Suicidal BehaviorBICNCT03825354
Brief Intervention and Contact (BIC) Program
A study testing BIC 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. Suicide is a multi-faceted issue that is often comorbid with psychiatric illness and associated with diverse sociodemographic risk factors. 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?
- BIC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2019to 30 Sep 2021
- 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
- All patients with a previous suicide attempt or expressed any suicidal behaviour who are admitted to inpatient psychiatric wards will be asked to participate in this study, with no upper age limit, sex or gender restriction.
- No restrictions will be placed on the patients' diagnoses or comorbidities, although all diagnoses will be documented.
- Patients in inpatient units and receiving treatment for comorbid psychiatric illnesses and/or their suicidal behaviour as per usual care including medication, individual or group psychotherapies and other treatment modalities are eligible to participate in the study.
- All participants must be able to provide written informed consent and can be reached through phone calls and/or text messages or in-person visits to the hospital site.
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.
Canada1 site
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Ontario, L8N 3K7
About this study
Official title: Brief Intervention and Contact (BIC) Program to Manage Suicidal Behaviour: A Pilot Study
Suicide is a significant public health concern and causes approximately 1.5 % of all deaths in the general population in Canada. Suicide is a multi-faceted issue that is often comorbid with psychiatric illness and associated with diverse sociodemographic risk factors. Consequently, there are several domains of suicide risk management. The proposed intervention, the brief intervention, and contact (BIC) model will be tested for feasibility using a pilot pragmatic randomized trial.
Read the detailed description
Brief contact interventions are distinct from other treatments for suicide and suicidal behaviour, in that the goals include maintaining long-term contact with patients, and through this, provide opportunities for them to re-engage with mental health services when needed. Additionally, brief interventions are not required to be carried out by mental health professionals (i.e. psychiatrists, psychologists, social workers), and they are provided over a structured schedule over a prolonged period post discharge.
The brief intervention and contact (BIC) model followed in this study is based on the BIC model that was utilised by the WHO as part of the Multisite Intervention Study On Suicidal Behaviours (SUPRE-MISS). A sub-project of the SUPRE-MISS study involved the implementation of a brief intervention that included an hour-long information session about suicide and suicidal behaviour around the discharge period, and nine periods of follow up through an in-person visit or phone call to assess the patient's well-being and provide referrals to clinical services as needed. Following implementation, an analysis of the effectiveness of the BIC model in five different countries, Brazil, India, Sri Lanka, Islamic Republic of Iran, and China, outline its potential utility. Compared to patients in the control group, there was a reduction in suicide rates in patients who received the BIC intervention.
This is a pilot study to test the feasibility of implementing the BIC protocol in a large multisite trial. We will, however, provide the objective of the main study to provide an overview of the study and the intended outcomes in addition to the pilot study objectives as below.
Study question and hypothesis of the main study:
For patients with suicidal behaviour admitted to inpatient units of acute and tertiary hospitals, does the addition of a brief intervention and contact program decrease suicide re-attempts, reduce depressive symptoms, improve social connectivity, and reduce further ER visits, compared to treatment as usual after 18 months of follow-up? The pilot study will be for 6 months only. We hypothesize that brief intervention and contact is an effective intervention for reducing suicidal behaviour in patients who have attempted suicide.
The intervention:
Patients in the intervention group will receive the BIC intervention, alongside treatment as usual. BIC consists of a 1-hour information session about the epidemiology and presentation of suicide and suicidal behaviour at the time of discharge, along with follow-up with patients at 1, 2, 4, 6 weeks, and 3, 4, 5, and 6 months. The intention of the frequency of follow up is to increase the time between follow up visits as per the original protocol and eventually discontinue. Follow-up contact will involve assessing how patients feel and whether they need additional support. The WHO protocol that contains all questionnaires to be used for follow-up is attached to this protocol.
The control:
Patients in the control group will receive treatment as usual. Pilot Study Objectives
Primary objectives:
The main goal of pilot phase is to enhance the success of the full trial by testing the feasibility of conducting a randomized controlled trial to assess the effectiveness of a brief intervention and contact program for suicide delivered through a face to face, phone or text-based intervention in addition to treatment as usual to reduce suicide attempts, depressive symptoms and ER visits, and improve social connectivity.
The pilot primary objectives are therefore summarized after Thabane and colleagues (cite the ref here):
- Assess the feasibility of the study process in terms of recruitment, retention, number of follow-ups completed, and data completion
- Assess resources needed including the use of mobile phones for contacting patients, interview spaces for initial intake questionnaire and consent processes.
Pilot study secondary objectives
- Assess reduction in subsequent suicide attempts and completed suicides through access to medical records over 6 months post discharge
- Assess the change in depressive symptoms using the Beck Depression Inventory between and within the intervention and control groups
- Explore the change in sense of social connectivity and social support using the Bille-Brahe Social Support Questionnaire, the Sarason Social Support Questionnaire (short form), and two questions pertaining to the places and activities the patient engages in most often between and within the intervention and control groups
- Assess the reduction in ER visits between and within the intervention and control groups
- Conditions
- Suicidal Behavior
- Being tested
- BIC
- Keywords
- suicide, thoughts, attempts, death, brief intervention, contact
- Medical subject headings
- Suicide, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BICBehavioural
World Health Organization, WHO, Brief Intervention and Contact (BIC)
| Study group | Role | What they receive |
|---|---|---|
| Brief Intervention and contact (BIC) | 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: Behavioral: BIC |
| 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.
Recruitment rate
The percentage of potential participants agree to consent to the study
Measured: 6 months
Retention rate
The percentage of participants who completes the study
Measured: 6 months
Data completion rate
the percentage of participants who complete all study questionnaires and follow up contacts
Measured: 6 months
Secondary outcomes (1)
The number of suicidal behaviour events
The number of documented suicidal behaviour events including ideas, attempts and completion
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 posted31 Jan 2019
- Study start1 Apr 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- a randomized study with 1:1 parallel design
- Masking
- None (open label)
- Enrolment
- 61 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
- z Samaan, MD/PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03825354
- Sponsor's protocol ID
- Project Number: 5880
- Acronym
- BIC
- Status last verified
- Sep 2021
- First submitted
- 24 Jan 2019
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soni D, Panesar B, Dufort A, Guan L, Lee J, Waldern D, Hathaway S, Sanger N, Stacey S, Minuzzi L, Thabane L, Samaan Z. Recruitment rates, retention rates, and follow-up completion in a Brief Intervention and Contact trial for suicidal behavior: a feasibility study. Pilot Feasibility Stud. 2025 Apr 16;11(1):50. doi: 10.1186/s40814-025-01635-3.
PubMed 40241209
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention and Contact (BIC) Program to Manage Suicidal Behaviour: A Pilot Study
- ClinicalTrials.gov ID
- NCT03825354
- Acronym / sponsor ID
- BIC / Project Number: 5880
- Conditions
- Suicidal Behavior
- Keywords
- suicide, thoughts, attempts, death, brief intervention, contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 31 Jan 2019 (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. Suicide is a multi-faceted issue that is often comorbid with psychiatric illness and associated with diverse sociodemographic risk factors. Consequently, there are several domains of suicide risk management. The proposed intervention, the brief intervention, and contact (BIC) model will be tested for feasibility using a pilot pragmatic randomized trial.
Detailed description
Brief contact interventions are distinct from other treatments for suicide and suicidal behaviour, in that the goals include maintaining long-term contact with patients, and through this, provide opportunities for them to re-engage with mental health services when needed. Additionally, brief interventions are not required to be carried out by mental health professionals (i.e. psychiatrists, psychologists, social workers), and they are provided over a structured schedule over a prolonged period post discharge.
The brief intervention and contact (BIC) model followed in this study is based on the BIC model that was utilised by the WHO as part of the Multisite Intervention Study On Suicidal Behaviours (SUPRE-MISS). A sub-project of the SUPRE-MISS study involved the implementation of a brief intervention that included an hour-long information session about suicide and suicidal behaviour around the discharge period, and nine periods of follow up through an in-person visit or phone call to assess the patient's well-being and provide referrals to clinical services as needed. Following implementation, an analysis of the effectiveness of the BIC model in five different countries, Brazil, India, Sri Lanka, Islamic Republic of Iran, and China, outline its potential utility. Compared to patients in the control group, there was a reduction in suicide rates in patients who received the BIC intervention.
This is a pilot study to test the feasibility of implementing the BIC protocol in a large multisite trial. We will, however, provide the objective of the main study to provide an overview of the study and the intended outcomes in addition to the pilot study objectives as below.
Study question and hypothesis of the main study:
For patients with suicidal behaviour admitted to inpatient units of acute and tertiary hospitals, does the addition of a brief intervention and contact program decrease suicide re-attempts, reduce depressive symptoms, improve social connectivity, and reduce further ER visits, compared to treatment as usual after 18 months of follow-up? The pilot study will be for 6 months only. We hypothesize that brief intervention and contact is an effective intervention for reducing suicidal behaviour in patients who have attempted suicide.
The intervention:
Patients in the intervention group will receive the BIC intervention, alongside treatment as usual. BIC consists of a 1-hour information session about the epidemiology and presentation of suicide and suicidal behaviour at the time of discharge, along with follow-up with patients at 1, 2, 4, 6 weeks, and 3, 4, 5, and 6 months. The intention of the frequency of follow up is to increase the time between follow up visits as per the original protocol and eventually discontinue. Follow-up contact will involve assessing how patients feel and whether they need additional support. The WHO protocol that contains all questionnaires to be used for follow-up is attached to this protocol.
The control:
Patients in the control group will receive treatment as usual. Pilot Study Objectives
Primary objectives:
The main goal of pilot phase is to enhance the success of the full trial by testing the feasibility of conducting a randomized controlled trial to assess the effectiveness of a brief intervention and contact program for suicide delivered through a face to face, phone or text-based intervention in addition to treatment as usual to reduce suicide attempts, depressive symptoms and ER visits, and improve social connectivity.
The pilot primary objectives are therefore summarized after Thabane and colleagues (cite the ref here):
- Assess the feasibility of the study process in terms of recruitment, retention, number of follow-ups completed, and data completion
- Assess resources needed including the use of mobile phones for contacting patients, interview spaces for initial intake questionnaire and consent processes.
Pilot study secondary objectives
- Assess reduction in subsequent suicide attempts and completed suicides through access to medical records over 6 months post discharge
- Assess the change in depressive symptoms using the Beck Depression Inventory between and within the intervention and control groups
- Explore the change in sense of social connectivity and social support using the Bille-Brahe Social Support Questionnaire, the Sarason Social Support Questionnaire (short form), and two questions pertaining to the places and activities the patient engages in most often between and within the intervention and control groups
- Assess the reduction in ER visits between and within the intervention and control groups
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a randomized study with 1:1 parallel design
| Arm | Type | Receives |
|---|---|---|
| Brief Intervention and contact (BIC) | Experimental | Behavioral: BICBrief 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 (4 listed)
- All patients with a previous suicide attempt or expressed any suicidal behaviour who are admitted to inpatient psychiatric wards will be asked to participate in this study, with no upper age limit, sex or gender restriction.
- No restrictions will be placed on the patients' diagnoses or comorbidities, although all diagnoses will be documented.
- Patients in inpatient units and receiving treatment for comorbid psychiatric illnesses and/or their suicidal behaviour as per usual care including medication, individual or group psychotherapies and other treatment modalities are eligible to participate in the study.
- All participants must be able to provide written informed consent and can be reached through phone calls and/or text messages or in-person visits to the hospital site.
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 |
|---|---|---|
| BICWorld Health Organization, WHO, Brief Intervention and Contact (BIC) | Behavioural | Brief Intervention and contact (BIC) |
Primary outcome
Recruitment rate
Time frame: 6 months
The percentage of potential participants agree to consent to the study
Retention rate
Time frame: 6 months
The percentage of participants who completes the study
Data completion rate
Time frame: 6 months
the percentage of participants who complete all study questionnaires and follow up contacts
1 secondary outcome
The number of suicidal behaviour events
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 1 Feb 2022.
- Derived from this study: PubMed 40241209Soni D, Panesar B, Dufort A, Guan L, Lee J, Waldern D, Hathaway S, Sanger N, Stacey S, Minuzzi L, Thabane L, Samaan Z. Recruitment rates, retention rates, and follow-up completion in a Brief Intervention and Contact trial for suicidal behavior: a feasibility study. Pilot Feasibility Stud. 2025 Apr 16;11(1):50. doi: 10.1186/s40814-025-01635-3.
- 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.
z Samaan, MD/PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIC 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 4 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 1 Feb 2022. 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?
Recruitment rate (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?
On the ClinicalTrials.gov record for NCT03825354, which also lists 1 linked publication.
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 1 Feb 2022.