Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571916
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Brief Skills for Safer Living Brief-SfSL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigating the Efficacy of a Novel Therapy for Suicide Risk in Adults A Randomized Controlled Trial of an Intensive Single Session of Brief Skills for Safer Living
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this project is to assess the efficacy of Brief-Skills for Safer Living Brief-SfSL in a randomized control trial The investigators will be testing 150 participants Canada-wide half of which will be randomized to receive Brief-SfSL B-TAU and the other half will be randomized to receive Brief-SfSL after a 3 month waitlist WL-TAU The main questions this study seeks to answer are
Is B-TAU more efficacious than WL-TAU for reducing suicidal thoughts at 3 months
Is B-TAU more efficacious than WL-TAU at 3 months for reducing depression severity anxiety as well as improving quality of life
Are adverse events equivalent between B-TAU and WL-TAU at 3 months
Is B-TAU more efficacious than WL-TAU for reducing suicidal thoughts at 3 months
Is B-TAU more efficacious than WL-TAU at 3 months for reducing depression severity anxiety as well as improving quality of life
Are adverse events equivalent between B-TAU and WL-TAU at 3 months
Detailed Description:
There are 2 million people in Canada at risk of death from suicide and suicide rates have not changed in the last 10 years The COVID-19 pandemic also increased suicide risk and intensified a pre-existing lack of access to vital mental health services with wait lists up to 1 year To address this issue the investigators developed Brief Skills for Safer Living Brief-SfSL a single-session individual psychotherapy intervention with the potential to make it easier to access care and shorten the time for people to access intervention Derived from the proven success of the original SfSL 20-week group therapy Brief-SfSL goes beyond conventional approaches by helping individuals understand their suicidal thoughts build skills to manage these thoughts and stay safe during crises The strong results of the investigators single-arm trial of virtually-delivered Brief-SfSL in 77 adults with suicidal ideation across Canada show that Brief-SfSL is a feasible acceptable and safe intervention that has the potential to reduce suicide risk To prove that it is the investigators need to expand their study to include a treatment as usual TAU comparison group in a randomized controlled trial RCT The investigators will conduct an RCT that includes 2 groups 75 participants who will receive TAU plus Brief-SfSL and 75 who will receive TAU and be on a 3-month wait-list for Brief-SfSL The aim is to compare the efficacy of Brief-SfSL vs TAU on suicidal ideation and proxies for suicide risk eg depression anxiety over 3 months If the results confirm the efficacy of Brief-SfSL over TAU this will provide definitive data to support the broad implementation of Brief-SfSL in hospitals and community mental health agencies across Canada Study results will also be used to plan trials to assess the long-term impact of Brief-SfSL on suicide risk healthcare system utilization and health economics Through this research the investigators aim to save lives and also shift the paradigm of mental health intervention on a national scale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None