Clinical trial NCT04799717: Game-based Telehealth Therapeutic Intervention in First Onset Psychosis
Official title: Game-based Telehealth Therapeutic Intervention in First Onset Psychosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychotic Disorders
Schizophrenia Spectrum Disorders
Keywords: Telehealth, Therapy, intervention
Video game, CBT-P
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 8
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents and young adults ages 10 to 18 years of age with a psychotic disorder diagnosis or report of transient positive symptoms of psychosis that has lasted more than one week over the past year.

Brief summary: The goal is to provide combination of 2 hours of weekly game based telehealth therapeutic intervention along with CBT-P for children identified with first onset psychosis or to be clinically high risk for psychosis thus widening therapeutic services offered. Target outcome measures are improvement in clinical symptoms, treatment engagement, and reduced hospitalization rates.

Detailed description: Patients with first onset psychosis or clinical high risk for psychosis often have significant functional decline affecting social, academic, and daily living skills. Given their constellation of new onset psychotic symptoms of paranoia, delusions, hallucinations, and additionally co-morbid anxiety, or depression, patients most often present with school refusal, social withdrawal, aggression, poor self-care, and treatment noncompliance. This leads to decline in quality of life for both patients and families, along with increased sick days, recurrent hospitalizations, residential treatment center admissions which aren't always covered by insurance. Families are often left with very little to intervene and they carry the long-term disease burden of a significant diagnosis in addition to pocketing out of network costs for therapy. Further clinical programs like intensive outpatient programs or partial hospitalization programs often reject candidates with psychosis due to severity of symptoms and low levels of engagement when compared to their counterparts. County services offering in home therapeutic support services like rehabilitation, family therapy, peer support and wrap around services do not apply to insured patients thus causing huge gap in need for services. Early treatment with therapy and medications in first onset psychosis is very valuable as repeatedly shown clinically and in research.

Method: 10 patients in the 10-18 year age group meeting criteria for clinical high risk psychosis and schizophrenia spectrum disorders will be selected using DSM 5 criteria. Patients will be seen twice weekly for 15 weeks. They will be offered weekly individual telehealth therapy using game-based approach for first half of their visit to encourage engagement with therapist. Safe online videogames of their choice will be chosen, allowing usage of computer or electronics during session as needed to serve treatment purposes. The other half of the visit will focus on psychoeducation and utilizing CBT-P components targeting symptoms of psychosis. Patients will be assessed once a month clinically by treating psychiatrist in INSPIRE clinic to track symptom reduction, treatment engagement and hospitalization. Outcome measures will be tracked each month and data compiled between 4/2021-6/2021.

Eligibility criteria: Inclusion criteria is one of the following diagnoses:

* Clinical Diagnosis of Schizophrenia spectrum disorders
* Major Depressive Disorder with Psychotic Features
* Schizophrenia,
* Attenuated psychosis syndrome,
* Brief psychotic disorder,
* Schizoaffective Disorder,
* Schizophreniform disorder
* Unspecified psychotic disorder
* Clinical high risk for psychosis

Exclusion Criteria:

-Clinical Diagnosis of Intellectual Disability

Primary outcomes:
measure: Number of Participants with a Hospitalization
timeFrame: The 15 week participation period
measure: Patient Session Engagement
timeFrame: The 15 week participation period.
measure: Brief Psychiatric Rating Scale Scores
timeFrame: The 15 week participation period.
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Universtiy
state: California
Study officials:
affiliation: Stanford University
name: Janani Venugopalakrishnan, MD MPH
role: PRINCIPAL_INVESTIGATOR
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