Game-based Telehealth Therapeutic Intervention in First Onset Psychosis

NCT ID: NCT04799717

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2022-09-09

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.

Conditions

Psychotic Disorders; Schizophrenia Spectrum Disorders

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Gaming session

Participants will be provided the option to play an online game with the clinician for the first half of the session through an online platform.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Janai Venugopalakrishnan

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janani Venugopalakrishnan, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Universtiy

Palo Alto, California, United States

Countries

United States

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Other Identifiers

59698

Identifier Type: -

Identifier Source: org_study_id