Ignite Creation Date:
2024-05-06 @ 1:50 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04140149
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2019-10-21
Brief Title:
Living With Hope A Preliminary Investigation of a Skills Class
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Living With Hope A Preliminary Investigation of a Novel CBT-Based Psychoeducational Skills Class for Individuals With a Recent Suicide Attempt
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine whether Living with Hope a novel 12-week coping skills class reduces suicidal thoughts and behaviors among individuals who have made a recent suicide attempt It is hypothesized that participants who complete the class will show significant improvements on measures of suicidal thoughts hopelessness and related mental health symptoms and these improvements will be maintained over time
Detailed Description:
As the 9th leading cause of death worldwide suicide is a major public health concern One of the groups as highest risk of death are those that have previously made a suicide attempt Effective treatment following a suicide attempt is imperative for reducing the risk of suicide with increasing evidence showing treatments that target suicide behavior are more effective at reducing risk over treatments that target related mental health difficulties eg depression However these treatments are resource intensive and are difficult to access in Manitoba and many individuals who have made a suicide attempt do not receive any mental health treatment In order to ensure timely access to treatment following a suicide attempt we have created a non-resource intensive psychoeducational skills class grounded in evidence-based suicide-specific treatment The primary aim of this study is to examine the safety and effectiveness of a novel 12-week cognitive behavior therapy-based virtual psychoeducational skills class Living with Hope in reducing suicidal thoughts and behaviors among adults who have made a recent suicide attempt and determine whether changes post-treatment are maintained at over time The secondary aim is to determine whether this intervention also results in improvements on related mental health outcomes and whether changes on these constructs mediate improvements on suicidal thoughts and behaviors
Adults ages 18 years and older who have been referred to the Living with Hope class over the 2 year study period will be invited to participate in the proposed study anticipated n60 Individuals are eligible for referral if they have made a suicide attempt in the past 3 months and are either seeking mental health crisis services Participants will complete standardized measures of primary suicidal thoughts and behaviors and secondary outcomes hopelessness depressive symptoms emotion regulation difficulties and quality of life at pre-treatment mid-way through the 12-week class post-treatment 1-month follow-up and 3-months follow-up Mixed-effects linear regression will determine whether there are significant differences on outcome measures at any of these five time-points as well as whether secondary outcomes mediate improvements on primary outcomes All research participation will be conducted through virtual means
The proposed study would be the first in Canada to examine the effectiveness of a low-cost targeted psychoeducational skills class in reducing suicidal thoughts and behaviors among individuals who have made a recent suicide attempt This will set the stage for future linkage with administrative data and randomized controlled trials aimed at determining whether the Living with Hope class results in reduced suicide attempts and deaths compared to treatment as usual If proven safe and effective through these rigorous evaluations the Living with Hope class could be widely disseminated in the public health system to provide care to a large number of Manitobans with the long-term goal of increasing access to timely targeted treatment and in turn reducing suicides in Manitoba
Adults ages 18 years and older who have been referred to the Living with Hope class over the 2 year study period will be invited to participate in the proposed study anticipated n60 Individuals are eligible for referral if they have made a suicide attempt in the past 3 months and are either seeking mental health crisis services Participants will complete standardized measures of primary suicidal thoughts and behaviors and secondary outcomes hopelessness depressive symptoms emotion regulation difficulties and quality of life at pre-treatment mid-way through the 12-week class post-treatment 1-month follow-up and 3-months follow-up Mixed-effects linear regression will determine whether there are significant differences on outcome measures at any of these five time-points as well as whether secondary outcomes mediate improvements on primary outcomes All research participation will be conducted through virtual means
The proposed study would be the first in Canada to examine the effectiveness of a low-cost targeted psychoeducational skills class in reducing suicidal thoughts and behaviors among individuals who have made a recent suicide attempt This will set the stage for future linkage with administrative data and randomized controlled trials aimed at determining whether the Living with Hope class results in reduced suicide attempts and deaths compared to treatment as usual If proven safe and effective through these rigorous evaluations the Living with Hope class could be widely disseminated in the public health system to provide care to a large number of Manitobans with the long-term goal of increasing access to timely targeted treatment and in turn reducing suicides in Manitoba
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None