NST-SPARK: Preliminary Study of an Augmented Reality (AR) App Delivering Recovery-Oriented Cognitive Therapy for Negative Symptoms in Schizophrenia (NST-SPARK-1b)

October 21, 2024 updated by: North Shore Therapeutics, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The specific beliefs targeted during each module are queried before engaging in the AR activity to obtain participant buy in. A self-assessment is taken before and then subsequent prompts challenge these beliefs over the course of the activity. After completion of the AR activity the self-assessment is performed again and the results are compared against the pre-activity responses.

The responses received pre- and then post- activity determine the responses SPARK provides to the participant.

Example: Question: How ambitious or motivated do you feel now?

If the post activity response shows a higher level of motivation compared to the pre-activity assessment the participant will receive the following: So you felt more motivated and more energized! And you did more work not less! Like the more you do the better you feel.

The prototype NST-SPARK v.1.5 has 2 modules: 1) SPARK ENERGY and 2) SPARK MOTIVATION, and is an abbreviated experience following the general framework for NST-SPARK.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • North Shore Therapeutics, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SSD
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
A gamified augmented reality activity to recapitulate the beginning activation and engagement phase of each recovery-oriented cognitive therapy (CT-R) session

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of NST-SPARK
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in defeatist beliefs
Time Frame: 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.
Measured by a self-reported scale (Defeatist Beliefs Scale - 5 items scored from 1-7 with 7 being the lowest level of 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
Time Frame: 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.
Customized likert scale and semi-structured questions about participant attitudes toward goals they have identified. Results to be reported quantitatively as degree of agreement with statements regarding intention and confidence in making progress toward the goals (scale from 1-5, 5 being the highest level of agreement). Also reporting yes/no and descriptive responses regarding progress toward goals which will be summarized as a percentage of participants who made progress (or not) and as qualitative responses.
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
Time Frame: 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.
Beck Self Esteem Scale with 18 items rated from 1-10 with 10 representing the lowest level of 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Shore Therapeutics, Inc.

Investigators

  • Principal Investigator: Sunny X Tang, M.D., North Shore Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

August 31, 2024

Study Registration Dates

First Submitted

January 26, 2024

First Submitted That Met QC Criteria

October 21, 2024

First Posted (Actual)

October 22, 2024

Study Record Updates

Last Update Posted (Actual)

October 22, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NST-SPARK-1b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual responses and metadata will be shared for peer review purposes

IPD Sharing Time Frame

metadata will become available after study termination for an indefinite period.

IPD Sharing Access Criteria

Eligible researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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