NST-SPARK: Preliminary Study of an Augmented Reality (AR) App Delivering Recovery-Oriented Cognitive Therapy for Negative Symptoms in Schizophrenia

NCT06653829 | Completed FDA Device

• 1 other identifier: NST-SPARK-1b
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the feasibility and acceptability of a prototype for NST-SPARK (version 1.5). This is an augmented reality (AR) mobile phone application that uses Recovery-oriented Cognitive Therapy (CT-R) to target negative symptoms of schizophrenia. NST-SPARK uses a game AR activity to recapitulate the beginning activation and engagement phase of each CT-R session as per standardized practices for this therapeutic modality.

Conditions

Negative Symptoms in Schizophrenia; Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; Digital Therapeutic; Schizoaffective disorder; Negative Symptoms

Outcome Measures

Primary Outcomes (3)

• Acceptability of NST-SPARK

  Measured by average ratings from the self-reported questionnaire (Acceptability of Intervention Measure, scored from 1-5 with 5 representing the highest level of acceptability).

  This measure will be collected twice: 1) at the first study visit, immediately after using the intervention, and 2) at the 1 week follow-up.

• Feasibility of NST-SPARK

  Measured by average ratings from self-reported questionnaire (Feasibility of Intervention Measure - FIM), scored from 1-5 with 5 representing the highest level of feasibility)

  This measure will be collected twice: 1) at the first study visit, immediately after using the intervention, and 2) at the 1 week follow-up.

• Open-ended feedback about the NST-SPARK user experience

  Qualitative summary of responses to semi-structured open-ended interview to be conducted with participants, eliciting responses to questions like the following: What are your first impressions? What do you like most about the app? What do you like least about the app or what are some areas that need to be improved? Did you experience any negative effects from using the app? For example, dizziness, vertigo, or changes in your symptoms? Do you think you'd be able to use this app from a technical perspective? Does it seem simple enough to operate? If no, which parts seemed confusing or difficult? (Imagine that we added similar but more elaborate experiences for a 12-week long experience, and also provided guides for reaching your goals in the real world.) Would you use this app if your doctor prescribed it for you? What makes you say that?

  This measure will be collected twice: 1) at the first study visit, immediately after using the intervention, and 2) at the 1 week follow-up.

Secondary Outcomes (3)

• Changes in defeatist beliefs

  This measure will be collected three times: 1) at the first study visit, before using the intervention, 2) at the first study visit, immediately after using the intervention, and 3) at the 1 week follow-up.

• Attitude toward goal-oriented activities

  This measure will be collected three times: 1) at the first study visit, before using the intervention, 2) at the first study visit, immediately after using the intervention, and 3) at the 1 week follow-up.

• Changes in Self Esteem

  This measure will be collected three times: 1) at the first study visit, before using the intervention, 2) at the first study visit, immediately after using the intervention, and 3) at the 1 week follow-up.

Study Arms (1)

SSD

EXPERIMENTAL

The study design for participants with SSD is a single-arm open-label intervention study. We will collect descriptive information on feasibility and acceptability. Changes in defeatist beliefs and attitudes toward behavioral changes will be evaluated by comparing self-reported ratings before the app intervention vs. immediately afterward and at the 1-week follow-up. All visits will be conducted over video conference with a trained research coordinator.

Device: SPARK

Interventions

SPARK DEVICE

A gamified augmented reality activity to recapitulate the beginning activation and engagement phase of each recovery-oriented cognitive therapy (CT-R) session

SSD

Eligibility Criteria

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

You may qualify if:

• Meets DSM-5 criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, or unspecified psychotic disorder.
• Presence of negative symptoms - SANS rating of 2 or higher on either Avolition/Apathy or Anhedonia/Asociality subscale.
• Capacity to understand the study procedures and provide informed consent.
• Has dependable access to a device with videoconferencing capability and stable wifi connection which can be accessed by the study iPhone.
• Proficient in English.

You may not qualify if:

• Recent change in level of care: antipsychotic medication changes in the last 4 weeks OR hospitalization or emergency room/crisis visits in the last 12 weeks.
• Acute safety risk - any indication of ongoing risk to themselves or others.
• Substance induced psychotic disorder or primary mood disorder with psychosis.
• Severe cognitive or physical limitations preventing the participant from being able to independently use NST-SPARK.

Sponsors & Collaborators

• North Shore Therapeutics, Inc.: lead

Study Sites (1)

North Shore Therapeutics, Inc.

Rochester, Minnesota, 55902, United States

Location

Related Publications (7)

• Andreasen NC. The Scale for the Assessment of Negative Symptoms (SANS): conceptual and theoretical foundations. Br J Psychiatry Suppl. 1989 Nov;(7):49-58. No abstract available.

  PMID: 2695141 BACKGROUND

• Ascher-Svanum H, Zhu B, Faries DE, Salkever D, Slade EP, Peng X, Conley RR. The cost of relapse and the predictors of relapse in the treatment of schizophrenia. BMC Psychiatry. 2010 Jan 7;10:2. doi: 10.1186/1471-244X-10-2.

  PMID: 20059765 BACKGROUND

• Carbon M, Correll CU. Thinking and acting beyond the positive: the role of the cognitive and negative symptoms in schizophrenia. CNS Spectr. 2014 Dec;19 Suppl 1:38-52; quiz 35-7, 53. doi: 10.1017/S1092852914000601. Epub 2014 Nov 18.

  PMID: 25403863 BACKGROUND

• Correll CU, Galling B, Pawar A, Krivko A, Bonetto C, Ruggeri M, Craig TJ, Nordentoft M, Srihari VH, Guloksuz S, Hui CLM, Chen EYH, Valencia M, Juarez F, Robinson DG, Schooler NR, Brunette MF, Mueser KT, Rosenheck RA, Marcy P, Addington J, Estroff SE, Robinson J, Penn D, Severe JB, Kane JM. Comparison of Early Intervention Services vs Treatment as Usual for Early-Phase Psychosis: A Systematic Review, Meta-analysis, and Meta-regression. JAMA Psychiatry. 2018 Jun 1;75(6):555-565. doi: 10.1001/jamapsychiatry.2018.0623.

  PMID: 29800949 BACKGROUND

• Ford TJ, Buchanan DM, Azeez A, Benrimoh DA, Kaloiani I, Bandeira ID, Hunegnaw S, Lan L, Gholmieh M, Buch V, Williams NR. Taking modern psychiatry into the metaverse: Integrating augmented, virtual, and mixed reality technologies into psychiatric care. Front Digit Health. 2023 Mar 24;5:1146806. doi: 10.3389/fdgth.2023.1146806. eCollection 2023.

  PMID: 37035477 BACKGROUND

• Lundin RM, Yeap Y, Menkes DB. Adverse Effects of Virtual and Augmented Reality Interventions in Psychiatry: Systematic Review. JMIR Ment Health. 2023 May 5;10:e43240. doi: 10.2196/43240.

  PMID: 37145841 BACKGROUND

• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

  PMID: 28851459 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Sunny X Tang, M.D.

  North Shore Therapeutics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A group of participants will be introduced to the device and preliminary feasibility, acceptability, and initial target engagement will be assessed.

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: October 22, 2024
• Study Start: November 6, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: metadata will become available after study termination for an indefinite period.
• Access Criteria: Eligible researchers

Locations

US (1)