NST-SPARK Open-Label Phase 1 STTR (IGNITE)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNorth Shore Therapeutics, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
NST-SPARK
DeviceNST-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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: NST-SPARK v.2.0Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
This measure will be collected at baseline and at the 12-week endpoint.2
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).
Time frame
This measure will be collected at the 12-week endpoint.3
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).
Time frame
This measure will be collected at the 12-week endpoint.Secondary outcomes
1
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).
Time frame
This measure will be collected at baseline and at the 12-week endpoint.2
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.
Time frame
This measure will be collected at baseline, during the interim 3-, 6-, and 9-week timepoints, and at the 12-week endpoint.3
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.
Time frame
This measure will be collected at baseline, during the interim 3-, 6-, and 9-week timepoints, and at the 12-week endpoint.4
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).
Time frame
This measure will be collected at baseline, during the interim 3-, 6-, and 9-week timepoints, and at the 12-week endpoint.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
North Shore Therapeutics, Inc.
Lead sponsor
Northwell Health
Collaborator
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov
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