Game-based Telehealth Therapeutic Intervention in First Onset Psychosis

Sponsor

Stanford University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04799717

Collaborator

(none)

Enrollment

Location

18.9

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychotic Disorders Schizophrenia Spectrum Disorders	Behavioral: Gaming session

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 Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Game-based Telehealth Therapeutic Intervention in First Onset Psychosis

Actual Study Start Date :

Sep 2, 2021

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Outcome Measures

Primary Outcome Measures

Number of Participants with a Hospitalization [The 15 week participation period]
Review patient's medical record for number of hospitalizations due to psychotic disorder
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 18 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Universtiy	Palo Alto	California	United States	94305

Sponsors and Collaborators

Stanford University

Investigators

Principal Investigator: Janani Venugopalakrishnan, MD MPH, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Janai Venugopalakrishnan, Clinical Assistant Professor, Stanford University

ClinicalTrials.gov Identifier:

NCT04799717

Other Study ID Numbers:

59698

First Posted:

Mar 16, 2021

Last Update Posted:

Jun 3, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Janai Venugopalakrishnan, Clinical Assistant Professor, Stanford University

Telehealth, Therapy, intervention

Video game, CBT-P

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 3, 2022