Clinical trial NCT02415764: OnTrack>An Online Role-Playing Game: A Small Business Innovation Research (SBIR) Grant
Official title: OnTrack>An Online Role-Playing Game: A Small Business Innovation Research (SBIR) Grant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psychosis
Schizoaffective Disorder
Schizophrenia
Lead sponsor: Center for Social Innovation, Massachusetts
Sponsor class: OTHER
Collaborators: name: Research Foundation for Mental Hygiene, Inc.
First posted: 2015-04-14
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Our team will develop a prototype game (OnTrack\>The Game) in which users play the role of a person who has experienced First Episode Psychosis and move through animated role-playing scenarios, learning practical tips for engaging in care, playing mini-games to develop self- advocacy skills, and seeing stories of hope and recovery (brief video vignettes). The game is designed in an engaging comic book style in which the player is presented with realistic situations designed to promote engagement and the development of trusting relationships.

Following development of the prototype, the investigators will conduct a pilot study to develop preliminary data to determine feasibility of a large-scale Phase 2 effectiveness study. This pilot study aims to demonstrate proof of concept for OnTrack\>The Game. The investigators will recruit a sample of patients/consumers (n=25) from OnTrackNY sites that offer services for those experiencing their first psychotic episode. Quantitative data will be collected through baseline and follow up surveys that utilize instruments to measure knowledge and attitudes about recovery, perceptions of stigma, feelings of empowerment and sense of hopefulness. The investigators will also conduct semi-structured interviews with a subset of participants to explore engagement in treatment and attitudes toward the game.

Detailed description: In light of research supporting early first episode psychosis (FEP) intervention models as well as the efficacy of video gaming to engage young people with FEP in treatment, the connection between the two needs to be explored. A gaming tool for first-episode psychosis has the potential to improve patient care; and, decrease stigma associated with schizophrenia.

Hypothesis:

The investigators hypothesize that Phase 1 of this study will demonstrate that the videogame is comprehensible, engaging and easy to maneuver. The investigators hypothesize that the results from the pilot study will suggest that this technologically innovative tool has potential to enhance positive outcomes of research-tested interventions, such as OnTrackNY, for individuals with FEP.

Approach:

Our team will develop a prototype game (OnTrack\>The Game) in which users play the role of a person who has experienced FEP and move through animated role-playing scenarios, learning practical tips for engaging in care, playing mini-games to develop self- advocacy skills, and seeing stories of hope and recovery (brief video vignettes). The game is designed in an engaging comic book style in which the player is presented with realistic situations designed to promote engagement and the development of trusting relationships.

Following development of the prototype, the investigators will conduct a pilot study to develop preliminary data to determine feasibility of a large-scale Phase 2 effectiveness study. This pilot study aims to demonstrate proof of concept for OnTrack\>The Game. The investigators will recruit a sample of patients/consumers (n=25) from OnTrackNY sites that offer services for those experiencing their first psychotic episode. Quantitative data will be collected through baseline and follow up surveys that utilize instruments to measure knowledge and attitudes about recovery, perceptions of stigma, feelings of empowerment and sense of hopefulness. The investigators will also conduct semi-structured interviews with a subset of participants to explore engagement in treatment and attitudes toward the game.

Eligibility criteria: Inclusion Criteria (Consumers):

* 18 - 30 years of age;
* have experienced a first episode of psychosis;
* have been referred to OnTrack New York in the past 12 months;
* are willing to complete study requirements; and
* provides informed consent

Exclusion Criteria (Consumers):

* non-English speaker;
* not clinically stable (at risk of self harming or others, and/or experiencing elevated symptoms) and incapable of providing informed consent

Primary outcomes:
measure: Changes in attitudes toward recovery
timeFrame: Pre and post game play; timeframe: Months 9 and 10 (weeks 36 and 40)
Secondary outcomes:
measure: Sense of stigma and empowerment
timeFrame: Month 10 (week 40)
measure: Increased engagement in treatment
timeFrame: Post game play; timeframe: Month 10 (week 40)
measure: Attitudes toward the game
timeFrame: Post game play; timeframe: Month 10 (week 40)
Other outcomes:
Locations:
city: Needham
country: United States
facility: Center for Social Innovation
state: Massachusetts
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Center for Social Innovation
name: Jeffrey Olivet, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borkin, J. R., Stefffen, J. J., Ensfield, K. K., Wishnick, H., Wilder, K. & Yangarber, N. (2000) Recovery attitudes questionnaire: Development and evaluation. Psychiatric Rehabilitation Journal, 24(2), 95-102
citation: Corrigan PW, Michaels PJ, Vega E, Gause M, Watson AC, Rusch N. Self-stigma of mental illness scale--short form: reliability and validity. Psychiatry Res. 2012 Aug 30;199(1):65-9. doi: 10.1016/j.psychres.2012.04.009. Epub 2012 May 10.
citation: Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992 Oct;17(10):1251-9. doi: 10.1111/j.1365-2648.1992.tb01843.x.
citation: Rogers ES, Chamberlin J, Ellison ML, Crean T. A consumer-constructed scale to measure empowerment among users of mental health services. Psychiatr Serv. 1997 Aug;48(8):1042-7. doi: 10.1176/ps.48.8.1042.