Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03825354 |
| Other study ID # |
Project Number: 5880 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2019 |
| Est. completion date |
September 30, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
St. Joseph's Healthcare Hamilton |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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
