Suicide Clinical Trial
Official title:
An Implementation Study of Suicide Risk Management Among Discharged Psychiatric Patients Based on Brief Contact Interventions and Sequential Multiple Assignment Randomized Trial
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.
Status | Recruiting |
Enrollment | 624 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: 1. 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. 2. 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. 3. 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. Exclusion criteria for patients in the SMART trial and qualitative interviews - 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. |
Country | Name | City | State |
---|---|---|---|
China | Shenzhen Kangning Hospital | Shenzhen | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Shenzhen Kangning Hospital |
China,
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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 12 months after discharge. | |
Other | The usage of crisis intervention | Responses to the question "How many times have you called the research team or the Crisis Intervention Hotline for help after discharged from hospital?" will be recorded and compared. | It will be evaluated at 12 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. In the second implementation evaluation stage of the study, 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 SMART trial sample. | 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. | |
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. In the second implementation evaluation stage of the study, 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 SMART trial sample. | 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. | |
Other | The adoption rate of the intervention in patients | The rate will be measured by the number of participants who subscribe to follow the study's WeChat Platform and the application divided by the number of participants who remain as followers and users at the end of the study. Of note, this outcome evaluates the implementation process of the intervention. | It will be evaluated after all patients in the SMART trial have been discharged for 12 months. | |
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. In the second implementation evaluation stage of the study, 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 SMART trial sample. | 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. | |
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. In the second implementation evaluation stage of the study, 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 SMART trial sample. | 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. | |
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. In the second implementation evaluation stage of the study, 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 SMART trial sample. | 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. | |
Other | Cost for implementing the SMART trial | The total cost of implementing the SMART trial will be recorded to assess the economic benefits of the intervention. Of note, this outcome evaluates the implementation process of the intervention. | It will be evaluated after all patients in the SMART trial have been discharged for 12 months. | |
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 after all patients in the SMART trial have been discharged for 12 months. | |
Other | Efficiency of the intervention | During the SMART trial, the investigators will record the number of daily brief contacts delivered to participants through WeChat and the application, text messages and phone calls. Of note, this outcome evaluates the implementation process of the intervention. | It will be evaluated after all patients in the SMART trial have been discharged for 12 months. | |
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. In the second implementation evaluation stage of the study, 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 SMART trial sample. | 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. | |
Other | The timeliness of the intervention | During the SMART trial, 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 after all patients in the SMART trial have been discharged for 12 months. | |
Other | The trajectory of 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's trajectory from baseline to three months after discharge will be recorded and compared. | It will be evaluated at three months after discharge. | |
Other | The trajectory of patients' perceived stigma from base line to 12 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's trajectory from baseline to 12 months after discharge will be recorded and compared. | It will be evaluated at 12 months after discharge. | |
Other | The trajectory of 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's trajectory from baseline to three months after discharge will be recorded and compared. | It will be evaluated at three months after discharge. | |
Other | The trajectory of patients' self-efficacy from baseline to 12 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's trajectory from baseline to 12 months after discharge will be recorded and compared. | It will be evaluated at 12 months after discharge. | |
Other | The change of 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 self-discontinued 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's trajectory from baseline to three months after discharge will be recorded and compared. | It will be evaluated at three months after discharge. | |
Other | The change of patients' compliance to treatment baseline to 12 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. 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's trajectory from baseline to 12 months after discharge will be recorded and compared. | It will be evaluated at 12 months after discharge. | |
Other | Attitudes towards the sustainability 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. In the second implementation evaluation stage of the study, focus group interviews will be conducted with the CBPR team understand the community's attitudes towards the sustainability 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 SMART trial sample. | 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. | |
Primary | 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. | |
Primary | 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 | The trajectory of social connectedness from baseline to 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's trajectory from baseline to three months after discharge will be recorded and compared. | It will be evaluated at three months after discharge. | |
Secondary | The trajectory of social connectedness from baseline to 12 months 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's trajectory from baseline to 12 months after discharge will be recorded and compared. | It will be evaluated at 12 months after discharge. | |
Secondary | The trajectory of social support from baseline to 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's trajectory from baseline to three months after discharge will be recorded and compared. | It will be evaluated at one month after discharge. | |
Secondary | The trajectory of social support from baseline to 12 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's trajectory from baseline to 12 months after discharge will be recorded and compared. | It will be evaluated at 12 months after discharge. | |
Secondary | The trajectory of suicide ideation from three months after discharge 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 three months after discharge to 12 months after discharge will be recorded and compared. | It will be evaluated at 12 months after discharge. |
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