PsychosisPhase 1NCT02415764
OnTrack>An Online Role-Playing Game: A Small Business Innovation Research (SBIR) Grant
A Phase 1 study testing Behavioral/Attitudinal OnTrack Role-Playing Game in people with Psychosis and Schizoaffective Disorder, run by Center for Social Innovation, Massachusetts at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosis, Schizoaffective Disorder, Schizophrenia
- What is being tested?
- Behavioral/Attitudinal OnTrack Role-Playing Game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2015to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- non-English speaker;
- not clinically stable (at risk of self harming or others, and/or experiencing elevated symptoms) and incapable of providing informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Social Innovation
Needham, Massachusetts, 02494
New York State Psychiatric Institute
New York, New York, 10032
About this study
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.
Read the 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.
- Conditions
- Psychosis, Schizoaffective Disorder, Schizophrenia
- Being tested
- Behavioral/Attitudinal OnTrack Role-Playing Game
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral/Attitudinal OnTrack Role-Playing GameBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilot test Intervention OnTrack>The Game | Other | Consumers who have been referred to OnTrackNY sites at Washington Heights Community Service or Mental Health Association Westchester in the past six months will be recruited to participate in a product evaluation of OnTrack>The Game.
Intervention: This is a behavioral/attitudinal intervention, using OnTrack>The Game, which will include 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). Receives: Behavioral: Behavioral/Attitudinal OnTrack Role-Playing Game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Pre and post game play; timeframe: Months 9 and 10 (weeks 36 and 40)
Secondary outcomes (3)
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).
Measured: Month 10 (week 40)
Increased engagement in treatment
Semi-structured interviews will be conducted with a subset of participants to explore access to treatment and potential barriers.
Measured: Post game play; timeframe: Month 10 (week 40)
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).
Measured: Post game play; timeframe: Month 10 (week 40)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Social Innovation, Massachusetts
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation for Mental Hygiene, Inc.
- Responsible party
- Sponsor
- Investigators
- Jeffrey Olivet, MA, Principal investigator, Center for Social Innovation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415764
- Sponsor's protocol ID
- 1R43MH105013-01
- Status last verified
- Jul 2016
- First submitted
- 30 Mar 2015
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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 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.
PubMed 22578819Herth 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.
PubMed 1430629Rogers 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.
PubMed 9255837
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OnTrack>An Online Role-Playing Game: A Small Business Innovation Research (SBIR) Grant
- ClinicalTrials.gov ID
- NCT02415764
- Acronym / sponsor ID
- 1R43MH105013-01
- Conditions
- Psychosis, Schizoaffective Disorder, Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Center for Social Innovation, MassachusettsUniversity, hospital or other
- Collaborators
- Research Foundation for Mental Hygiene, Inc.
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot test Intervention OnTrack>The Game | Other | Behavioral: Behavioral/Attitudinal OnTrack Role-Playing GameConsumers who have been referred to OnTrackNY sites at Washington Heights Community Service or Mental Health Association Westchester in the past six months will be recruited to participate in a product evaluation of OnTrack>The Game. Intervention: This is a behavioral/attitudinal intervention, using OnTrack>The Game, which will include 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). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- non-English speaker;
- not clinically stable (at risk of self harming or others, and/or experiencing elevated symptoms) and incapable of providing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral/Attitudinal OnTrack Role-Playing GameThe 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. | Behavioural | Pilot test Intervention OnTrack>The Game |
Primary outcome
Changes in attitudes toward recovery
Time frame: Pre and post game play; timeframe: Months 9 and 10 (weeks 36 and 40)
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).
3 secondary outcomes
Sense of stigma and empowerment
Time frame: Month 10 (week 40)
Increased engagement in treatment
Time frame: Post game play; timeframe: Month 10 (week 40)
Attitudes toward the game
Time frame: Post game play; timeframe: Month 10 (week 40)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- BackgroundBorkin, 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
- Background: PubMed 22578819Corrigan 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.
- Background: PubMed 1430629Herth 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.
- Background: PubMed 9255837Rogers 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Olivet, MA principal investigator
Center for Social Innovation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Behavioral/Attitudinal OnTrack Role-Playing Game in people with Psychosis and Schizoaffective Disorder, run by Center for Social Innovation, Massachusetts at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in attitudes toward recovery (time frame: Pre and post game play; timeframe: Months 9 and 10 (weeks 36 and 40)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02415764, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2016.