Clinical trial NCT06653829: NST-SPARK: Preliminary Study of an Augmented Reality (AR) App Delivering Recovery-Oriented Cognitive Therapy for Negative Symptoms in Schizophrenia
Official title: NST-SPARK: Preliminary Study of an Augmented Reality (AR) App Delivering Recovery-Oriented Cognitive Therapy for Negative Symptoms in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Negative Symptoms in Schizophrenia
Schizophrenia
Schizoaffective Disorder
Keywords: Schizophrenia
Digital Therapeutic
Schizoaffective disorder
Negative Symptoms
Lead sponsor: North Shore Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A group of participants will be introduced to the device and preliminary feasibility, acceptability, and initial target engagement will be assessed.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability of NST-SPARK
timeFrame: 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.
measure: Feasibility of NST-SPARK
timeFrame: 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.
measure: Open-ended feedback about the NST-SPARK user experience
timeFrame: 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 outcomes:
measure: Changes in defeatist beliefs
timeFrame: 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.
measure: Attitude toward goal-oriented activities
timeFrame: 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.
measure: Changes in Self Esteem
timeFrame: 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.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: North Shore Therapeutics, Inc.
state: Minnesota
Study officials:
affiliation: North Shore Therapeutics
name: Sunny X Tang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andreasen NC. The Scale for the Assessment of Negative Symptoms (SANS): conceptual and theoretical foundations. Br J Psychiatry Suppl. 1989 Nov;(7):49-58. No abstract available.
citation: Ascher-Svanum H, Zhu B, Faries DE, Salkever D, Slade EP, Peng X, Conley RR. The cost of relapse and the predictors of relapse in the treatment of schizophrenia. BMC Psychiatry. 2010 Jan 7;10:2. doi: 10.1186/1471-244X-10-2.
citation: Carbon M, Correll CU. Thinking and acting beyond the positive: the role of the cognitive and negative symptoms in schizophrenia. CNS Spectr. 2014 Dec;19 Suppl 1:38-52; quiz 35-7, 53. doi: 10.1017/S1092852914000601. Epub 2014 Nov 18.
citation: Correll CU, Galling B, Pawar A, Krivko A, Bonetto C, Ruggeri M, Craig TJ, Nordentoft M, Srihari VH, Guloksuz S, Hui CLM, Chen EYH, Valencia M, Juarez F, Robinson DG, Schooler NR, Brunette MF, Mueser KT, Rosenheck RA, Marcy P, Addington J, Estroff SE, Robinson J, Penn D, Severe JB, Kane JM. Comparison of Early Intervention Services vs Treatment as Usual for Early-Phase Psychosis: A Systematic Review, Meta-analysis, and Meta-regression. JAMA Psychiatry. 2018 Jun 1;75(6):555-565. doi: 10.1001/jamapsychiatry.2018.0623.
citation: Ford TJ, Buchanan DM, Azeez A, Benrimoh DA, Kaloiani I, Bandeira ID, Hunegnaw S, Lan L, Gholmieh M, Buch V, Williams NR. Taking modern psychiatry into the metaverse: Integrating augmented, virtual, and mixed reality technologies into psychiatric care. Front Digit Health. 2023 Mar 24;5:1146806. doi: 10.3389/fdgth.2023.1146806. eCollection 2023.
citation: Lundin RM, Yeap Y, Menkes DB. Adverse Effects of Virtual and Augmented Reality Interventions in Psychiatry: Systematic Review. JMIR Ment Health. 2023 May 5;10:e43240. doi: 10.2196/43240.
citation: Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.