Suicidal BehaviorBICNCT05656781
Brief Intervention and Contact Program Main Trial
A study testing Brief Intervention and Contact (BIC) based on Word Health Organization (WHO) in people with Suicidal Behavior, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
Suicide is a significant public health concern and causes approximately 1.5% of all deaths in the general population in Canada. Research shows that for individuals with comorbid psychiatric illness and suicidal behaviour, the risk of further suicide attempts persists in the first two years post-discharge with the most… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Suicidal Behavior
- What is being tested?
- Brief Intervention and Contact (BIC) based on Word Health Organization (WHO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2022to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Admitted following a suicidal behaviour (suicide attempt or with suicidal ideation),
- At least 16 years of age, no restrictions on sex or gender
- Provide written, informed consent,
- Provide consent for research staff to have access to their electronic medical record (EMR),
- Provide consent for research staff to contact their primary care provider, outpatient and other healthcare providers care team, if necessary,
- Provide health card number and consent to share with Institute for Clinical Evaluative Sciences and link to Ontario health records to analyze and evaluate events such as admissions, death by suicide and usage of health care services (such as hospitalizations) in Ontario for the period covering the study time and 2 years post study completion. The 2 years post discharge will not be feasible to continue follow up for this trial and are reported to be a risk period in the literature. Therefore, we opted to leverage administrative health record data to enrich the study impact post study completion.
Who cannot join
- We will exclude patients who are unable to understand written and spoken English, as the research staff/clinicians delivering the intervention are limited to English-speaking populations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Innovative Brief Intervention Contact Program to Improve Healthcare Delivery for Suicidal Behaviour
Suicide is a significant public health concern and causes approximately 1.5% of all deaths in the general population in Canada. Research shows that for individuals with comorbid psychiatric illness and suicidal behaviour, the risk of further suicide attempts persists in the first two years post-discharge with the most vulnerable time being the period immediately post discharge.
Several studies have found that alongside usual treatment, follow-up with discharged patients through text messaging, phone calls and letters, contributes to a reduction in attempts and death by suicide, and instances of self-harm. In particular, brief contact interventions have shown positive impacts in reducing further completed suicide and suicidal behaviour in patients presenting to the emergency department following a suicide attempt.
The BIC model followed in this study is adapted from the WHO protocol that was utilised as part of the Multisite Intervention Study On Suicidal Behaviours (SUPRE-MISS).
Read the detailed description
Rationale The time post discharge from psychiatric hospital is a vulnerable time for suicide risk especially in patients with past suicidal behaviour as they are less likely to adhere to treatment post discharge with risk of being disengaged from healthcare services. The period after discharge therefore presents as a gap in patient care that needs to be addressed. Brief contact interventions are seen as a potential solution to this gap, thus providing justification for a trial such as this one, to test the effectiveness in a Canadian population.
Significance The rate of death by suicide has been static for past 20 years however suicidal behaviour is more dynamic with variable rates seen in those identified as high risk groups including those with a history of suicidal behaviour, males, youth, and the indigenous community. As such, there is a need to identify a feasible and accessible risk reduction strategy that can mitigate suicidal behaviour and empower individuals to leverage their social support system. We have completed a feasibility and pilot RCT study of BIC in one centre including 60 participants followed up for 6 months, which demonstrates the feasibility and justification of a main trial.
Innovation This is the first RCT that aims to impact and improve healthcare service delivery for patients with suicidal behaviour by testing a pragmatic intervention that can be easily translated into regular medical practice across institutions. This RCT builds on a pilot and feasibility trial, which has allowed for quality improvements that tailor the intervention to fit seamlessly into the discharge process. Specifically,
- A warm transfer has been incorporated into the study design to help the intervention resemble what it would look like if it were translated into regular medical practice. This warm transfer is also important as the highest loss to follow-up rates were seen in the first point of contact post-discharge. As such, a warm transfer will remind and inform the participant that they will be receiving support and contact post hospital discharge, impacting and improving healthcare service delivery.
- The Harbinger of Hope letter drafted by a person with lived experience will be given to the participants in the intervention arm, which directly impacts and improves healthcare service delivery by considering communication and peer supports outside of the regular care team. Participants will also be notified about the BeSafe smartphone and web application to access community support services specific to their needs (i.e. peer support, housing support, crisis services etc.), further emphasizing the focus on care outside of the most resources intense healthcare team.
- The incorporation of a unified text message and phone call system, through a major cellular service provider, combined with the mailing of resources to participants in the intervention arm, represent advanced communication and flexible contact strategies that improve patients' accessibility and delivery of healthcare. Currently using text messaging is not possible through usual hospital communications. Participants in the pilot trial identified text messages as a preferred and low-cost option for them.
- The incorporation of a qualitative component inquiring about participants experiences with healthcare services and the intervention will encourage participants to continue to engage in the contacts that are provided to them as the open-ended questions may be cathartic and provide a space for them to express their voices. The focus on the participants' voices once again profoundly impacts and improves healthcare service delivery by providing a platform for participants to engage. This this may also reduce disengagement and "no show" rates to appointments.
- The primary outcomes for this study include a reduction in suicidal behaviour (death by suicide, suicide attempts and thoughts) and healthcare utilization (ER visits \& readmissions), and an observation of the use of crisis service calls. The occurrence of these outcomes was lower in the intervention arm compared to the control arm when assessed in the pilot and feasibility trial (figure 1.0), which provides the justification for selecting these outcomes in a larger trial. Having these synonymous, clear, and measurable outcomes for the RCT will allow for the appropriate assessment of the effectiveness of BIC and will directly inform the translation of BIC into medical practice.
- Crisis services were alerted during two of the phone contacts in the pilot and feasibility trial due to risk of the participant engaging in a suicide attempt which was averted. This highlights the clinical significance of the pilot and feasibility trial and provides a strong basis to continue the evaluation of the BIC intervention to eventually incorporate it into regular medical practice. It also provides evidence for the improvement of healthcare delivery as these follow-ups with participants provide the opportunity for them to re-engage with mental health services when needed and provides them with more options than an emergency room visit.
- BIC was implemented by research staff in the pilot and feasibility trial. It will continue to be performed by research assistants that have received the appropriate safety, sensitivity, and informational trainings. This provides yet another key transferable aspect of the intervention into regular medical practice as there is no requirement for the intervention to be carried out by a mental health professional and can be administered by BIC trained personnel thus reducing the demands on services and intensive training required to deliver mental health care.
OBJECTIVES
- Our primary aims are A) to assess the effectiveness of BIC on reducing suicidal behaviour (i.e., death by suicide and suicide thoughts/ideas and attempts) and healthcare utilization (i.e., ER visits \& readmissions) post hospital discharge. B) assess the effects of BIC on crisis services used post discharge
- Our secondary aims are to use qualitative semi-structured interviews A) to understand participants' experiences with healthcare services post discharge, including descriptions of:
- Participants' satisfaction with healthcare services
- Participants' expectations of healthcare services
- Participants' perceived level of social connectivity and social support
- to understand participants' experiences with the BIC intervention, including descriptions of:
- Participants' satisfaction with the intervention
- Participants' perspective on the effectiveness of the intervention
- Changes participants want to make to the intervention
- Participants' experiences with the Harbinger of Hope letter given to them during the intervention
- Conditions
- Suicidal Behavior
- Being tested
- Brief Intervention and Contact (BIC) based on Word Health Organization (WHO)
- Keywords
- suicide, thoughts, attempts, brief intervention, contact
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Intervention and Contact (BIC) based on Word Health Organization (WHO)Other
Also called Brief Intervention and Contact (BIC)
Intervention based on: Clinical WHO - SUICIDE PREVENTION DOCUMENT MULTISITE INTERVENTION STUDY ON SUICIDAL BEHAVIOURS - SUPRE-MISS: PROTOCOL OF SUPRE-MISS. Brief Intervention and Contact with participants using follow up questions about mood or any suicide attempts.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm - Brief Intervention & Contact | Experimental | Brief education about suicidal behaviour and follow up contacts for 6 months in addition to treatment as usual. follow up will occur at the following time points post discharge: weeks 1, 2, 4, 6, 8, 12, 16 and 20. this will occur in addition to treatment as usual. Receives: Other: Brief Intervention and Contact (BIC) based on Word Health Organization (WHO) |
| Control | No intervention | Control will continue treatment as usual which is whatever the clinical team decides upon post discharge. Data will be collected on repeated suicidal behaviour through medical records with consent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal behaviour
Completed and attempted suicides will be measured using yes/no questions on a self-report questionnaire and will be corroborated using electronic medical record data
Measured: 6 months
Healthcare service utilization
This outcome will be measured using a questionnaire asking if any of the following supports were contacted:
psychiatric or general hospital, out-patient psychiatric service, policlinic service, day-care centre, community mental health care, private psychologist or psychiatrist, consultation service for alcohol and drug related problems, consultation service for relational and sexual problems, self-help group, telephone help line, relatives, friends
Measured: 6 months
Crisis services
This outcome will be measured using electronic medical record data indicating the number of times crisis phones calls were made and the number of emergency department visits occurred.
Measured: 6 months
Secondary outcomes (2)
Experiences with healthcare services post discharge
This outcome will be assessed qualitatively by inductively drawing themes from data collected using semi-structured interviews. Interview questions will include discussions about:
- Participants' satisfaction with healthcare services
- Participants' expectations of healthcare services
- Participants' perceived level of social connectivity and social support
Measured: 6 months
Experiences with the BIC intervention
Participants' satisfaction with the intervention will be assessed qualitatively by inductively drawing themes from data collected using semi-structured interviews. Interview questions will include discussions about
- Participants' perspective on the effectiveness of the intervention
- Changes participants want to make to the intervention
- Participants' experiences with the Harbinger of Hope letter given to them during the intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Aug 2022
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Samaan (Zena), St. Joseph's Healthcare Hamilton
- Investigators
- Zainab Samaan, MD/PhD, Principal investigator, McMaster Unversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656781
- Sponsor's protocol ID
- 14566 HAH-22-012
- Acronym
- BIC
- Status last verified
- May 2026
- First submitted
- 10 Nov 2022
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Brief Intervention Contact Program to Improve Healthcare Delivery for Suicidal Behaviour
- ClinicalTrials.gov ID
- NCT05656781
- Acronym / sponsor ID
- BIC / 14566 HAH-22-012
- Conditions
- Suicidal Behavior
- Keywords
- suicide, thoughts, attempts, brief intervention, contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Suicide is a significant public health concern and causes approximately 1.5% of all deaths in the general population in Canada. Research shows that for individuals with comorbid psychiatric illness and suicidal behaviour, the risk of further suicide attempts persists in the first two years post-discharge with the most vulnerable time being the period immediately post discharge.
Several studies have found that alongside usual treatment, follow-up with discharged patients through text messaging, phone calls and letters, contributes to a reduction in attempts and death by suicide, and instances of self-harm. In particular, brief contact interventions have shown positive impacts in reducing further completed suicide and suicidal behaviour in patients presenting to the emergency department following a suicide attempt.
The BIC model followed in this study is adapted from the WHO protocol that was utilised as part of the Multisite Intervention Study On Suicidal Behaviours (SUPRE-MISS).
Detailed description
Rationale The time post discharge from psychiatric hospital is a vulnerable time for suicide risk especially in patients with past suicidal behaviour as they are less likely to adhere to treatment post discharge with risk of being disengaged from healthcare services. The period after discharge therefore presents as a gap in patient care that needs to be addressed. Brief contact interventions are seen as a potential solution to this gap, thus providing justification for a trial such as this one, to test the effectiveness in a Canadian population.
Significance The rate of death by suicide has been static for past 20 years however suicidal behaviour is more dynamic with variable rates seen in those identified as high risk groups including those with a history of suicidal behaviour, males, youth, and the indigenous community. As such, there is a need to identify a feasible and accessible risk reduction strategy that can mitigate suicidal behaviour and empower individuals to leverage their social support system. We have completed a feasibility and pilot RCT study of BIC in one centre including 60 participants followed up for 6 months, which demonstrates the feasibility and justification of a main trial.
Innovation This is the first RCT that aims to impact and improve healthcare service delivery for patients with suicidal behaviour by testing a pragmatic intervention that can be easily translated into regular medical practice across institutions. This RCT builds on a pilot and feasibility trial, which has allowed for quality improvements that tailor the intervention to fit seamlessly into the discharge process. Specifically,
- A warm transfer has been incorporated into the study design to help the intervention resemble what it would look like if it were translated into regular medical practice. This warm transfer is also important as the highest loss to follow-up rates were seen in the first point of contact post-discharge. As such, a warm transfer will remind and inform the participant that they will be receiving support and contact post hospital discharge, impacting and improving healthcare service delivery.
- The Harbinger of Hope letter drafted by a person with lived experience will be given to the participants in the intervention arm, which directly impacts and improves healthcare service delivery by considering communication and peer supports outside of the regular care team. Participants will also be notified about the BeSafe smartphone and web application to access community support services specific to their needs (i.e. peer support, housing support, crisis services etc.), further emphasizing the focus on care outside of the most resources intense healthcare team.
- The incorporation of a unified text message and phone call system, through a major cellular service provider, combined with the mailing of resources to participants in the intervention arm, represent advanced communication and flexible contact strategies that improve patients' accessibility and delivery of healthcare. Currently using text messaging is not possible through usual hospital communications. Participants in the pilot trial identified text messages as a preferred and low-cost option for them.
- The incorporation of a qualitative component inquiring about participants experiences with healthcare services and the intervention will encourage participants to continue to engage in the contacts that are provided to them as the open-ended questions may be cathartic and provide a space for them to express their voices. The focus on the participants' voices once again profoundly impacts and improves healthcare service delivery by providing a platform for participants to engage. This this may also reduce disengagement and "no show" rates to appointments.
- The primary outcomes for this study include a reduction in suicidal behaviour (death by suicide, suicide attempts and thoughts) and healthcare utilization (ER visits \& readmissions), and an observation of the use of crisis service calls. The occurrence of these outcomes was lower in the intervention arm compared to the control arm when assessed in the pilot and feasibility trial (figure 1.0), which provides the justification for selecting these outcomes in a larger trial. Having these synonymous, clear, and measurable outcomes for the RCT will allow for the appropriate assessment of the effectiveness of BIC and will directly inform the translation of BIC into medical practice.
- Crisis services were alerted during two of the phone contacts in the pilot and feasibility trial due to risk of the participant engaging in a suicide attempt which was averted. This highlights the clinical significance of the pilot and feasibility trial and provides a strong basis to continue the evaluation of the BIC intervention to eventually incorporate it into regular medical practice. It also provides evidence for the improvement of healthcare delivery as these follow-ups with participants provide the opportunity for them to re-engage with mental health services when needed and provides them with more options than an emergency room visit.
- BIC was implemented by research staff in the pilot and feasibility trial. It will continue to be performed by research assistants that have received the appropriate safety, sensitivity, and informational trainings. This provides yet another key transferable aspect of the intervention into regular medical practice as there is no requirement for the intervention to be carried out by a mental health professional and can be administered by BIC trained personnel thus reducing the demands on services and intensive training required to deliver mental health care.
OBJECTIVES
- Our primary aims are A) to assess the effectiveness of BIC on reducing suicidal behaviour (i.e., death by suicide and suicide thoughts/ideas and attempts) and healthcare utilization (i.e., ER visits \& readmissions) post hospital discharge. B) assess the effects of BIC on crisis services used post discharge
- Our secondary aims are to use qualitative semi-structured interviews A) to understand participants' experiences with healthcare services post discharge, including descriptions of:
- Participants' satisfaction with healthcare services
- Participants' expectations of healthcare services
- Participants' perceived level of social connectivity and social support
- to understand participants' experiences with the BIC intervention, including descriptions of:
- Participants' satisfaction with the intervention
- Participants' perspective on the effectiveness of the intervention
- Changes participants want to make to the intervention
- Participants' experiences with the Harbinger of Hope letter given to them during the intervention
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm - Brief Intervention & Contact | Experimental | Other: Brief Intervention and Contact (BIC) based on Word Health Organization (WHO)Brief education about suicidal behaviour and follow up contacts for 6 months in addition to treatment as usual. follow up will occur at the following time points post discharge: weeks 1, 2, 4, 6, 8, 12, 16 and 20. this will occur in addition to treatment as usual. |
| Control | No intervention | –Control will continue treatment as usual which is whatever the clinical team decides upon post discharge. Data will be collected on repeated suicidal behaviour through medical records with consent. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Admitted following a suicidal behaviour (suicide attempt or with suicidal ideation),
- At least 16 years of age, no restrictions on sex or gender
- Provide written, informed consent,
- Provide consent for research staff to have access to their electronic medical record (EMR),
- Provide consent for research staff to contact their primary care provider, outpatient and other healthcare providers care team, if necessary,
Key exclusion criteria (1 listed)
- We will exclude patients who are unable to understand written and spoken English, as the research staff/clinicians delivering the intervention are limited to English-speaking populations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Intervention and Contact (BIC) based on Word Health Organization (WHO)Also: Brief Intervention and Contact (BIC)Intervention based on: Clinical WHO - SUICIDE PREVENTION DOCUMENT MULTISITE INTERVENTION STUDY ON SUICIDAL BEHAVIOURS - SUPRE-MISS: PROTOCOL OF SUPRE-MISS. Brief Intervention and Contact with participants using follow up questions about mood or any suicide attempts. | Other | Intervention Arm - Brief Intervention & Contact |
Primary outcome
Suicidal behaviour
Time frame: 6 months
Completed and attempted suicides will be measured using yes/no questions on a self-report questionnaire and will be corroborated using electronic medical record data
Healthcare service utilization
Time frame: 6 months
This outcome will be measured using a questionnaire asking if any of the following supports were contacted: psychiatric or general hospital, out-patient psychiatric service, policlinic service, day-care centre, community mental health care, private psychologist or psychiatrist, consultation service for alcohol and drug related problems, consultation service for relational and sexual problems, self-help group, telephone help line, relatives, friends
Crisis services
Time frame: 6 months
This outcome will be measured using electronic medical record data indicating the number of times crisis phones calls were made and the number of emergency department visits occurred.
2 secondary outcomes
Experiences with healthcare services post discharge
Time frame: 6 months
Experiences with the BIC intervention
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zainab Samaan, MD/PhD principal investigator
McMaster Unversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Intervention and Contact (BIC) based on Word Health Organization (WHO) in people with Suicidal Behavior, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidal behaviour (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.