NCT04799717

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

August 31, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2022

Completed
Last Updated

January 9, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

February 12, 2021

Last Update Submit

January 5, 2023

Conditions

Keywords

Telehealth, Therapy, interventionVideo game, CBT-P

Outcome Measures

Primary Outcomes (3)

  • Number of Participants with a Hospitalization

    Review patient's medical record for number of hospitalizations due to psychotic disorder

    The 15 week participation period

  • Patient Session Engagement

    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

    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.

Interventions

Gaming sessionBEHAVIORAL

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.

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Clinical Diagnosis of Intellectual Disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Universtiy

Palo Alto, California, 94305, United States

Location

Related Publications (11)

  • Ferrari M, McIlwaine SV, Reynolds JA, Archie S, Boydell K, Lal S, Shah JL, Henderson J, Alvarez-Jimenez M, Andersson N, Boruff J, Nielsen RKL, Iyer SN. Digital Game Interventions for Youth Mental Health Services (Gaming My Way to Recovery): Protocol for a Scoping Review. JMIR Res Protoc. 2020 Jun 24;9(6):e13834. doi: 10.2196/13834.

    PMID: 32579117BACKGROUND
  • Landa Y, Mueser KT, Wyka KE, Shreck E, Jespersen R, Jacobs MA, Griffin KW, van der Gaag M, Reyna VF, Beck AT, Silbersweig DA, Walkup JT. Development of a group and family-based cognitive behavioural therapy program for youth at risk for psychosis. Early Interv Psychiatry. 2016 Dec;10(6):511-521. doi: 10.1111/eip.12204. Epub 2015 Jan 13.

    PMID: 25585830BACKGROUND
  • Peters E, Crombie T, Agbedjro D, Johns LC, Stahl D, Greenwood K, Keen N, Onwumere J, Hunter E, Smith L, Kuipers E. The long-term effectiveness of cognitive behavior therapy for psychosis within a routine psychological therapies service. Front Psychol. 2015 Oct 29;6:1658. doi: 10.3389/fpsyg.2015.01658. eCollection 2015.

    PMID: 26579041BACKGROUND
  • Rasskazova, Elena & Friedberg, Robert. (2016). CBT for psychosis prevention and treatment in youth. Current Psychiatry Reviews. 12.

    BACKGROUND
  • Stafford MR, Jackson H, Mayo-Wilson E, Morrison AP, Kendall T. Early interventions to prevent psychosis: systematic review and meta-analysis. BMJ. 2013 Jan 18;346:f185. doi: 10.1136/bmj.f185.

    PMID: 23335473BACKGROUND
  • Stafford MR, Mayo-Wilson E, Loucas CE, James A, Hollis C, Birchwood M, Kendall T. Efficacy and safety of pharmacological and psychological interventions for the treatment of psychosis and schizophrenia in children, adolescents and young adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 11;10(2):e0117166. doi: 10.1371/journal.pone.0117166. eCollection 2015.

    PMID: 25671707BACKGROUND
  • Stain HJ, Bucci S, Baker AL, Carr V, Emsley R, Halpin S, Lewin T, Schall U, Clarke V, Crittenden K, Startup M. A randomised controlled trial of cognitive behaviour therapy versus non-directive reflective listening for young people at ultra high risk of developing psychosis: The detection and evaluation of psychological therapy (DEPTh) trial. Schizophr Res. 2016 Oct;176(2-3):212-219. doi: 10.1016/j.schres.2016.08.008. Epub 2016 Aug 20.

    PMID: 27554197BACKGROUND
  • Adery LH, Ichinose M, Torregrossa LJ, Wade J, Nichols H, Bekele E, Bian D, Gizdic A, Granholm E, Sarkar N, Park S. The acceptability and feasibility of a novel virtual reality based social skills training game for schizophrenia: Preliminary findings. Psychiatry Res. 2018 Dec;270:496-502. doi: 10.1016/j.psychres.2018.10.014. Epub 2018 Oct 9.

    PMID: 30326433BACKGROUND
  • Yang CY, Lee TH, Lo SC, Beckstead JW. The effects of auditory hallucination symptom management programme for people with schizophrenia: a quasi-experimental design. J Adv Nurs. 2015 Dec;71(12):2886-97. doi: 10.1111/jan.12754. Epub 2015 Aug 18.

    PMID: 26283291BACKGROUND
  • Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.

    PMID: 33539561BACKGROUND
  • Freeman D, Reeve S, Robinson A, Ehlers A, Clark D, Spanlang B, Slater M. Virtual reality in the assessment, understanding, and treatment of mental health disorders. Psychol Med. 2017 Oct;47(14):2393-2400. doi: 10.1017/S003329171700040X. Epub 2017 Mar 22.

    PMID: 28325167BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Janani Venugopalakrishnan, MD MPH

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

February 12, 2021

First Posted

March 16, 2021

Study Start

August 31, 2021

Primary Completion

September 9, 2022

Study Completion

September 9, 2022

Last Updated

January 9, 2023

Record last verified: 2023-01

Locations