TEEM-GIFTS: A Gamified mHealth to Reduce Post-Discharge Suicide Risk

Suicide Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06358339
• Other study ID #: 72374095
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: Shenzhen Kangning Hospital
• Contact: Fengsu Hou, Ph.D.
• Phone: +86-18502864780
• Email: houfengsu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, feasibility, and sustainability 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.

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-G will be developed during the selection phase, and there will be an Android/iOS version of TEEM-G 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 640
• Est. completion date: December 31, 2027
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Suicide

Intervention

Other:
• TEEM
The TEEM app will provide four types of gamified intervention elements as Routine Tracker, Mind Care, Social Connectivity, and Achievement & Rewards which providing services including brief contact intervention, mCBT, health education, venting space, mood sharing, etc. Only enrolled participants have access to log in and use the app.

Locations

Country	Name	City	State
China	Shenzhen Kangning Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Kangning Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View 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. — View 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. — View 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.

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. — View 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. — View Citation

Sebastian Deterding, Dan Dixon, Rilla Khaled, and Lennart Nacke. 2011. From game design elements to gamefulness: defining

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Times of re-hospitalization for mental disorders	Responses to the question "How many times have you been hospitalized for mental disorders" will be recorded and compared.	It will be evaluated at one week, one months and three months after discharge.
Other	Attitudes towards the acceptability of the intervention	This is a mixed methods study, and the investigators will conduct community-based participatory research (CBPR) to evaluate the implementation of the intervention. After the confirmation phase, focus group interviews will be conducted with the CBPR team understand the community's attitudes towards the acceptability of the intervention. Of note, participants (the patients, LHSs, clinical and community mental health providers) are recruited for the qualitative interviews only, who are different from the MOST phases.	It will be evaluated by three focus group interviews immediately after the confirmation phase, and each interview will be about 60 to 120 minutes.
Other	Attitudes towards the adoption of the intervention	This is a mixed methods study, and the investigators will conduct community-based participatory research (CBPR) to evaluate the implementation of the intervention. After the confirmation phase, focus group interviews will be conducted with the CBPR team understand the community's attitudes towards the adoption of the intervention. Of note, participants (the patients, LHSs, clinical and community mental health providers) are recruited for the qualitative interviews only, who are different from the MOST phases.	It will be evaluated by three focus group interviews immediately after the confirmation phase, and each interview will be about 60 to 120 minutes.
Other	The adoption rate of the intervention in patients	The rate will be measured by the number of participants who use the TEEM app divided by the number of participants at the end of the study. Of note, this outcome evaluates the implementation process of the intervention.	It will be evaluated at three months after discharge.
Other	Attitudes towards the equity of the intervention	This is a mixed methods study, and the investigators will conduct community-based participatory research (CBPR) to evaluate the implementation of the intervention. After the confirmation phase, focus group interviews will be conducted with the CBPR team understand the community's attitudes towards the equity of the intervention. Of note, participants (the patients, LHSs, clinical and community mental health providers) are recruited for the qualitative interviews only, who are different from the MOST phases.	It will be evaluated by three focus group interviews immediately after the confirmation phase, and each interview will be about 60 to 120 minutes.
Other	Attitudes towards the feasibility of the intervention	This is a mixed methods study, and the investigators will conduct community-based participatory research (CBPR) to evaluate the implementation of the intervention. After the confirmation phase, focus group interviews will be conducted with the CBPR team understand the community's attitudes towards the feasibility of the intervention. Of note, participants (the patients, LHSs, clinical and community mental health providers) are recruited for the qualitative interviews only, who are different from the MOST phases.	It will be evaluated by three focus group interviews immediately after the confirmation phase, and each interview will be about 60 to 120 minutes.
Other	Attitudes towards the patient-centeredness of the intervention	This is a mixed methods study, and the investigators will conduct community-based participatory research (CBPR) to evaluate the implementation of the intervention. After the confirmation phase, focus group interviews will be conducted with the CBPR team understand the community's attitudes towards the patient-centeredness of the intervention. Of note, participants (the patients, LHSs, clinical and community mental health providers) are recruited for the qualitative interviews only, who are different from the MOST phases.	It will be evaluated by three focus group interviews immediately after the confirmation phase, and each interview will be about 60 to 120 minutes.
Other	Cost for implementing the TEEM-GIFTS	The investigators will develop a checklist to evaluate the fidelity of the overall study. Of note, this outcome evaluates the implementation process of the intervention.	It will be evaluated immediately after the confirmation phase.
Other	Fidelity of the study	The investigators will develop a checklist to evaluate the fidelity of the overall study. Of note, this outcome evaluates the implementation process of the intervention.	It will be evaluated immediately after the confirmation phase.
Other	Efficiency of the intervention	During the confirmation phase, the investigators will record the response speed of the app as experienced by users of TEEM. This term refers to how quickly an application reacts to user inputs or requests. It's a critical aspect of user experience, encompassing everything from tapping a button, swiping through content, to executing a command. Of note, this outcome evaluates the implementation process of the intervention.	It will be evaluated immediately after the confirmation phase.
Other	Attitudes towards the safety of the intervention	This is a mixed methods study, and the investigators will conduct community-based participatory research (CBPR) to evaluate the implementation of the intervention. After the confirmation phase, focus group interviews will be conducted with the CBPR team understand the community's attitudes towards the safety of the intervention. Of note, participants (the patients, LHSs, clinical and community mental health providers) are recruited for the qualitative interviews only, who are different from the MOST phases.	It will be evaluated by three focus group interviews immediately after the confirmation phase, and each interview will be about 60 to 120 minutes.
Other	The timeliness of the intervention	The investigators will record the time for the research team cost to response to participants' requests for crisis intervention and feedbacks.	It will be evaluated immediately after the confirmation phase.
Other	Patients' perceived stigma from baseline to three months after discharge	Perceived stigma will be evaluated the Chinese version of Link Perceived Devaluation-Discrimination Scale. The scale contains 12 items assessing the extent to which a person believes that other people will devalue or discriminate against someone with a mental illness. Each item is on a 4-Likert continuum (from "Strongly disagree" to "Strongly agree") scoring from 1 to 4. A higher total score indicates a higher level of perceived stigma. The total score and its trajectory from baseline to three months after discharge will be recorded and compared.	It will be evaluated at one week, one months and three months after discharge.
Other	Patients' self-efficacy from baseline to three months after discharge	Self-efficacy will be evaluated by the Chinese version of the General Self-Efficacy Scale. The scale contains 10 items, and each item is on a 4-Likert continuum (from "Not at all true" to "Exactly true") scoring from 1 to 4. A higher total score indicates a higher level of self-efficacy. The total score and its trajectory from baseline to three months after discharge will be recorded and compared.	It will be evaluated at one week, one months and three months after discharge.
Other	Patients' compliance to treatment from baseline to three months after discharge	Compliance to treatment will be evaluated by a 4-item self-administered questionnaire. The questionnaire inquires whether the patients take medications under the instruction on prescriptions (frequency, dosage, time, and selfdiscontinued medication). Each item is on a 4-Likert continuum (from "Not following the instruction" to "Exactly following the instruction") scoring from 1 to 4. A higher total score indicates a higher level of compliance to treatment. The total score and its trajectory from baseline to three months after discharge will be recorded and compared.	It will be evaluated at one week, one months and three months after discharge.
Primary	Suicide ideation at three months after discharge	This study will use the Beck Suicide Ideation Scale-Chinese Version (BSI-CV) to assess participants' suicide ideation. The BSI-CV includes 19 items, and each item scores from 0 to 2 with a total score ranging from 0 to 38, and a higher score indicates a higher level of suicide ideation. The total score and its trajectory from baseline to three months after discharge will be recorded and compared.	It will be evaluated at one week, one months and three months after discharge.
Primary	The rate of re-visits to outpatient clinic at three months after discharge	Responses to the question "How many times have you re-visited the outpatient clinic at SKH in the past three months? " will be recorded and compared. In clinic, patients must visit the outpatient clinic one week post-discharge to refill their medication, which can only be prescribed for a maximum of 30 days, resulting in at least four subsequent visits to the clinic. Thus, we define the rate of outpatient clinic revisits as the number of participants who complete all revisits divided by the total number of participants.	It will be evaluated at one week, one months and three months after discharge.
Secondary	Self-determination at at three months after discharge	This study will use the Self-Determination Scale-Chinese Version (SDS) to assess participants' the level of self-determination. The SDS includes 10 items, and each item includes two statements, with scoring options ranging from 'agree only with statement A' to 'agree only with statement B' on a scale of 1-9 with a total score ranging from 10 to 90, and a higher score indicates a higher level of self-determination. The total score and its trajectory from baseline to three months after discharge will be recorded and compared.	It will be evaluated at one week, one months and three months after discharge.
Secondary	Social connectedness at three month after discharge	Social connectedness will be measured by the Social Connectedness Scale (SCS) to evaluate participants' social connected ness after discharge. The SCS is a 20-item scale, and each item is on a 6-Likert continuum (from "Strongly disagree" to "Strongly agree") scoring from 1 to 6. A higher total score indicates a higher level of social connectedness. The total score and its trajectory from baseline to three months after discharge will be recorded and compared.	It will be evaluated at one week, one months and three months after discharge.
Secondary	Social support at three months after discharge	Social support will be measured by the 23-item Duke Social Support Index (DSSI) to evaluate participants' social support after discharge. The DSSI investigates social support by social interaction, perceived social support and instrumental social support. Every answer has been assigned a score, and the total reflects the sum of the items ranging from 11 to 45. A higher total score indicates a higher level of social support. The total score and its trajectory from baseline to three months after discharge will be recorded and compared.	It will be evaluated at one week, one months and three months after discharge.