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Completed

NCT Number: NCT04495543

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

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.

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Key information

Conditions

Suicidal Ideation Behavior Behavioral Symptoms COVID-19 Coronaviridae Infections Coronavirus Infections Depression Infections Lung Diseases Mental Health Issue Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Self-Injurious Behavior Suicide Suicide Prevention Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1M8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Brief-SfSL

Primary outcomes

  1. 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

  1. Change in depression symptoms using the Quick Inventory of Depressive Symptoms self-report scale (QIDS-SR)

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

    The QIDS-SR is a 16-item validated self-report depression scale. Total scores range from 0 (none) to 27 (very severe).

  2. Change in anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7)

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

    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.

  3. Change in Acquired Capability of Suicide Scale (ACSS)

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

    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.

  4. Change in Interpersonal Needs Questionnaire score

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

    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.

  5. Change in Dimensional Anhedonia Rating Scale (DARS) score

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

    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.

  6. Change in Sheehan Disability Scale (SDS) score

    Time frame: From baseline to 3 months; also administered at 1 month

    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).

  7. Change in Treatment Utilization

    Time frame: From screening to 3 months; also administered at 1 month

    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).

Other outcomes

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

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2020
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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