. The primary outcome is the efficacy of NST-SPARK v.2.0 in reducing experiential negative symptoms. Secondary outcomes include efficacy in reducing defeatist beliefs; efficacy in improving functioning; user statistics quantifying adherence to the prescribed sessions; qualitative, semi-structured feedback to guide future product development. This study will set the stage for FDA-informed phase II trials.
Who can participate
Age range
18 Years – 65 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:
* Age 18-65 years
* Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder or unspecified psychotic disorder
* Clinically stable, defined as no acute positive psychotic symptom exacerbation or recent hospitalization or medication changes within the last month.
* Moderate to severe negative symptoms: CAINS MAP subscale \>17 (28).
* Sufficient functioning and capacity to consent and participate in a longitudinal study.
* Actively engaged in outpatient treatment.
* Able and willing to use a smartphone and maintain internet connection during use (through wifi or data plan).
Exclusion Criteria:
* Safety risk (e.g., suicide attempt or homicidal ideation within 12 weeks)
* Issues that prevent subject from using the smartphone app: e.g., hearing, vision, or other relevant physical disability
* IQ \< 70 based on clinical and historical information
* Cognitive impairment limiting engagement in study
* Prominent mood symptoms as defined by active manic, hypomanic or depressive episode.
* Has previously undergone cognitive behavioral therapy for psychosis or recovery-oriented cognitive therapy for negative symptoms.
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.
1This trial is listed as 'not yet recruiting' — do you know when it's expected to open, and would it make sense for me to get on a waitlist or check back at a specific time?
2The trial is described as Phase NA, which seems unusual — can you help me understand what that means for how much is already known about the safety and effectiveness of this approach compared to a more standard Phase 1 study?
3The trial is specifically measuring 'experiential negative symptoms' like reduced motivation or emotional flatness — given my current symptom profile, do you think those are actually a significant part of what I'm dealing with, and would that affect whether this might be worth pursuing?
4Since this is an early-stage feasibility study, the goal seems to be figuring out whether the treatment is acceptable and practical to deliver rather than proving it works — is that the right way to understand it, and how does that change the potential benefit versus risk for me personally?
5Would joining this trial mean pausing or changing any of my current medications for schizophrenia or schizoaffective disorder, and is there a standard treatment option we should consider trying first before looking at an experimental study like this?
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
Experiential negative symptoms
Timeframe: This measure will be collected at baseline and at the 12-week endpoint.
2
Acceptability
Timeframe: This measure will be collected at the 12-week endpoint.
3
Feasibility
Timeframe: This measure will be collected at the 12-week endpoint.