NCT06358339

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
640

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started May 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
May 2025Dec 2027

First Submitted

Initial submission to the registry

March 20, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

March 20, 2024

Last Update Submit

April 21, 2026

Conditions

Keywords

Psychiatric patientsPost-discharge suicideGamificationMultiphase optimization strategyImplementation science

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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 Outcomes (3)

  • Self-determination at at three months after discharge

    It will be evaluated at one week, one months and three months after discharge.

  • Social connectedness at three month after discharge

    It will be evaluated at one week, one months and three months after discharge.

  • Social support at three months after discharge

    It will be evaluated at one week, one months and three months after discharge.

Other Outcomes (15)

  • Times of re-hospitalization for mental disorders

    It will be evaluated at one week, one months and three months after discharge.

  • Attitudes towards the acceptability of the intervention

    It will be evaluated by three focus group interviews immediately after the confirmation phase, and each interview will be about 60 to 120 minutes.

  • Attitudes towards the adoption of the intervention

    It will be evaluated by three focus group interviews immediately after the confirmation phase, and each interview will be about 60 to 120 minutes.

  • +12 more other outcomes

Study Arms (18)

Routine Tracker, Mind Care, Social Connectivity, and Achievement & Rewards

EXPERIMENTAL

At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. The TEEM app with the intervention condition of Routine Tracker, Mind Care, Social Connectivity, and Achievement \& Rewards.

Other: TEEM

Routine Tracker, Mind Care and Social Connectivity

EXPERIMENTAL

At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. The TEEM app with the intervention condition of Routine Tracker, Mind Care and Social Connectivity.

Other: TEEM

Routine Tracker, Social Connectivity, and Achievement & Rewards

EXPERIMENTAL

At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. The TEEM app with the intervention condition of Routine Tracker, Social Connectivity, and Achievement \& Rewards.

Other: TEEM

Routine Tracker and Achievement & Rewards

EXPERIMENTAL

At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. The TEEM app with the intervention condition of Routine Tracker and Achievement \& Rewards.

Other: TEEM

Routine Tracker and Social Connectivity

EXPERIMENTAL

At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. The TEEM app with the intervention condition of Routine Tracker and Social Connectivity.

Other: TEEM

Routine Tracker and Mind Care

EXPERIMENTAL

At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. The TEEM app with the intervention condition of Routine Tracker and Mind Care.

Other: TEEM

Routine Tracker and Achievement & Reward

EXPERIMENTAL

At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. The TEEM app with the intervention condition of Routine Tracker and Achievement \& Reward.

Other: TEEM

Routine Tracker

EXPERIMENTAL

At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. The TEEM app with the intervention condition of Routine Tracker only.

Other: TEEM

Mind Care, Social Connectivity, and Achievement & Rewards

EXPERIMENTAL

At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. The TEEM app with the intervention condition of Mind Care, Social Connectivity, and Achievement \& Rewards.

Other: TEEM

Mind Care and Social Connectivity

EXPERIMENTAL

At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group The TEEM app with the intervention condition of Mind Care and Social Connectivity.

Other: TEEM

Mind Care and Achievement & Rewards

EXPERIMENTAL

At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. The TEEM app with the intervention condition of Mind Care and Achievement \& Rewards.

Other: TEEM

Mind Care

EXPERIMENTAL

At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. The TEEM app with the intervention condition of Mind Care only.

Other: TEEM

Social Connectivity and Achievement & Rewards

EXPERIMENTAL

At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. The TEEM app with the intervention condition of Social Connectivity and Achievement \& Rewards.

Other: TEEM

Social Connectivity

EXPERIMENTAL

At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. The TEEM app with the intervention condition of Social Connectivity only.

Other: TEEM

Achievement & Rewards

EXPERIMENTAL

At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. The TEEM app with the intervention condition of Achievement \& Rewards only.

Other: TEEM

Brief contact intervention

EXPERIMENTAL

At the optimization phrase, participants will be assigned into Group 1 to Group 16 randomly, with 20 participants in each group. Participants will receive care as usual (receiving brief contact intervention which mention in the study NCT04907669)

Other: TEEM

Optimized TEEM

EXPERIMENTAL

At the confirmation phase, participants will be assigned into Group 17 to Group 18 randomly, with 160 participants in each group. The TEEM app with the optimized intervention condition from the optimization phase.

Other: TEEM

Care as usual

EXPERIMENTAL

At the confirmation phase, participants will be assigned into Group 17 to Group 18 randomly, with 160 participants in each group. Participants will receive care as usual (receiving brief contact intervention which mention in the study NCT04907669)

Other: TEEM

Interventions

TEEMOTHER

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.

Achievement & RewardsBrief contact interventionCare as usualMind CareMind Care and Achievement & RewardsMind Care and Social ConnectivityMind Care, Social Connectivity, and Achievement & RewardsOptimized TEEMRoutine TrackerRoutine Tracker and Achievement & RewardRoutine Tracker and Achievement & RewardsRoutine Tracker and Mind CareRoutine Tracker and Social ConnectivityRoutine Tracker, Mind Care and Social ConnectivityRoutine Tracker, Mind Care, Social Connectivity, and Achievement & RewardsRoutine Tracker, Social Connectivity, and Achievement & RewardsSocial ConnectivitySocial Connectivity and Achievement & Rewards

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Kangning Hospital

Shenzhen, Guangdong, 518020, China

RECRUITING

Related Publications (8)

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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 27905826BACKGROUND
  • 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.

    PMID: 23811172BACKGROUND
  • 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.

    PMID: 22179294BACKGROUND
  • 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.

    PMID: 16097907BACKGROUND
  • 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.

    PMID: 21132416BACKGROUND
  • Hou F, Liu H, Bai Y, Peng B, Chen G, Zhang Y, Wu D, Fu T, Hu L, Li J. Protocol of the Tailored Evidence-based Enhancements in Mental Health-Gamified and Individualized Follow-Up Treatment for Suicide (TEEM-GIFTS): a Multiphase Optimization Strategy (MOST) study implementing a gamified mHealth intervention to reduce postdischarge suicide risk in patients with mental disorders in Shenzhen. BMJ Open. 2025 Apr 15;15(4):e092339. doi: 10.1136/bmjopen-2024-092339.

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Fengsu Hou, Ph.D.

    Shenzhen Kangning Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fengsu Hou, Ph.D.

CONTACT

Huiming Liu, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
After recruitment and the baseline survey, participants will be assigned into Group 1 to Group 16 by simple randomization in R program. The allocation ratio in randomization will be 1:1. Participants, LHSs, nurses who perform recruitment and baseline survey, and investigators who perform follow-ups will be blinded to the assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

March 20, 2024

First Posted

April 10, 2024

Study Start

May 1, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Quantitative data will be publicly available through FigShare 12 months after the main studies are published in peer-reviewed journals. The data will contain deidentified demographic information, primary and secondary outcomes, and other covariate outcomes.

Shared Documents
STUDY PROTOCOL
Time Frame
Twelve months after the main studies are published in peer-reviewed journals. The study protocol will be shared once published in peer-reviewed journal.
Access Criteria
Please contact the PI Fengsu Hou to request for the use of the data, and the requests should include detail contact information of applicants, the purpose of study, and the analysis plan.

Locations