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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Schizophrenia / Schizoaffective Disorder
• Intervention / Treatment: Device: NST-SPARK

Detailed Description

The investigators will evaluate NST-SPARK v2.0 in a 12-week, single-arm, open-label clinical trial in 30 individuals with schizophrenia spectrum disorders (SSD) who exhibit moderate to severe negative symptoms. Participants will be recruited from stable outpatient populations at Zucker Hillside Hospital (n=20) and the University of Pennsylvania (n=10). The primary objective of the study is to assess the feasibility and acceptability of NST-SPARK, along with generating preliminary evidence of efficacy in reducing experiential negative symptoms. Secondary objectives include evaluating changes in defeatist beliefs, effort expenditure, affect, global functioning, and overall symptom burden, as well as characterizing user engagement and collecting qualitative feedback to inform future product development. The investigators hypothesize that NST-SPARK will demonstrate strong feasibility and acceptability, defined by mean Acceptability of Intervention Measure (AIM) and Feasibility of Intervention Measure (FIM) scores greater than 3.5, and adherence exceeding 75% of prescribed sessions. The investigators further expect to observe moderate improvements in experiential negative symptoms and reductions in defeatist beliefs. Eligible participants will be adults aged 18 and older with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or unspecified psychotic disorder. All participants must be clinically stable, with no recent exacerbation of positive symptoms, hospitalization, or medication changes within the prior month. Participants must exhibit moderate to severe negative symptoms, defined by a CAINS Motivation and Pleasure (MAP) subscale score greater than 17, and must have sufficient cognitive and functional capacity to consent and participate in a longitudinal study. Participants will be excluded if they present a significant safety risk (including recent suicidal or homicidal ideation), have impairments that would prevent use of a smartphone-based intervention (e.g., severe sensory or physical limitations), have an estimated IQ below 70, or demonstrate cognitive or psychiatric conditions that would limit engagement (including active mood episodes such as mania or major depression). Participants will access NST-SPARK either on their personal compatible smartphone or on a study-provided device. A trained research coordinator at each site will support onboarding, conduct assessments, and provide technical assistance. Outcome assessments will be conducted by centralized raters blinded to study conditions for key endpoints. Participants will be instructed to engage with the application at least three times per week over the 12-week treatment period, with the option for more frequent use. Based on prior experience in this population, approximately 20 participants are anticipated to complete the study. Study activities will begin with a screening phase to confirm eligibility, followed by baseline assessments prior to initiating treatment. Participants will then complete interim follow-up assessments at weeks 3, 6, and 9, and a final endpoint assessment at week 12. 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. This will be followed by a three-month period for completion of follow-up assessments and an additional three months for data analysis, manuscript preparation, and planning of a subsequent Phase II study. Input from individuals with lived experience will be incorporated throughout the trial to contextualize findings and inform future study design. Participants will undergo a comprehensive assessment battery spanning diagnostic, symptomatic, behavioral, and functional domains. Diagnostic eligibility will be confirmed during screening using structured clinical interviews focused on mood and psychotic disorders, with additional screening to exclude individuals with significant depressive symptoms. All analyses will be conducted on available data regardless of adherence to the intervention. Given the exploratory nature of this early-stage study, adjustments for multiple comparisons will not be applied. Approximately 20 participants are anticipated to complete the study after accounting for expected attrition. This sample size provides sufficient statistical power to detect moderate treatment effects in within-subject analyses. Key indicators of success include demonstration of strong feasibility and acceptability, meaningful engagement with the intervention, and at least moderate improvement in experiential negative symptoms. In addition, successful completion of this study is expected to yield a trial-ready version of NST-SPARK capable of delivering a full 12-week therapeutic experience, incorporating both cognitive-behavioral and augmented reality components.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: William Cronin, MBA; Phone Number: 214-693-8614; Email: bill@northshore.health
• Study Contact Backup: Name: Moein Foroughi, MD; Phone Number: 507-271-7146; Email: mforoughi@northwell.edu

Study Locations

• United States
  • New York
    • Glen Oaks, New York, United States, 11004
      • Zucker Hillside Hospital
      • Contact: Moein Foroughi, MD; Phone Number: 718-470-8100; Email: mforoughi@northwell.edu
      • Contact: Sunny X Tang, MD; Phone Number: 718-470-8267; Email: stang3@northwell.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Perelman School of Medicine
      • Contact: Daniel Wolf, MD, PhD; Phone Number: 215-573-3538; Email: danwolf@pennmedicine.upenn.edu
      • Contact: Christian Kohler, MD; Phone Number: 215-573-3538; Email: kohler@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: NST-SPARK v.2.0; NST-SPARK v2.0 is a smartphone-based, software-as-a-medical-device digital therapeutic. It comprises 12 weeklong modules, and participants use the app on a personal or study-provided smartphone at least three times weekly over 12 weeks.

Device: NST-SPARK; NST-SPARK v2.0 is a smartphone-based digital therapeutic that delivers recovery-oriented cognitive therapy (CT-R) through gamified augmented reality (AR) experiences to treat negative symptoms of schizophrenia spectrum disorders. Over a 12-week course, participants complete interactive sessions on their smartphone in which the app guides them to (1) identify targeted defeatist beliefs, (2) engage in brief AR activities featuring encouraging prompts and game-like challenges such as sorting objects, (3) reflect on the experience through guided cognitive restructuring, and (4) generalize insights to real-life goal-directed activities. Gamification elements including points, rewards, and progress tracking are integrated throughout to enhance engagement and reinforce effort. NST-SPARK is added to treatment as usual with no changes to participants' existing pharmacotherapy or clinical visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experiential negative symptoms	Experiential negative symptoms include avolition, asociality and anhedonia and will be assessed with the Motivation and Pleasure (MAP) subscale of the Clinical Assessment Interview for Negative Symptoms (CAINS). The MAP scale as an aggregate measure adds together the 9 individual items each ranging from 0 to 4; as an aggregate measure, the CAINS-MAP score ranges from 0 to 36 with 36 representing greater symptom severity.	This measure will be collected at baseline and at the 12-week endpoint.
Acceptability	Acceptability of NST-SPARK v.2.0 will be assessed with the Acceptablilty of Intervention Measure self-report scale (AIM). The AIM consists of 4 items, each scored on a 5-point Likert scale (1 = Completely Disagree to 5 = Completely Agree). The score is reported as the mean of the 4 items, ranging from 1 to 5. Higher scores indicate greater acceptability (better outcome).	This measure will be collected at the 12-week endpoint.
Feasibility	Feasibility of NST-SPARK v.2.0 will be assessed with the Feasibility of Intervention Measure self-report scale (FIM). The FIM consists of 4 items, each scored on a 5-point Likert scale (1 = Completely Disagree to 5 = Completely Agree). The score is reported as the mean of the 4 items, ranging from 1 to 5. Higher scores indicate greater perceived feasibility (better outcome).	This measure will be collected at the 12-week endpoint.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Functioning	Global role and social functioning will be assessed with the Global Functioning (GF) scales from Cornblatt et al. Global role and social functioning will be assessed with the Global Functioning (GF) scales from Cornblatt et al. Each scale is a single-item rating scored from 1 to 10. Higher scores indicate better functioning (better outcome).	This measure will be collected at baseline and at the 12-week endpoint.
Defeatist Beliefs	Defeatist performance beliefs will be assessed with the Beck Defeatist Belief Scale (DBS) self-report. The DBS consists of 15 items, each scored on a 7-point Likert scale (1 = Disagree Totally to 7 = Agree Totally).The score is reported as the total across all 15 items, which ranges from 15 to 105. Higher scores indicate stronger defeatist beliefs (worse outcome). In addition, we will report factor scores for Overvaluing Success (6 items), Overvaluing Failure (7 items), and Overvaluing Social Evaluation (3 items). Factor scores will be reported as a mean item score for that factor from 1 to 7.	This measure will be collected at baseline, during the interim 3-, 6-, and 9-week timepoints, and at the 12-week endpoint.
Positive Self Regard	Positive self regard will be assessed with the Oxford Positive Self (OxPos) self-report scale. There are 24 items rated as a likert scale (0=Do not believe it, 4=believe it totally). The OxPos score will be reported as a total score, which ranges from 0 - 96, with higher score indicating better positive self regard (good outcome). In addition, we may explore the factor scores for Mastery, Strength, Enjoyment, and Character which each range from 0-28.	This measure will be collected at baseline, during the interim 3-, 6-, and 9-week timepoints, and at the 12-week endpoint.
Effort Expenditure	Objective effort expenditure will be measured using a computerized verison of the Progressive Ratio Test (PRT). The primary outcome is the breakpoint, defined as the maximum effort a participant is willing to exert for a given reward. There are no fixed minimum and maximum scale values in the traditional sense; breakpoint values are continuous and depend on task parameters. Higher breakpoints indicate greater motivation (better outcome).	This measure will be collected at baseline, during the interim 3-, 6-, and 9-week timepoints, and at the 12-week endpoint.
Loneliness	Loneliness will be assessed via self-report with the UCLA Loneliness Scale short form (UCLA-LS-3). The UCLA-LS-3 (3-item version) consists of 3 items, each scored on a 3-point scale (1 = Hardly Ever to 3 = Often). Total scores range from 3 to 9. Higher scores indicate greater loneliness (worse outcome).	This measure will be collected at baseline and at the 12-week endpo
Overall Psychosis Symptoms	Overall psychosis symptoms will be assessed with the COMPASS Clinician Rating Form developed for the RAISE-ETP study (COMPASS-10). The COMPASS-10 consists of 10 items. Each item is scored on a scale from 0 to 7, yielding a total score range of 0 - 60. Higher scores indicate more severe psychosis symptoms (worse outcome).	This measure will be collected at baseline and at the 12-week endpoint.
Qualitative Feedback on App Experience	Qualitative feedback will be collected for NST-SPARK through a semi-structured interview. These results will be reported descriptively, using quotes and summaries of the participants' responses.	This measure will be collected at the 12-week endpoint.
Vocal Biomarker Composite Score	Vocal biomarkers composite score for negative symptoms will be extracted from recorded clinical assessments with the centralized rater. Assessments with the CAINS, GF, and COMPASS-10 will be used. The vocal biomarkers will be scored via a single composite z-score benchmarked against external datasets. The composite will be based on external data, compiling which biomarkers are associated with negative symptoms. The definitive way the score will be compiled is still pending ongoing independent studies at this time. There is no minimum or maximum score. Higher score means that the vocal features are more aligned with the expected phenotype for negative symptoms (greater severity).	This measure will be collected at baseline and at the 12-week endpoint.

Collaborators and Investigators

• Sponsor: North Shore Therapeutics, Inc.
• Collaborators: University of Pennsylvania; Northwell Health
• Investigators: Principal Investigator: Moein Foroughi, MD, Feinstein Institute for Medical Research; Principal Investigator: Christian Kohler, MD, Hospital of the University of Pennsylvania, Perelman School of Medicine; Principal Investigator: Dan Wolf, MD, Hospital of the University of Pennsylvania, Perelman School of Medicine

Publications and helpful links

General Publications

• Tang SX, Foroughi M, Brinen AP, Birnbaum ML, Berretta SA, Behbehani LM, Kane JM, Yoon E, Cronin WF. Preliminary Findings From an Augmented Reality (AR) App Delivering Recovery-Oriented Cognitive Therapy for Negative Symptoms in Schizophrenia. Early Interv Psychiatry. 2026 Jan;20(1):e70119. doi: 10.1111/eip.70119.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: schizophrenia; negative symptoms; cognitive behavioral therapy (CBT); avolition; prescription digital therapeutic; recovery-oriented cognitive therapy (CT-R); software as a medical device (SaMD); augmented reality (AR)
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; Psychotic Disorders
• Other Study ID Numbers: NST-SPARK-Phase1; R41MH140642-01A1 (Other Grant/Funding Number: NIMH - Status Pending)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not required for NIMH Phase 1 STTR, but we may shared fully deidentified metadata as a part of the peer-review process for resulting publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No