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NCT06653829Completed

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

Source: ClinicalTrials.gov · Last updated 22 Oct 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
20 (actual)
First submitted
26 Jan 2024
Start date
6 Nov 2023
Primary completion date
31 Aug 2024
Lead sponsor
North Shore Therapeutics, Inc.
NCT number
NCT06653829

What you commit to

  • Study type: Interventional
  • Participants enrolled: 20
  • From 6 Nov 2023 to the primary completion date, 31 Aug 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Substance induced psychotic disorder or primary mood disorder with psychosis.

Other

  • Acute safety risk - any indication of ongoing risk to themselves or others.
  • Severe cognitive or physical limitations preventing the participant from being able to independently use NST-SPARK.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
North Shore Therapeutics, Inc.
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.