Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358339
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-20
Brief Title:
TEEM-GIFTS A Gamified mHealth to Reduce Post-Discharge Suicide Risk
Sponsor:
Shenzhen Kangning Hospital
Organization:
Shenzhen Kangning Hospital
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 teams 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 CenterShenzhen 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 α005 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 AndroidiOS 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 n320 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
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 CenterShenzhen 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 α005 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 AndroidiOS 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 n320 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None