OnTrack>An Online Role-Playing Game for Young People With First Episode Psychosis

NCT03390491 | Completed DMC

• 2 other identifiers: #76432R44MH105013-02
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The research team will develop and test a prototype version of OnTrack\>An Online Role-Playing Game (OnTrack\>The Game or OTG), an online role-playing game designed for youth and young adults experiencing First Episode Psychosis (FEP). Phase I showed positive changes in quantitative measures of hope and recovery, as well as an enthusiastic response to the prototype as evidenced by qualitative interviews. In Phase II, the research team will refine, expand and finalize OTG and evaluate the effectiveness of OTG.

Conditions

Psychosis; Schizoaffective Disorder; Schizophrenia

Outcome Measures

Primary Outcomes (3)

• Change in Treatment Engagement

  Improved treatment engagement in participants from OTG condition compared to the control condition, RV (measured by a. Signh O'Brien Level of Engagement Scale, b. Engagement with CSC program determined by record review)

  At time point 3 (five months after baseline)

• Empowerment

  Increased empowerment in participants from OTG condition compared to the control condition, RV (measured by: a. Herth Hope Index, b. Recovery Attitude Questionnaire, c. Roger's Empowerment Scale)

  at time point 2 (two months after baseline); and at time point 3 (five months after baseline)

• Stigma

  Decreased stigma concerns in participants from OTG condition compared to the control condition, RV (measured by a. Questionnaire on Anticipated Stigma, b. Rüsch Stigma Stress)

  at time point 3 (five months after baseline)

Secondary Outcomes (1)

• Empowerment and Stigma Mediating Effect on Treatment Engagement

  do increases in empowerment and decreases in stigma concerns at time point 2 (2 months after baseline), mediate the effect of OTG on treatment engagement at time point 3 (5 months after baseline)

Study Arms (2)

OnTrack>TheGame (OTG)

EXPERIMENTAL

Participants randomized to the OTG group (n=100) will have the option to play the online role-playing game for a period of 2 months. They will receive weekly email reminders that the game remains available to them.

Behavioral: OnTrack>TheGame (OTG)

Recovery Videos (RV)

OTHER

Participants randomized to the RV group (n=100) will have the option to visit a website that will contain the recovery videos and the static information that is contained in the game. The RV group will also have 2 months to view the materials on the website and will receive weekly email reminders that the website/videos remain available to them. At the end of the study (after the follow-up assessment), the RV participants will be provided access to the game.

Behavioral: Recovery Videos (RV)

Interventions

OnTrack>TheGame (OTG) BEHAVIORAL

OTG clients will be informed that the game can be played on a computer or a tablet and the time estimate for completing the game is approximately 5-8 hours. OnTrack\>The Game offers players the opportunity to immerse in a fictional neighborhood that centers around four domains for supportive recovery as defined by SAMHSA: health, home, purpose and community. The player interacts with other game characters including new acquaintances, friends/peers, a family member, and a treatment team, allowing the player to practice social and communication skills, while fostering personal relationships and building a support network. Additionally, the game provides players with helpful resources including psychoeducation materials and videos of real people who have experienced a first episode of psychosis, sharing their stories of hope and recovery. As a whole, the game provides a safe environment to promote goal attainment and recovery.

OnTrack>TheGame (OTG)

Recovery Videos (RV) BEHAVIORAL

As described, RV clients will have access to a website that includes recovery videos and static psychoeducation materials. In this condition, mental health providers will also ask about possible reactions to viewing the recovery videos and information on the website.

Recovery Videos (RV)

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Currently enrolled in OnTrackNY
• English speaking
• Clinically stable (not in crisis or experiencing severe or elevated symptoms)
• Capable of providing informed consent
• Regular access to a computer or tablet (at home or at their OnTrack site)
• Working email address and access to email
• Enrolled in OnTrackNY less than 19 months
• Parent or guardian permission for minors (age 16-17)

Sponsors & Collaborators

• Center for Social Innovation, Massachusetts: lead
• Research Foundation for Mental Hygiene, Inc.: collaborator
• New York State Psychiatric Institute: collaborator
• University of Maryland, College Park: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (26)

• Dixon LB, Goldman HH, Bennett ME, Wang Y, McNamara KA, Mendon SJ, Goldstein AB, Choi CW, Lee RJ, Lieberman JA, Essock SM. Implementing Coordinated Specialty Care for Early Psychosis: The RAISE Connection Program. Psychiatr Serv. 2015 Jul;66(7):691-8. doi: 10.1176/appi.ps.201400281. Epub 2015 Mar 16.

  PMID: 25772764 BACKGROUND

• Kane JM, Robinson DG, Schooler NR, Mueser KT, Penn DL, Rosenheck RA, Addington J, Brunette MF, Correll CU, Estroff SE, Marcy P, Robinson J, Meyer-Kalos PS, Gottlieb JD, Glynn SM, Lynde DW, Pipes R, Kurian BT, Miller AL, Azrin ST, Goldstein AB, Severe JB, Lin H, Sint KJ, John M, Heinssen RK. Comprehensive Versus Usual Community Care for First-Episode Psychosis: 2-Year Outcomes From the NIMH RAISE Early Treatment Program. Am J Psychiatry. 2016 Apr 1;173(4):362-72. doi: 10.1176/appi.ajp.2015.15050632. Epub 2015 Oct 20.

  PMID: 26481174 BACKGROUND

• Abdel-Baki A, Lal S, D-Charron O, Stip E, Kara N. Understanding access and use of technology among youth with first-episode psychosis to inform the development of technology-enabled therapeutic interventions. Early Interv Psychiatry. 2017 Feb;11(1):72-76. doi: 10.1111/eip.12250. Epub 2015 May 22.

  PMID: 26011657 BACKGROUND

• Mohr DC, Burns MN, Schueller SM, Clarke G, Klinkman M. Behavioral intervention technologies: evidence review and recommendations for future research in mental health. Gen Hosp Psychiatry. 2013 Jul-Aug;35(4):332-8. doi: 10.1016/j.genhosppsych.2013.03.008. Epub 2013 May 8.

  PMID: 23664503 BACKGROUND

• Shandley K, Austin D, Klein B, Kyrios M. An evaluation of 'Reach Out Central': an online gaming program for supporting the mental health of young people. Health Educ Res. 2010 Aug;25(4):563-74. doi: 10.1093/her/cyq002. Epub 2010 Feb 11.

  PMID: 20150530 BACKGROUND

• Lieberman JA, Dixon LB, Goldman HH. Early detection and intervention in schizophrenia: a new therapeutic model. JAMA. 2013 Aug 21;310(7):689-90. doi: 10.1001/jama.2013.8804. No abstract available.

  PMID: 23989167 BACKGROUND

• Stroup, T. S., Lawrence, R. E., Abbas, A. I., Miller, B. R., Perkins, D. O., Lieberman J. A. (2013). Schizophrenia spectrum and other psychotic disorders. In: R. E. Hales, S. C. Yudofsky, & L. Roberts (Eds.). The American psychiatric publishing textbook of psychiatry (6th ed.). Washington, DC: American Psychiatric Publishing.

  BACKGROUND

• Wu EQ, Birnbaum HG, Shi L, Ball DE, Kessler RC, Moulis M, Aggarwal J. The economic burden of schizophrenia in the United States in 2002. J Clin Psychiatry. 2005 Sep;66(9):1122-9. doi: 10.4088/jcp.v66n0906.

  PMID: 16187769 BACKGROUND

• Baranowski T, Buday R, Thompson DI, Baranowski J. Playing for real: video games and stories for health-related behavior change. Am J Prev Med. 2008 Jan;34(1):74-82. doi: 10.1016/j.amepre.2007.09.027.

  PMID: 18083454 BACKGROUND

• Hieftje K, Edelman EJ, Camenga DR, Fiellin LE. Electronic media-based health interventions promoting behavior change in youth: a systematic review. JAMA Pediatr. 2013 Jun;167(6):574-80. doi: 10.1001/jamapediatrics.2013.1095.

  PMID: 23568703 BACKGROUND

• Armstrong S. Video games on prescription. BMJ. 2014 Sep 15;349:g5615. doi: 10.1136/bmj.g5615. No abstract available.

  PMID: 25224744 BACKGROUND

• Jones CM, Scholes L, Johnson D, Katsikitis M, Carras MC. Gaming well: links between videogames and flourishing mental health. Front Psychol. 2014 Mar 31;5:260. doi: 10.3389/fpsyg.2014.00260. eCollection 2014.

  PMID: 24744743 BACKGROUND

• Perkins DO, Gu H, Boteva K, Lieberman JA. Relationship between duration of untreated psychosis and outcome in first-episode schizophrenia: a critical review and meta-analysis. Am J Psychiatry. 2005 Oct;162(10):1785-804. doi: 10.1176/appi.ajp.162.10.1785.

  PMID: 16199825 BACKGROUND

• Agarkar S. A case of prolonged duration of untreated psychosis: barriers to treatment and strategies to improve the outcome. Clin Schizophr Relat Psychoses. 2012 Apr;6(1):45-8.

  PMID: 22453869 BACKGROUND

• Bottlender R, Sato T, Jager M, Wegener U, Wittmann J, Strauss A, Moller HJ. The impact of the duration of untreated psychosis prior to first psychiatric admission on the 15-year outcome in schizophrenia. Schizophr Res. 2003 Jul 1;62(1-2):37-44. doi: 10.1016/s0920-9964(02)00348-1.

  PMID: 12765741 BACKGROUND

• Goh, D. H., Ang, R. P., & Tan, H. C. (2008). Strategies for designing effective psychotherapeutic gaming interventions for children and adolescents. Computers in Human Behavior, 24(5), 2217-2235.

  BACKGROUND

• Wilkinson N, Ang RP, Goh DH. Online video game therapy for mental health concerns: a review. Int J Soc Psychiatry. 2008 Jul;54(4):370-82. doi: 10.1177/0020764008091659.

  PMID: 18720897 BACKGROUND

• Batson, L., & Feinberg, S. (2006). Game designs that enhance motivation and learning for teenagers. Electronic Journal for the Integration of Technology in Education, 5(1), 34-43.

  BACKGROUND

• Neal, J.W., Neal, Z.P., VanDyke, E., & Kornbluh, M. (2015). Expediting the analysis of qualitative data in evaluation: A procedure for the Rapid Identification of Themes From Audio Recordings (RITA). American Journal of Evaluation, 36(1), 118-132. doi: 10.1177/1098214014536601

  BACKGROUND

• Rusch N, Corrigan PW, Wassel A, Michaels P, Olschewski M, Wilkniss S, Batia K. A stress-coping model of mental illness stigma: I. Predictors of cognitive stress appraisal. Schizophr Res. 2009 May;110(1-3):59-64. doi: 10.1016/j.schres.2009.01.006. Epub 2009 Mar 6.

  PMID: 19269140 BACKGROUND

• 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.

  PMID: 1430629 BACKGROUND

• 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.

  PMID: 9255837 BACKGROUND

• Gabbidon J, Brohan E, Clement S, Henderson RC, Thornicroft G; MIRIAD Study Group. The development and validation of the Questionnaire on Anticipated Discrimination (QUAD). BMC Psychiatry. 2013 Nov 7;13:297. doi: 10.1186/1471-244X-13-297.

  PMID: 24199691 BACKGROUND

• Shortreed SM, Laber E, Scott Stroup T, Pineau J, Murphy SA. A multiple imputation strategy for sequential multiple assignment randomized trials. Stat Med. 2014 Oct 30;33(24):4202-14. doi: 10.1002/sim.6223. Epub 2014 Jun 11.

  PMID: 24919867 BACKGROUND

• Jankowski S, Ferreira K, Mascayano F, Donovan E, Rahim R, Birnbaum ML, Yum-Chan S, Medoff D, Marcogliese B, Fang L, Nicholson T, Dixon L. A Serious Game for Young People With First Episode Psychosis (OnTrack>The Game): Qualitative Findings of a Randomized Controlled Trial. JMIR Ment Health. 2022 Apr 6;9(4):e33526. doi: 10.2196/33526.

  PMID: 35384847 DERIVED

• 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: 33539561 DERIVED

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Bethany Marcogliese, PhD

  Center for Social Innovation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: January 4, 2018
• Study Start: November 1, 2018
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: November 26, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)