Game-based Telehealth Therapeutic Intervention in First Onset Psychosis

Completed

• Conditions: Schizophrenia Spectrum Disorders; Psychotic Disorders

• Registration Number: NCT04799717
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-16
• Study Start: 2021-08-31
• Primary Completion: 2022-09-09
• Study Completion: 2022-09-09
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-05
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

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Exclusion Criteria

-Clinical Diagnosis of Intellectual Disability

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with a Hospitalization	The 15 week participation period	Review patient's medical record for number of hospitalizations due to psychotic disorder
Brief Psychiatric Rating Scale Scores	The 15 week participation period.	Perform the Brief Psychiatric Rating Scale (BPRS). The BPRS is a 21 questionaire of present of mental health symptoms wtih each question scored on a Likert scale of 1-7. A score of 01reflects that a particular question was not assessed and a score of 7 is highest severity of the symptom listed in each individual question. A total score is not calculated.
Patient Session Engagement	The 15 week participation period.	Measure client engagement in treatment by providing a post-session survey. The survey has four questions to solicit client feedback on the therapy session. The clients will answer on a scale of 1-10 with 1 being the lowest and 10 being the highest score. Add all four numbers together to obtain the total score.

Trial Locations

Locations (1)

Stanford Universtiy; 🇺🇸 Palo Alto, California, United States