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

NCT04495543 | Completed

• 1 other identifier: BSL-01
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation; Suicide; Mental Health Issue; Depression

Keywords

Suicide; Suicide Prevention; Suicide Risk; Suicidal Ideation; Psychotherapy; COVID-19; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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 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 Acquired Capability of Suicide Scale (ACSS)

  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 Dimensional Anhedonia Rating Scale (DARS) score

  From baseline to 3 months; also administered at 1 week and 1 month

Other Outcomes (1)

• Participant feedback on their experiences with specific aspects of the Brief-SfSL intervention

  3 months

Study Arms (1)

Brief-Skills for Safer Living (Brief-SfSL)

EXPERIMENTAL

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

Behavioral: Brief Skills for Safer Living

Interventions

Brief Skills for Safer Living BEHAVIORAL

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.

Also known as: Brief-SfSL

Brief-Skills for Safer Living (Brief-SfSL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1M8, Canada

Location

MeSH Terms

Conditions

Suicidal Ideation; Suicide; Depression; Suicide Prevention; COVID-19

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sakina Rizvi, PhD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: August 3, 2020
• Study Start: December 1, 2020
• Primary Completion: March 24, 2023
• Study Completion: March 24, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

CA (1)