Game-based Telehealth Therapeutic Intervention in First Onset Psychosis

January 5, 2023 updated by: Janai Venugopalakrishnan, Stanford University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Stanford Universtiy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with a Hospitalization
Time Frame: The 15 week participation period
Review patient's medical record for number of hospitalizations due to psychotic disorder
The 15 week participation period
Patient Session Engagement
Time Frame: 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.
The 15 week participation period.
Brief Psychiatric Rating Scale Scores
Time Frame: 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.
The 15 week participation period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Janani Venugopalakrishnan, MD MPH, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 9, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 9, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 59698

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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