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

Completed · Not applicable

Conditions studied: Negative Symptoms in Schizophrenia, Schizophrenia, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT06653829

Run by

North Shore Therapeutics, Inc.

People needed

20

Starts

2023-11-06

Expected to finish

2024-08-31

Last updated by the study team

2024-10-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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