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

North Shore Therapeutics, Inc.

Status: Completed

Conditions: Schizophrenia; Negative Symptoms in Schizophrenia; Schizoaffective Disorder

Treatments: Device: SPARK

Study type: Interventional

Funder types: Industry

Identifiers

NCT06653829

NST-SPARK-1b

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

SSD

Experimental group

Description:

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.

Treatment:

Device: SPARK