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

Study Overview
=================
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.

Official Title
-----------------
Mitigating Suicide Risk During the COVID-19 Pandemic Via Telehealth Using an Intensive Single Session of Brief Skills for Safer Living

Conditions
-----------------
Suicidal Ideation, Suicide, Mental Health Issue, Depression

Intervention / Treatment
-----------------
* Behavioral: Brief Skills for Safer Living


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief-Skills for Safer Living (Brief-SfSL)<br>Participants with current suicidal ideation (Beck Suicide Scale >10) will undergo Brief-SfSLtherapy | Behavioral: Brief Skills for Safer Living<br>* 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.<br>* Other names: Brief-SfSL;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From baseline to 3 months; also administered at screening, 1 week and 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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. | 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. | 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. | 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). | 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). | From screening to 3 months; also administered at 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Suicide, Suicide Prevention, Suicide Risk, Suicidal Ideation, Psychotherapy, COVID-19, Depression