Clinical trial NCT06358339: TEEM-GIFTS: a Gamified MHealth to Reduce Post-Discharge Suicide Risk
Official title: The Tailored Evidence-based Enhancements in Mental Health-Gamified and Individualized Follow-Up Treatment for Suicide (TEEM-GIFTS) : Implementing a Gamified MHealth Intervention to Reduce Post-Discharge Suicide Risk in Patients with Mental Disorders Using Multiphase Optimization Strategy (MOST)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicide
Keywords: Psychiatric patients
Post-discharge suicide
Gamification
Multiphase optimization strategy
Implementation science
Lead sponsor: Shenzhen Kangning Hospital
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. At the confirmation phase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. At the confirmation phase, participants will be assigned into Group 17 to Group 18 randomly, with 160 participants in each group.
Primary purpose: PREVENTION

Brief summary: Patients with mental disorders are at significantly higher risk of suicide after discharge compared to the general population and patients with other diseases. Currently, there is a lack of post-discharge community suicide risk management services in China. The research team's preliminary research suggests that mHealth interventions are well-accepted and feasible for reducing the suicide risk in patients with mental disorders. Furthermore, the inclusion of gamification elements can enhance treatment adherence and user engagement. However, determining the appropriate combination of gamification elements and evaluating the implementation effectiveness of gamified mHealth interventions for suicide risk are challenges in transforming these into regular community mental health services. This study will leverage gamification theory and community-based participatory research to design a gamified mHealth intervention model aimed at reducing suicide risk among discharged patients with mental disorders, and to develop a corresponding management strategy. Using the multi-phase optimization strategy (MOST), the study will identify the optimal combination of gamification elements to reduce suicide risk and increase the outpatient follow-up rate. Through an implementation science framework, the investigators will evaluate the process, outcomes, cost, and feasibility of this management strategy with the goal of reducing suicide risk among these patients. The findings from this study will provide a scientific basis for innovative suicide risk management models for discharged patients with mental disorders in China, thereby paving the way for the application of implementation science in mental health.

Detailed description: The Tailored Evidence-based Enhancements in Mental health (TEEM) projects, adhering to implementation science principles, encompass various studies aimed at improving mental health care in China. Among these is the Gamified and Individualized Follow-Up Treatment for Suicide (GIFTS) study. Based on the multi-phase optimization strategy (MOST), this is a mixed-methods study with three phases. The selection phase involves forming the gamified mHealth suicide risk management strategy and system through community participatory research. The optimization phase involves testing and adjusting the intervention elements for the gamified mHealth strategy through a factorial design randomized controlled trial (RCT) to evaluate the effectiveness of different combinations of intervention elements in reducing suicide risk. The confirmation phase will assess the optimized strategy based on the Implementation Outcomes Framework (IOF), focusing primarily on patient outcomes obtained through a standard RCT.

1. Selection phase Based on literature review, the research team has identified several gamification elements, including avatar, points, badges, missions, level \& leaderboards, team mates \& team missions, venting space, mood sharing, achievement and titles, and rewards, etc. During developing the gamification mHealth app (TEEM), the investigators categorize the elements into four types of intervention elements as Routine Tracker, Mind Care, Social Connectivity, and Achievement \& Rewards; meanwhile, under the community-based participatory research (CBPR) framework, the investigators aim to explore the appropriate content of gamification mHealth interventions, the acceptance and feasibility of such interventions among discharged psychiatric patients, as well as structural and perceptual barriers during implementation.

   In specific, the research team will recruit discharged patients with mental disorders and their lay health care supporters (LHSs) who are usually their family members, psychiatrists and nurses, psycho-crisis intervention team members, community mental health workers and mental health social workers as the community team, and will categorize the community team into three sub-groups, the patients-LHSs group, the clinic mental health service provider group (psychiatrists and nurses, and psycho-crisis intervention team members), and the community mental health service provider group (community mental health workers and mental health social workers). The investigators will conduct three focus group interviews in each sub-group and ten to fifteen cases of individual in-depth interview with the community to avoid bias in focus groups and to protect privacy related to personal experience in suicide and suicide intervention. There will be scheduled meetings with the community to discuss and revise the intervention strategy before implementation. Purposive sampling will be applied to recruit participants for the community team. For each type of sub-group, there will be five to eight members
2. Optimization phase The research team will conduct a a factorial design randomized controlled trial (RCT) to evaluate the effectiveness of different combinations of intervention elements in reducing suicide risk. There are four intervention elements as mentioned, thus there will be 16 groups in the factorial design RCT. The research team will recruit discharged patients with mental disorders from Shenzhen Mental Health Center/Shenzhen Kangning Hospital (SKH).

   The research team sets the standard for optimizing interven elements as follows: The experimental group implementing the intervention element and the experimental group not implementing the intervention element should have an effect difference in reducing the suicide risk by 35%, which will be used as the basis for calculating the sample size of this study. This study aims to detect a 35% difference (δ) in the implementation of the intervention elements with a test level of α=0.05 and a test power (1-β) of 80%. A total of 260 patients need to be recruited for this study. Assuming a loss to follow-up rate of 20% and considering the number of experimental groups, the final sample size is 320 patients.

   In accordance with the factorial design, the optimization phase will consist of 16 groups, and this is due to the four types of intervention elements and their 16 possible intervention conditions. Thus, after recruitment and the baseline survey, participants will be assigned into Group 1 to Group 16 by simple randomization in R program, with 20 participants in each group. Further, participants in each group will only have access to a single intervention condition of elements assigned to their group. Noted, the intervention app TEEM will be developed during the selection phase, and there will be an Android/iOS version of TEEM and a mini-program in the WeChat platform. Participants, LHSs, nurses who perform recruitment and baseline survey, and investigators who perform follow-ups will be blinded to the assignment.

   To evaluate post-discharge suicide risk more cautiously and to provide crisis intervention in time, face-to-face interview will be conducted to collect information. Trained nurses in SKH will recruit participants and perform baseline survey. The research assistants will contact participants, schedule visits to SKH out-patient clinics , and complete follow-up questionnaires after out-patient visits at one week, one month, and three months after discharge. If participants refused subsequent visits, the investigators would schedule home visits to complete the survey by research assistants and community mental health workers. The condition that resulted in the greatest decrease in participants' suicide risk three months after discharge is the optimized intervention condition.
3. Confirmation phase This phase will assess the optimized intervention, focusing primarily on patient outcomes obtained through a standard RCT, in which intervention group (Group 17) will receive the optimized intervention condition and the control group (Group 18) will receive care as usual. Similar to the optimization phase, the research team will recruit discharged patients with mental disorders from SKH. The sample size (n=320) and randomization process will be consistent with optimization phase. Data collection, baseline survey and follow-up schedule are similar to the optimization phase. The primary outcomes are suicide risk and the rate of re-visits to outpatient clinic at three months after discharge. Secondary outcomes will be illustrated later in the Outcome measures section.
4. Study outcomes and measurements The implementation outcomes of the overall project are based on the Implementation Outcomes Framework, in which detailed primary and secondary outcomes of the study will be collected at 3 months after discharge.

Eligibility criteria: Inclusion Criteria:

For patients

* Being 18 years and above;
* Being diagnosed with mental disorders;
* Having received inpatient care for three days or more;
* Living in Shenzhen and having no plan to leave Shenzhen in the following 12 months after discharge;
* Being able to use apps or WeChat (WeChat mini program) on smart phones.

For lay health care supporters (LHSs)

* Being 18 years and above;
* Being without any diagnosis of mental disorder;
* Being the lay health care supporter in the family;
* Living in Shenzhen and having no plan to leave Shenzhen in the following 12 months after discharge;
* Being able to use apps or WeChat (WeChat mini program) on smart phones.

For the clinic and community mental health service providers

* Being 18 years and above;
* Having practiced in mental health service at least for 12 months.

Exclusion criteria For patients

* Refusing to provide written consent or be unable to provide written consent due to any cognitive problems.
* Being discharged by the patient's or LHSs' demand against medical advice.
* With no ID, no stable residence nor any source of income.

For For lay health care supporters (LHSs)

* Refusing to provide written consent.

For the clinic and community mental health service providers

* Refusing to provide written consent.

Primary outcomes:
measure: Suicide ideation at three months after discharge
timeFrame: It will be evaluated at one week, one months and three months after discharge.
measure: The rate of re-visits to outpatient clinic at three months after discharge
timeFrame: It will be evaluated at one week, one months and three months after discharge.
Secondary outcomes:
measure: Self-determination at at three months after discharge
timeFrame: It will be evaluated at one week, one months and three months after discharge.
measure: Social connectedness at three month after discharge
timeFrame: It will be evaluated at one week, one months and three months after discharge.
measure: Social support at three months after discharge
timeFrame: It will be evaluated at one week, one months and three months after discharge.
Other outcomes:
measure: Times of re-hospitalization for mental disorders
timeFrame: It will be evaluated at one week, one months and three months after discharge.
measure: Attitudes towards the acceptability of the intervention
timeFrame: It will be evaluated by three focus group interviews immediately after the confirmation phase, and each interview will be about 60 to 120 minutes.
measure: Attitudes towards the adoption of the intervention
timeFrame: It will be evaluated by three focus group interviews immediately after the confirmation phase, and each interview will be about 60 to 120 minutes.
measure: The adoption rate of the intervention in patients
timeFrame: It will be evaluated at three months after discharge.
measure: Attitudes towards the equity of the intervention
timeFrame: It will be evaluated by three focus group interviews immediately after the confirmation phase, and each interview will be about 60 to 120 minutes.
measure: Attitudes towards the feasibility of the intervention
timeFrame: It will be evaluated by three focus group interviews immediately after the confirmation phase, and each interview will be about 60 to 120 minutes.
measure: Attitudes towards the patient-centeredness of the intervention
timeFrame: It will be evaluated by three focus group interviews immediately after the confirmation phase, and each interview will be about 60 to 120 minutes.
measure: Cost for implementing the TEEM-GIFTS
timeFrame: It will be evaluated immediately after the confirmation phase.
measure: Fidelity of the study
timeFrame: It will be evaluated immediately after the confirmation phase.
measure: Efficiency of the intervention
timeFrame: It will be evaluated immediately after the confirmation phase.
measure: Attitudes towards the safety of the intervention
timeFrame: It will be evaluated by three focus group interviews immediately after the confirmation phase, and each interview will be about 60 to 120 minutes.
measure: The timeliness of the intervention
timeFrame: It will be evaluated immediately after the confirmation phase.
measure: Patients' perceived stigma from baseline to three months after discharge
timeFrame: It will be evaluated at one week, one months and three months after discharge.
measure: Patients' self-efficacy from baseline to three months after discharge
timeFrame: It will be evaluated at one week, one months and three months after discharge.
measure: Patients' compliance to treatment from baseline to three months after discharge
timeFrame: It will be evaluated at one week, one months and three months after discharge.
Locations:
city: Shenzhen
country: China
facility: Shenzhen Kangning Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen Kangning Hospital
name: Fengsu Hou, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sebastian Deterding, Dan Dixon, Rilla Khaled, and Lennart Nacke. 2011. From game design elements to gamefulness: defining
citation: Deci EL, Ryan RM, Handbook of self-determination research[M/OL]. Rochester, NY: University Rochester Press, 2002. https://psycnet.apa.org/record/2002-01702-000.
citation: Hopia H, Raitio K. Gamification in Healthcare: Perspectives of Mental Health Service Users and Health Professionals. Issues Ment Health Nurs. 2016 Dec;37(12):894-902. doi: 10.1080/01612840.2016.1233595. Epub 2016 Dec 1.
citation: Christensen H, Farrer L, Batterham PJ, Mackinnon A, Griffiths KM, Donker T. The effect of a web-based depression intervention on suicide ideation: secondary outcome from a randomised controlled trial in a helpline. BMJ Open. 2013 Jun 28;3(6):e002886. doi: 10.1136/bmjopen-2013-002886.
citation: Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: understanding time lags in translational research. J R Soc Med. 2011 Dec;104(12):510-20. doi: 10.1258/jrsm.2011.110180.
citation: Collins LM, Murphy SA, Nair VN, Strecher VJ. A strategy for optimizing and evaluating behavioral interventions. Ann Behav Med. 2005 Aug;30(1):65-73. doi: 10.1207/s15324796abm3001_8.
citation: Collins LM, Baker TB, Mermelstein RJ, Piper ME, Jorenby DE, Smith SS, Christiansen BA, Schlam TR, Cook JW, Fiore MC. The multiphase optimization strategy for engineering effective tobacco use interventions. Ann Behav Med. 2011 Apr;41(2):208-26. doi: 10.1007/s12160-010-9253-x.