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Clinical Trials/NCT04495543
NCT04495543
Completed
Not Applicable

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

Unity Health Toronto1 site in 1 country77 target enrollmentDecember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicidal Ideation
Sponsor
Unity Health Toronto
Enrollment
77
Locations
1
Primary Endpoint
Change in suicidal ideation using Beck Scale for Suicide Ideation
Status
Completed
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 1, 2020
End Date
March 24, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change in depression symptoms using the Quick Inventory of Depressive Symptoms self-report scale (QIDS-SR)(From baseline to 3 months; also administered at 1 week and 1 month)
  • Change in Acquired Capability of Suicide Scale (ACSS)(From baseline to 3 months; also administered at 1 week and 1 month)
  • Change in Dimensional Anhedonia Rating Scale (DARS) score(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)(From baseline to 3 months; also administered at 1 week and 1 month)
  • Change in Interpersonal Needs Questionnaire score(From baseline to 3 months; also administered at 1 week and 1 month)
  • Change in Treatment Utilization(From screening to 3 months; also administered at 1 month)
  • Change in Sheehan Disability Scale (SDS) score(From baseline to 3 months; also administered at 1 month)

Study Sites (1)

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