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OpenTrials
Completed

NCT Number: NCT04799717

Game-based Telehealth Therapeutic Intervention in First Onset Psychosis

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.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford Universtiy

Palo Alto, California, 94305, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gaming session

Behavioral

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2021
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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