Clinical trial NCT04495543: Mitigating Suicide Risk With Single Session 'Brief Skills for Safer Living'
Official title: Mitigating Suicide Risk During the COVID-19 Pandemic Via Telehealth Using an Intensive Single Session of "Brief Skills for Safer Living"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Ideation
Suicide
Mental Health Issue
Depression
Keywords: Suicide
Suicide Prevention
Suicide Risk
Suicidal Ideation
Psychotherapy
COVID-19
Depression
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in suicidal ideation using Beck Scale for Suicide Ideation
timeFrame: From baseline to 3 months; also administered at screening, 1 week and 1 month
Secondary outcomes:
measure: Change in depression symptoms using the Quick Inventory of Depressive Symptoms self-report scale (QIDS-SR)
timeFrame: From baseline to 3 months; also administered at 1 week and 1 month
measure: Change in anxiety symptoms using the Generalized Anxiety Disorder 7-item scale (GAD-7)
timeFrame: From baseline to 3 months; also administered at 1 week and 1 month
measure: Change in Acquired Capability of Suicide Scale (ACSS)
timeFrame: From baseline to 3 months; also administered at 1 week and 1 month
measure: Change in Interpersonal Needs Questionnaire score
timeFrame: From baseline to 3 months; also administered at 1 week and 1 month
measure: Change in Dimensional Anhedonia Rating Scale (DARS) score
timeFrame: From baseline to 3 months; also administered at 1 week and 1 month
measure: Change in Sheehan Disability Scale (SDS) score
timeFrame: From baseline to 3 months; also administered at 1 month
measure: Change in Treatment Utilization
timeFrame: From screening to 3 months; also administered at 1 month
Other outcomes:
measure: Participant feedback on their experiences with specific aspects of the Brief-SfSL intervention
timeFrame: 3 months
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Sakina Rizvi, PhD
role: PRINCIPAL_INVESTIGATOR
References: