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

NCT07593456 | Not Yet Recruiting FDA Device

• 2 other identifiers: NST-SPARK-Phase1R41MH140642-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Schizophrenia / Schizoaffective Disorder

Keywords

schizophrenia; recovery-oriented cognitive therapy (CT-R); cognitive behavioral therapy (CBT); prescription digital therapeutic; software as a medical device (SaMD); augmented reality (AR); negative symptoms; avolition

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Global Functioning

  This measure will be collected at baseline and at the 12-week endpoint.

• Defeatist Beliefs

  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

  This measure will be collected at baseline, during the interim 3-, 6-, and 9-week timepoints, and at the 12-week endpoint.

• Effort Expenditure

  This measure will be collected at baseline, during the interim 3-, 6-, and 9-week timepoints, and at the 12-week endpoint.

• Loneliness

  This measure will be collected at baseline and at the 12-week endpo

Study Arms (1)

NST-SPARK v.2.0

EXPERIMENTAL

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

Interventions

NST-SPARK DEVICE

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.

NST-SPARK v.2.0

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• North Shore Therapeutics, Inc.: lead
• Northwell Health: collaborator
• University of Pennsylvania: collaborator

Study Sites (2)

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 41496485 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Cronin, MBA

CONTACT

214-693-8614; bill@northshore.health

Moein Foroughi, MD

CONTACT

507-271-7146; mforoughi@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The primary outcomes assessor (a centralized rater) will be masked to the level of adherence of the participant - i.e., whether they are completing many sessions or are not actively using the therapeutic.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label, single-arm, minimal risk clinical trial for a digital therapeutic app that provides recovery-oriented cognitive therapy targeting negative symptoms of schizophrenia spectrum disorders.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

US (2)