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Mitigating Suicide Risk With Single Session 'Brief Skills for Safer Living'

Primary Purpose

Suicidal Ideation, Suicide, Mental Health Issue

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Brief Skills for Safer Living
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicidal Ideation focused on measuring Suicide, Suicide Prevention, Suicide Risk, Suicidal Ideation, Psychotherapy, COVID-19, Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • St. Michael's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brief-Skills for Safer Living (Brief-SfSL)

Arm Description

Participants with current suicidal ideation (Beck Suicide Scale >10) will undergo Brief-SfSLtherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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.
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.
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).
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).

Full Information

First Posted
July 23, 2020
Last Updated
November 4, 2022
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT04495543
Brief Title
Mitigating Suicide Risk With Single Session 'Brief Skills for Safer Living'
Official Title
Mitigating Suicide Risk During the COVID-19 Pandemic Via Telehealth Using an Intensive Single Session of "Brief Skills for Safer Living"
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Unity Health Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation, Suicide, Mental Health Issue, Depression
Keywords
Suicide, Suicide Prevention, Suicide Risk, Suicidal Ideation, Psychotherapy, COVID-19, Depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brief-Skills for Safer Living (Brief-SfSL)
Arm Type
Experimental
Arm Description
Participants with current suicidal ideation (Beck Suicide Scale >10) will undergo Brief-SfSLtherapy
Intervention Type
Behavioral
Intervention Name(s)
Brief Skills for Safer Living
Other Intervention Name(s)
Brief-SfSL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in suicidal ideation using Beck Scale for Suicide Ideation
Description
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.
Time Frame
From baseline to 3 months; also administered at screening, 1 week and 1 month
Secondary Outcome Measure Information:
Title
Change in depression symptoms using the Quick Inventory of Depressive Symptoms self-report scale (QIDS-SR)
Description
The QIDS-SR is a 16-item validated self-report depression scale. Total scores range from 0 (none) to 27 (very severe).
Time Frame
From baseline to 3 months; also administered at 1 week and 1 month
Title
Change in anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7)
Description
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.
Time Frame
From baseline to 3 months; also administered at 1 week and 1 month
Title
Change in Acquired Capability of Suicide Scale (ACSS)
Description
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.
Time Frame
From baseline to 3 months; also administered at 1 week and 1 month
Title
Change in Interpersonal Needs Questionnaire score
Description
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.
Time Frame
From baseline to 3 months; also administered at 1 week and 1 month
Title
Change in Dimensional Anhedonia Rating Scale (DARS) score
Description
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.
Time Frame
From baseline to 3 months; also administered at 1 week and 1 month
Title
Change in Sheehan Disability Scale (SDS) score
Description
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).
Time Frame
From baseline to 3 months; also administered at 1 month
Title
Change in Treatment Utilization
Description
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).
Time Frame
From screening to 3 months; also administered at 1 month
Other Pre-specified Outcome Measures:
Title
Participant feedback on their experiences with specific aspects of the Brief-SfSL intervention
Description
Feasibility and Acceptability survey and interview created in-house with questions designed to collect quantitative and qualitative feedback from participants with respect to the feasibility and acceptability of the Brief-SfSL intervention.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sakina Rizvi, PhD
Phone
416-864-6060
Ext
6489
Email
sakina.rizvi@unityhealth.to
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Morton, HBSc
Phone
416-864-6060
Ext
47844
Email
michael.morton@unityhealth.to
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sakina Rizvi, PhD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1M8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Morton, HBSc
Phone
416-864-6060
Ext
47844
Email
michael.morton@unityhealth.to
First Name & Middle Initial & Last Name & Degree
Sakina Rizvi, PhD
First Name & Middle Initial & Last Name & Degree
Sidney H Kennedy, MD
First Name & Middle Initial & Last Name & Degree
Yvonne Bergmans, PhD
First Name & Middle Initial & Last Name & Degree
Aleksandra Lalovic, PhD

12. IPD Sharing Statement

Learn more about this trial

Mitigating Suicide Risk With Single Session 'Brief Skills for Safer Living'

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