Crisis Response Centre
Winnipeg, Manitoba, R3E 0Y1, Canada
NCT Number: NCT04140149
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.
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Notify Me18 year and older
All sexes
Observational
Winnipeg, Manitoba, R3E 0Y1, Canada
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 (e.g., 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 n=60). 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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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Exclusion criteria
12-week, CBT-based, psychoeducational skills class
Time frame: Change from baseline to mid-treatment (approximately 7 weeks), to post-treatment (approximately 14 weeks), to 1-month follow-up, and to 3-month follow-up
21 item self-report measure of the severity of past-week suicidal ideation
Time frame: Change from baseline to mid-treatment (approximately 7 weeks), to post-treatment (approximately 14 weeks), to 1-month follow-up, and to 3-month follow-up
Clinician-administered interview schedule designed to measure the timing and frequency of suicidal thoughts and behaviors
Time frame: Through the duration of treatment and over follow-up period (approximately 6 months)
Presence of a suicide attempt during the study or over the follow-up period, as assessed by the Columbia-Suicide Severity Rating Scale
Time frame: Change from baseline to mid-treatment (approximately 7 weeks), to post-treatment (approximately 14 weeks), to 1-month follow-up, and to 3-month follow-up
20-item self-report measure of past-week hopelessness and negative beliefs about the future
Time frame: Change from baseline to mid-treatment (approximately 7 weeks), to post-treatment (approximately 14 weeks), to 1-month follow-up, and to 3-month follow-up
9-item self-report measure of depressive symptom severity over the past two-weeks
Time frame: Change from baseline to mid-treatment (approximately 7 weeks), to post-treatment (approximately 14 weeks), to 1-month follow-up, and to 3-month follow-up
36-item measure of current emotional dysregulation difficulties
Time frame: Change from baseline to mid-treatment (approximately 7 weeks), to post-treatment (approximately 14 weeks), to 1-month follow-up, and to 3-month follow-up
16-item self-report measure of current quality of life
Time frame: Week 1 of Living with Hope class session
One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings
Time frame: Week 2 of Living with Hope class session
One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings
Time frame: Week 3 of Living with Hope class session
One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings
Time frame: Week 4 of Living with Hope class session
One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings
Time frame: Week 5 of Living with Hope class session
One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings
Time frame: Week 6 of Living with Hope class session
One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings
Time frame: Week 7 of Living with Hope class session
One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings
Time frame: Week 8 of Living with Hope class session
One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings
Time frame: Week 9 of Living with Hope class session
One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings
Time frame: Week 10 of Living with Hope class session
One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings
Time frame: Week 11 of Living with Hope class session
One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings
Time frame: Week 12 of Living with Hope class session
One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings
University of Manitoba
Other
Living With Hope: A Preliminary Investigation of a Novel, CBT-Based Psychoeducational Skills Class for Individuals With a Recent Suicide Attempt
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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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