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NST-SPARK Open-Label Phase 1 STTR (IGNITE)

Investigating a Gamified NegatIve-symptom Therapeutic Based on Evidence-based Cognitive Therapy (IGNITE)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 weeks, 10 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Recruitment will begin after finalization of the NST-SPARK v2.0 platform, with enrollment occurring over approximately 10 months at a rate of 3-4 participants per month."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests NST-SPARK, a smartphone app that uses games and adds digital images to the real world to deliver talk therapy. It is for adults with schizophrenia or related disorders who have moderate to severe problems with motivation, enjoyment, or social interest. Participants will use the app for 12 weeks to see if it helps these symptoms.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18 to 65 years old.
  • Have schizophrenia, schizoaffective disorder, schizophreniform disorder, or an unspecified psychotic disorder.
  • Have had no sudden worsening of psychotic symptoms, hospital stays, or medicine changes in the past month.
  • Have moderate to severe problems with motivation, enjoyment, or social interest, with a score above 17 on the study’s symptom scale.
  • Can give consent and take part in the study over time.
  • Are getting ongoing mental health care outside a hospital.
  • Can and will use a smartphone with internet access through Wi-Fi or a data plan.

Who can't join

  • Have a safety risk, such as a suicide attempt or thoughts of killing someone within the past 12 weeks.
  • Have hearing, vision, or other physical problems that prevent use of the app.
  • Have an IQ below 70, based on medical and past information.
  • Have thinking or memory problems that limit study participation.
  • Are currently having an episode of depression, mania, or hypomania (unusually high energy or mood).
  • Have had cognitive behavioral therapy for psychosis or recovery-oriented cognitive therapy for low motivation and related symptoms.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (2)

NY

PA