OnTrack>An Online Role-Playing Game: A Small Business Innovation Research (SBIR) Grant

Schizophrenia Clinical Trial

Official title:

OnTrack>An Online Role-Playing Game: A Small Business Innovation Research (SBIR) Grant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415764
• Other study ID #: 1R43MH105013-01
• Status: Completed
• Phase: Phase 1
• First received: March 30, 2015
• Last updated: July 26, 2016
• Start date: June 2015
• Est. completion date: March 2016

Study information

• Verified date: July 2016
• Source: Center for Social Innovation, Massachusetts
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Psychosis
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• Behavioral/Attitudinal OnTrack Role-Playing Game
The intervention will involve each participant sitting down at a computer for approximately one hour (over the course of one week) to complete the prototype game. Users will take on the role of a person who has experienced first-episode psychosis and moves through animated role-playing scenarios, learn practical tips for engaging in care, play mini-games to develop self-advocacy skills, and view stories of hope and recovery (brief video vignettes). While the intervention does not require direct supervision by the research team, technical support will be available for the duration of the study via telephone, instant messaging and email. All participants receive identical baseline surveys and 2-week follow up surveys.

Locations

Country	Name	City	State
United States	Center for Social Innovation	Needham	Massachusetts
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Center for Social Innovation, Massachusetts	Research Foundation for Mental Hygiene, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

Corrigan, P. W., Michaels, P. J., Vega, E., Gause, M., Watson, A. C. & Rusch, N. (2012) Self-stigma of mental illness scale-short form: Reliability and validity. Psychiatric Services, 48(8), 1042-1047.

Herth K. Abbreviated instrument to measure hope: development and psychometric evaluation. J Adv Nurs. 1992 Oct;17(10):1251-9. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in attitudes toward recovery	The Herth Hope Index (HHI) will be employed to assess hope in adults immediately before (Month 9; week 36) and 2 weeks (Month 10; week 40) following game play. The instrument is a 12-item survey adapted from the Herth Hope Scale (HHS) (Herth, 1992). The Recovery Attitudes Questionnaire (RAQ-16) will also be used, which helps consumers identify and think about their beliefs and attitudes toward recovery. The instrument is a 16-item survey that will be employed immediately before (week 36) and 2 weeks after game play (week 40) (Borkin et al, 2000).	Pre and post game play; timeframe: Months 9 and 10 (weeks 36 and 40)	No
Secondary	Sense of stigma and empowerment	(1) The self-stigma of mental illness survey (short form) (Corrigan et al, 2012) and (2) empowerment survey will be used both immediately before game play (weeks 36) and 2-weeks (week 40) following game play (Rogers, 1997).	Month 10 (week 40)	No
Secondary	Increased engagement in treatment	Semi-structured interviews will be conducted with a subset of participants to explore access to treatment and potential barriers.	Post game play; timeframe: Month 10 (week 40)	No
Secondary	Attitudes toward the game	Semi-structured interviews will take place with a subset of participants to explore their experience playing the game and attitudes toward it (e.g. extent to which they can relate to it; satisfaction; usability).	Post game play; timeframe: Month 10 (week 40)	No