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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04495543
• Other study ID #: BSL-01
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: March 24, 2023

Study information

• Verified date: November 2023
• Source: Unity Health Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 24, 2023
• Est. primary completion date: March 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Mental Health Issue
• Suicidal Ideation
• Suicide

Intervention

Behavioral:
• Brief Skills for Safer Living
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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant feedback on their experiences with specific aspects of the Brief-SfSL intervention	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.	3 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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