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Completed

NCT Number: NCT06653829

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

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.

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Key information

Conditions

Negative Symptoms in Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Shore Therapeutics, Inc.

Rochester, Minnesota, 55902, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SPARK

Device

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

Primary outcomes

  1. 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).

  2. 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)

  3. 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?

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

North Shore Therapeutics, Inc.

Industry

Registry information

Acronym: NST-SPARK-1b

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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