An Implementation Study of Suicide Risk Management Among Discharged Psychiatric Patients

NCT04907669 | Completed

• 1 other identifier: 72004140
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 1

Brief Summary

The post-discharge suicide risk among psychiatric patients is significantly higher than it among patients with other diseases and general population. The brief contact interventions (BCIs) are recommended to decrease the risk in areas with limited mental health service resource like China, however the best frequency to implement BCIs is unknown. This implementation study aims to 1) to develop an intervention strategy against post-discharge suicide based on BCIs for Chinese psychiatric patients; 2) to determine the best frequency of BCIs based on Sequential Multiple Assignment Randomized Trial; 3) to evaluate the effectiveness of the intervention strategy and explore its implementability based on the Implementation Outcome Framework (IOF). Based on the community-based participatory research (CBPR) approach, this study will invite psychiatric patients and family members, psychiatrist and nurses, community mental health workers and social workers as the community team to develop a post-discharge suicide intervention strategy. The study will recruit patients with psychotic symptoms and with major depressive disorder discharged from Shenzhen Kangning Hospital (SKH) in a Sequential Multiple Assignment Randomized Trial (SMART) to determine the best frequency for implementing BCIs and to evaluate the effectiveness. Participants will be randomized into two intervention groups to receive BCIs at different frequencies. Follow-ups to evaluate participants' suicide risk are scheduled at 1, 3, 6 and 12 months after discharge. The re-randomization will be applied at 3 months after discharge. With the Intent-to-treat (ITT) approach, generalized estimating equation (GEE) and survival analysis (SA) will be applied to compare the effectiveness among groups and to explore factors associated with suicide risk. Meanwhile, this study will collect qualitative and quantitative information on implementation and service outcomes from the community team.

Conditions

Suicide

Keywords

Psychiatric patients; Post-discharge suicide; Brief contact interventions; Sequential multiple assignment randomized trial; Implementation science

Outcome Measures

Primary Outcomes (2)

• The trajectory of suicide ideation from baseline to 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's trajectory from baseline to three months after discharge will be recorded and compared.

  It will be evaluated at three months after discharge.

• The trajectory of suicide ideation from baseline to 12 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's trajectory from baseline to 12 months after discharge will be recorded and compared.

  It will be evaluated at 12 months after discharge.

Secondary Outcomes (5)

• The trajectory of social connectedness from baseline to three month after discharge

  It will be evaluated at three months after discharge.

• The trajectory of social connectedness from baseline to 12 months after discharge

  It will be evaluated at 12 months after discharge.

• The trajectory of social support from baseline to three months after discharge

  It will be evaluated at one month after discharge.

• The trajectory of social support from baseline to 12 months after discharge

  It will be evaluated at 12 months after discharge.

• The trajectory of suicide ideation from three months after discharge to 12 months after discharge

  It will be evaluated at 12 months after discharge.

Other Outcomes (20)

• Times of re-hospitalization for mental disorders

  It will be evaluated at 12 months after discharge.

• The usage of crisis intervention

  It will be evaluated at 12 months after discharge.

• Attitudes towards the acceptability of the intervention

  It will be evaluated by three focus group interviews during the implementation of the SMART trial, and each interview will be about 60 to 120 minutes.

Study Arms (6)

Group 1a

EXPERIMENTAL

After recruitment and baseline survey, participants will be randomized into Group 1 and Group 2. In Group 1, participants will receive brief contact intervention (BCI) monthly. If participants' suicide risk increased at 3 months after discharge, they will be re-randomized into Group 1a and Group 1b to receive BCIs weekly (Group 1a) and bi-weekly (Group 1b).

Other: Brief contact intervention

Group 1b

EXPERIMENTAL

After recruitment and baseline survey, participants will be randomized into Group 1 and Group 2. In Group 1, participants will receive brief contact intervention (BCI) monthly. If participants' suicide risk increased at 3 months after discharge, they will be re-randomized to receive BCIs weekly (Group 1a) and bi-weekly (Group 1b).

Other: Brief contact intervention

Group 1c

EXPERIMENTAL

After recruitment and baseline survey, participants will be randomized into Group 1 and Group 2. In Group 1, participants will receive brief contact intervention (BCI) monthly. If participants' suicide risk decreased or did not change, they will remain receiving BCIs monthly as Group 1c.

Other: Brief contact intervention

Group 2a

EXPERIMENTAL

After recruitment and baseline survey, participants will be randomized into Group 1 and Group 2. In Group 2, participants will receive brief contact intervention (BCI) weekly. If the suicide risk increased or did not change, they will remain receiving BCIs weekly as Group 2a.

Other: Brief contact intervention

Group 2b

EXPERIMENTAL

After recruitment and baseline survey, participants will be randomized into Group 1 and Group 2. In Group 2, participants will receive brief contact intervention (BCI) weekly. If the suicide risk decreased, they will be re-randomized to receive BCIs monthly (Group 2b) and bi-weekly (Group 2c).

Other: Brief contact intervention

Group 2c

EXPERIMENTAL

After recruitment and baseline survey, participants will be randomized into Group 1 and Group 2. In Group 2, participants will receive brief contact intervention (BCI) weekly. If the suicide risk decreased, they will be re-randomized to receive BCIs monthly (Group 2b) and bi-weekly (Group 2c).

Other: Brief contact intervention

Interventions

Brief contact intervention OTHER

The BCI in this study is a series of structured messages, and messages will be delivered to participants by pushing feeds through WeChat and an iOS/Android application developed for this study. If participants did not use smartphones, messages will be delivered by mobile text messages or by phone calls. Though the final details are yet to be determined by the CBPR study, the investigators expect to structure messages into six components including introduction, greetings for previous complains, mental health promotion, encouragement, and coping strategies, remind of treatment and subsequent visit, and crisis intervention resource. Noted, the same messages will also be sent to patients' LHSs.

Group 1a; Group 1b; Group 1c; Group 2a; Group 2b; Group 2c

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For patients in the SMART trial and qualitative interviews
• Being 18 years and above;
• Being diagnosed with psychotic symptoms or MDD;
• Having received in-patient 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 read text messages, answer phone calls on mobile phones, use WeChat or any application on smart phones.
• For lay health care supporters (LHSs) in qualitative interviews
• 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 read text messages, answer phone calls on mobile phones, use WeChat or any application on smart phones.
• For the clinic and community mental health service providers in qualitative interviews
• Being 18 years and above;
• Having practiced in mental health service at least for 12 months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Kangning Hospital: lead

Study Sites (1)

Shenzhen Kangning Hospital

Shenzhen, Guangdong, 518020, China

Location

Related Publications (12)

• Goldacre M, Seagroatt V, Hawton K. Suicide after discharge from psychiatric inpatient care. Lancet. 1993 Jul 31;342(8866):283-6. doi: 10.1016/0140-6736(93)91822-4.

  PMID: 8101307 BACKGROUND

• Geddes JR, Juszczak E. Period trends in rate of suicide in first 28 days after discharge from psychiatric hospital in Scotland, 1968-92. BMJ. 1995 Aug 5;311(7001):357-60. doi: 10.1136/bmj.311.7001.357.

  PMID: 7640540 BACKGROUND

• Meehan J, Kapur N, Hunt IM, Turnbull P, Robinson J, Bickley H, Parsons R, Flynn S, Burns J, Amos T, Shaw J, Appleby L. Suicide in mental health in-patients and within 3 months of discharge. National clinical survey. Br J Psychiatry. 2006 Feb;188:129-34. doi: 10.1192/bjp.188.2.129.

  PMID: 16449699 BACKGROUND

• Haglund A, Lysell H, Larsson H, Lichtenstein P, Runeson B. Suicide Immediately After Discharge From Psychiatric Inpatient Care: A Cohort Study of Nearly 2.9 Million Discharges. J Clin Psychiatry. 2019 Feb 12;80(2):18m12172. doi: 10.4088/JCP.18m12172.

  PMID: 30758922 BACKGROUND

• Chung D, Hadzi-Pavlovic D, Wang M, Swaraj S, Olfson M, Large M. Meta-analysis of suicide rates in the first week and the first month after psychiatric hospitalisation. BMJ Open. 2019 Mar 23;9(3):e023883. doi: 10.1136/bmjopen-2018-023883.

  PMID: 30904843 BACKGROUND

• Fleischmann A, Bertolote JM, Wasserman D, De Leo D, Bolhari J, Botega NJ, De Silva D, Phillips M, Vijayakumar L, Varnik A, Schlebusch L, Thanh HT. Effectiveness of brief intervention and contact for suicide attempters: a randomized controlled trial in five countries. Bull World Health Organ. 2008 Sep;86(9):703-9. doi: 10.2471/blt.07.046995.

  PMID: 18797646 BACKGROUND

• Zalsman G, Hawton K, Wasserman D, van Heeringen K, Arensman E, Sarchiapone M, Carli V, Hoschl C, Barzilay R, Balazs J, Purebl G, Kahn JP, Saiz PA, Lipsicas CB, Bobes J, Cozman D, Hegerl U, Zohar J. Suicide prevention strategies revisited: 10-year systematic review. Lancet Psychiatry. 2016 Jul;3(7):646-59. doi: 10.1016/S2215-0366(16)30030-X. Epub 2016 Jun 8.

  PMID: 27289303 BACKGROUND

• Motto JA, Bostrom AG. A randomized controlled trial of postcrisis suicide prevention. Psychiatr Serv. 2001 Jun;52(6):828-33. doi: 10.1176/appi.ps.52.6.828.

  PMID: 11376235 BACKGROUND

• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.

  PMID: 20957426 BACKGROUND

• Lei H, Nahum-Shani I, Lynch K, Oslin D, Murphy SA. A "SMART" design for building individualized treatment sequences. Annu Rev Clin Psychol. 2012;8:21-48. doi: 10.1146/annurev-clinpsy-032511-143152. Epub 2011 Dec 12.

  PMID: 22224838 BACKGROUND

• Fu T, Liu H, Chen C, Zhang B, Chen G, Bai Y, Li J, Hou F. Preventing post-discharge suicides in psychiatric patients: insights from patients, lay healthcare supporters, and mental health professionals-a qualitative analysis. BMC Public Health. 2024 Jan 2;24(1):64. doi: 10.1186/s12889-023-17475-w.

  PMID: 38166746 DERIVED

• Liu H, Chen G, Li J, Hao C, Zhang B, Bai Y, Song L, Chen C, Xie H, Liu T, Caine ED, Hou F. Sequential multiple assignment randomised trial of a brief contact intervention for suicide risk management among discharged psychiatric patients: an implementation study protocol. BMJ Open. 2021 Nov 26;11(11):e054131. doi: 10.1136/bmjopen-2021-054131.

  PMID: 34836907 DERIVED

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Fengsu Hou, Ph.D.

  Shenzhen Kangning Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: After recruitment and the baseline survey, we will assign participants into Group 1 and Group 2 by block randomization in R program. At the check point in the SMART trial, we will re-assign participants into Group 1a, Group 1b, Group 1c, Group 2a, Group 2b, and Group 2c based on their suicide risk by simple randomization in R program. The allocation ratio in randomization will be 1:1. The randomization will be performed by a statistician in the research team. Patients, LHSs, nurses who perform recruitment and baseline survey, the statistician who performs randomization, and investigators who perform follow-ups will be blinded to the assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Model Details: After recruitment and baseline survey, participants will be randomized into two groups Group 1 and Group 2 where BCIs will be implemented monthly and weekly. Participants' suicide risk will be evaluated at three months after discharge. At the check point, for participants in Group 1, if the suicide risk increased, they will be re-randomized into Group 1a and Group 1b where BCIs will be implemented weekly and bi-weekly; otherwise, they will remain receiving BCIs monthly as Group 1c. For participants in Group 2, if the suicide risk increased or did not change, they will remain receiving BCIs weekly as Group 2a; otherwise, they will be re-randomized into Group 2b and Group 2c where BCIs will be implemented monthly and bi-weekly.

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: June 1, 2021
• Study Start: January 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• 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

CN (1)