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CompletedNCT03825354BICUpdated Feb 1, 2022

Brief Intervention and Contact (BIC) Program

An interventional study of BIC in Suicidal Behavior, sponsored by St. Joseph's Healthcare Hamilton. Completed at 1 site in Canada. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2022-02-01.

Sponsored by St. Joseph's Healthcare Hamilton · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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. 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):

  1. Assess the feasibility of the study process in terms of recruitment, retention, number of follow-ups completed, and data completion
  2. 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

  1. Assess reduction in subsequent suicide attempts and completed suicides through access to medical records over 6 months post discharge
  2. Assess the change in depressive symptoms using the Beck Depression Inventory between and within the intervention and control groups
  3. 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
  4. Assess the reduction in ER visits between and within the intervention and control groups
02

Conditions studied

  • Suicidal Behavior

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Keywords

  • suicide
  • thoughts
  • attempts
  • death
  • brief intervention
  • contact
03

In context

Suicide

714 studies on the registry are indexed under Suicide; 184 are open to participants now.

This study's enrollment of 61 is below the median of 103 across 572 interventional studies indexed under Suicide.

Browse Suicide studies →

Lead sponsor

St. Joseph's Healthcare Hamilton is the lead sponsor of 143 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Brief Intervention and contact (BIC)

    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.

    Behavioral: BIC

  • No intervention
    control

    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.

Interventions

  • BehavioralBIC

    World Health Organization, WHO, Brief Intervention and Contact (BIC)

06

What researchers measure

Primary outcomes

  1. Recruitment rate

    The percentage of potential participants agree to consent to the study

    Time frame: 6 months

  2. Retention rate

    The percentage of participants who completes the study

    Time frame: 6 months

  3. Data completion rate

    the percentage of participants who complete all study questionnaires and follow up contacts

    Time frame: 6 months

Secondary outcomes

  1. The number of suicidal behaviour events

    The number of documented suicidal behaviour events including ideas, attempts and completion

    Time frame: 6 months

07

Study locations

1 site
  • St. Joseph's Healthcare Hamilton
    Hamilton, Ontario, Ontario L8N 3K7, Canada
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2019 to primary completion in Sep 2020, 17 months.

Of 353 non-industry interventional studies with no phase under Suicide, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 53. This study's 17 months is below that.

Counting every sponsor, half of 366 studies reached it within 30 months; a quarter within 14 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 24, 2019
First posted
Jan 31, 2019
StartActual
Apr 1, 2019
Primary completionActual
Sep 30, 2020
CompletionActual
Sep 30, 2021
Last update
Feb 1, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03825354
Responsible party
Zainab Samaan (Zena) (Associate Professor, St. Joseph's Healthcare Hamilton) — Principal investigator
First posted
Jan 31, 2019
Start date
Apr 1, 2019
Primary completion
Sep 30, 2020
Completion
Sep 30, 2021
Last update
Feb 1, 2022

Study contacts

z Samaan, MD/PhD
principal investigator · McMaster University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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