Suicidal IdeationNCT04495543
Mitigating Suicide Risk With Single Session 'Brief Skills for Safer Living'
A study testing Brief Skills for Safer Living in people with Suicidal Ideation and Suicide, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Mental health concerns have been on the rise since the onset of the COVID-19 pandemic. The pandemic has worsened risk factors for suicide, including job loss, anxiety, depression, and loneliness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation, Suicide, Mental Health Issue
- What is being tested?
- Brief Skills for Safer Living
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2020to 24 Mar 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Experiencing suicidal ideation in the past week (Beck Suicide Scale>10)
- Ability to undergo psychotherapy in English
- Access to a computer with a camera or a mobile phone with a camera
- Access to internet
- Access to an emergency contact and hospital within commuting distance
Show all 9Show fewer
- Not receiving other psychotherapy concurrently
- Willing to have the session recorded to review therapy fidelity
- Follow-up visits with a psychiatrist or family doctor where a psychotherapeutic modality (e.g. DBT, psychodynamic therapy, etc.) is not being used are allowable.
Who cannot join
- The presence of cognitive impairment that would limit consent or understanding of Brief-SfSL
- The presence of active psychosis
- Current substance use disorder
- Unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mitigating Suicide Risk During the COVID-19 Pandemic Via Telehealth Using an Intensive Single Session of "Brief Skills for Safer Living"
Mental health concerns have been on the rise since the onset of the COVID-19 pandemic. The pandemic has worsened risk factors for suicide, including job loss, anxiety, depression, and loneliness. Timely and easy access to mental health services is a dire need, and this study will test the efficacy and feasibility of a brief clinical intervention, Brief Skills for Safer Living (Brief-SfSL), at reducing suicide risk. The goal of this study is to investigate whether Brief-SfSL, delivered online, is a suitable, acceptable and effective method for reducing suicide risk and providing timely mental health services. The results from this study will provide vital insight into effective interventions for suicide risk that are accessible and can be widely distributed.
Read the detailed description
This study will test a brief online clinical intervention targeting suicide risk that will be delivered widely, remotely, rapidly and with minimal load on the healthcare system in Canada. The "Skills for Safer Living" (SfSL) intervention, a transdiagnostic 20-week group therapy intervention designed to teach concepts, skills and coping strategies through modules targeting common areas of deficits (Personal Safety, Emotional Literacy, Interpersonal Relationships and Problem-Solving), will be adapted into a single session "Brief-SfSL" that can be delivered in an online format. The proposed study will test the effectiveness of Brief-SfSL on reducing suicide risk, as measured by reductions in suicidal ideation after 3 months, and will provide evidence for a scalable intervention that can broadly reach urban and rural communities. Lack of suicide intervention services is an immense unmet need that is especially pronounced during this pandemic and is associated with increased burden on individuals and on the healthcare system. Considering the long wait times to access consistent psychiatric services, this proposed intervention is an essential step in providing evidence-based accessible suicide risk services during and even beyond the pandemic.
- Conditions
- Suicidal Ideation, Suicide, Mental Health Issue, Depression
- Being tested
- Brief Skills for Safer Living
- Keywords
- Suicide, Suicide Prevention, Suicide Risk, Suicidal Ideation, Psychotherapy, COVID-19, Depression
- Medical subject headings
- Suicidal Ideation, Suicide, Depression, Suicide Prevention, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Skills for Safer LivingBehavioural
Also called Brief-SfSL
Brief-SfSL is a single-session individual therapy adaptation of the core goals/principles of the 20-week SfSL group therapy. Brief-SfSL incorporates the SfSL guiding principles of emphasizing safety, attending to the therapeutic relationship, recognizing the participant as the expert in their own experience, taking a trauma-informed approach, working with emotions while recognizing the role of alexithymia, and incorporating solution-focused concepts. The goal is to increase a person's understanding and capacity to engage in what would enable them to keep safe, even if thoughts of suicide are present. The intervention procedure is dynamic, but includes 4 core tasks: 1) understanding the individual's suicidal experience, 2) skills building, 3) developing a safety plan, and 4) identifying obstacles to enacting or engaging with the safety plan.
| Study group | Role | What they receive |
|---|---|---|
| Brief-Skills for Safer Living (Brief-SfSL) | Experimental | Participants with current suicidal ideation (Beck Suicide Scale >10) will undergo Brief-SfSLtherapy Receives: Behavioral: Brief Skills for Safer Living |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in suicidal ideation using Beck Scale for Suicide Ideation
Beck Scale for Suicide Ideation is a 21-item self-report scale that quantifies suicidal ideation. Items are scored 0 to 2 and yield a total score ranging from 0 to 38. Higher scores reflect greater severity of suicidal ideation.
Measured: From baseline to 3 months; also administered at screening, 1 week and 1 month
Secondary outcomes (7)
Change in depression symptoms using the Quick Inventory of Depressive Symptoms self-report scale (QIDS-SR)
The QIDS-SR is a 16-item validated self-report depression scale. Total scores range from 0 (none) to 27 (very severe).
Measured: From baseline to 3 months; also administered at 1 week and 1 month
Change in anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7)
The GAD-7 is a brief 7-item self-report scale measuring anxiety symptoms. Total scores range from 0 to 21, with higher scores reflecting more severe anxiety.
Measured: From baseline to 3 months; also administered at 1 week and 1 month
Change in Acquired Capability of Suicide Scale (ACSS)
The ACSS is a 20-item self-report instrument to assess the construct of acquired capability. Total scores range from 0 to 80, with higher scores reflecting greater acquired capability.
Measured: From baseline to 3 months; also administered at 1 week and 1 month
Change in Interpersonal Needs Questionnaire score
The Interpersonal Needs Questionnaire is a 15-item self-report scale assessing connectedness to others and burdensomeness. Items are rated 1 to 7, with total scores ranging from 15 to 105. Higher scores reflect worse outcomes.
Measured: From baseline to 3 months; also administered at 1 week and 1 month
Change in Dimensional Anhedonia Rating Scale (DARS) score
The DARS is a 26-item self-report scale measuring anhedonia across four domains. Items are scored on a 5-point Likert scale with lower total scores reflecting more severe anhedonia.
Measured: From baseline to 3 months; also administered at 1 week and 1 month
Change in Sheehan Disability Scale (SDS) score
The SDS is a brief 3-item self-report scale that probes work/school, social, and family/home functioning. Each item is scored from 0 to 10. Total scores range from 0 (unimpaired) to 30 (highly impaired).
Measured: From baseline to 3 months; also administered at 1 month
Change in Treatment Utilization
Use of healthcare services will be assessed through four questions enquiring about the frequency and description of health care professional visits, use of mental health services, hospital admissions, and emergency room visits in the preceding specified time frame (1-3 months).
Measured: From screening to 3 months; also administered at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start1 Dec 2020
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 3 month, within subjects longitudinal study, with each participant receiving an intensive, single session of the 'Brief Skills for Safer Living' intervention designed to mitigate suicide risk. All participants recruited will have experienced suicidal ideation within the past week at time of enrolment.
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sakina Rizvi, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495543
- Sponsor's protocol ID
- BSL-01
- Status last verified
- Nov 2023
- First submitted
- 23 Jul 2020
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating Suicide Risk During the COVID-19 Pandemic Via Telehealth Using an Intensive Single Session of "Brief Skills for Safer Living"
- ClinicalTrials.gov ID
- NCT04495543
- Acronym / sponsor ID
- BSL-01
- Conditions
- Suicidal Ideation, Suicide, Mental Health Issue, Depression
- Keywords
- Suicide, Suicide Prevention, Suicide Risk, Suicidal Ideation, Psychotherapy, COVID-19, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 3 Aug 2020 (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.
Mental health concerns have been on the rise since the onset of the COVID-19 pandemic. The pandemic has worsened risk factors for suicide, including job loss, anxiety, depression, and loneliness. Timely and easy access to mental health services is a dire need, and this study will test the efficacy and feasibility of a brief clinical intervention, Brief Skills for Safer Living (Brief-SfSL), at reducing suicide risk. The goal of this study is to investigate whether Brief-SfSL, delivered online, is a suitable, acceptable and effective method for reducing suicide risk and providing timely mental health services. The results from this study will provide vital insight into effective interventions for suicide risk that are accessible and can be widely distributed.
Detailed description
This study will test a brief online clinical intervention targeting suicide risk that will be delivered widely, remotely, rapidly and with minimal load on the healthcare system in Canada. The "Skills for Safer Living" (SfSL) intervention, a transdiagnostic 20-week group therapy intervention designed to teach concepts, skills and coping strategies through modules targeting common areas of deficits (Personal Safety, Emotional Literacy, Interpersonal Relationships and Problem-Solving), will be adapted into a single session "Brief-SfSL" that can be delivered in an online format. The proposed study will test the effectiveness of Brief-SfSL on reducing suicide risk, as measured by reductions in suicidal ideation after 3 months, and will provide evidence for a scalable intervention that can broadly reach urban and rural communities. Lack of suicide intervention services is an immense unmet need that is especially pronounced during this pandemic and is associated with increased burden on individuals and on the healthcare system. Considering the long wait times to access consistent psychiatric services, this proposed intervention is an essential step in providing evidence-based accessible suicide risk services during and even beyond the pandemic.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 3 month, within subjects longitudinal study, with each participant receiving an intensive, single session of the 'Brief Skills for Safer Living' intervention designed to mitigate suicide risk. All participants recruited will have experienced suicidal ideation within the past week at time of enrolment.
| Arm | Type | Receives |
|---|---|---|
| Brief-Skills for Safer Living (Brief-SfSL) | Experimental | Behavioral: Brief Skills for Safer LivingParticipants with current suicidal ideation (Beck Suicide Scale >10) will undergo Brief-SfSLtherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years or older
- Experiencing suicidal ideation in the past week (Beck Suicide Scale>10)
- Ability to undergo psychotherapy in English
- Access to a computer with a camera or a mobile phone with a camera
- Access to internet
Key exclusion criteria (4 listed)
- The presence of cognitive impairment that would limit consent or understanding of Brief-SfSL
- The presence of active psychosis
- Current substance use disorder
- Unwilling or unable to provide informed consent
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 Skills for Safer LivingAlso: Brief-SfSLBrief-SfSL is a single-session individual therapy adaptation of the core goals/principles of the 20-week SfSL group therapy. Brief-SfSL incorporates the SfSL guiding principles of emphasizing safety, attending to the therapeutic relationship, recognizing the participant as the expert in their own experience, taking a trauma-informed approach, working with emotions while recognizing the role of alexithymia, and incorporating solution-focused concepts. The goal is to increase a person's understanding and capacity to engage in what would enable them to keep safe, even if thoughts of suicide are present. The intervention procedure is dynamic, but includes 4 core tasks: 1) understanding the individual's suicidal experience, 2) skills building, 3) developing a safety plan, and 4) identifying obstacles to enacting or engaging with the safety plan. | Behavioural | Brief-Skills for Safer Living (Brief-SfSL) |
Primary outcome
Change in suicidal ideation using Beck Scale for Suicide Ideation
Time frame: From baseline to 3 months; also administered at screening, 1 week and 1 month
Beck Scale for Suicide Ideation is a 21-item self-report scale that quantifies suicidal ideation. Items are scored 0 to 2 and yield a total score ranging from 0 to 38. Higher scores reflect greater severity of suicidal ideation.
7 secondary outcomes
Change in depression symptoms using the Quick Inventory of Depressive Symptoms self-report scale (QIDS-SR)
Time frame: From baseline to 3 months; also administered at 1 week and 1 month
Change in anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7)
Time frame: From baseline to 3 months; also administered at 1 week and 1 month
Change in Acquired Capability of Suicide Scale (ACSS)
Time frame: From baseline to 3 months; also administered at 1 week and 1 month
Change in Interpersonal Needs Questionnaire score
Time frame: From baseline to 3 months; also administered at 1 week and 1 month
Change in Dimensional Anhedonia Rating Scale (DARS) score
Time frame: From baseline to 3 months; also administered at 1 week and 1 month
Change in Sheehan Disability Scale (SDS) score
Time frame: From baseline to 3 months; also administered at 1 month
Change in Treatment Utilization
Time frame: From screening to 3 months; also administered at 1 month
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 9 Nov 2023.
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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.
Sakina Rizvi, PhD principal investigator
Unity Health Toronto
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 Skills for Safer Living in people with Suicidal Ideation and Suicide, run by Unity Health Toronto 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 9 inclusion and 4 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 9 Nov 2023. 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?
Change in suicidal ideation using Beck Scale for Suicide Ideation (time frame: From baseline to 3 months; also administered at screening, 1 week and 1 month). 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 9 Nov 2023.