Clinical trial NCT04140149: Living With Hope: A Preliminary Investigation of a Skills Class
Official title: Living With Hope: A Preliminary Investigation of a Novel, CBT-Based Psychoeducational Skills Class for Individuals With a Recent Suicide Attempt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicide
Suicide, Attempted
Suicidal Ideation
Keywords: Suicide
Suicide Attempt
Suicidal Ideation
Pilot
Intervention
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Health Sciences Centre Foundation, Manitoba
First posted: 2019-10-25
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults ages 18 years and older who have made a suicide attempt in the past 3 months and have sought mental health help through a local crisis response centre or emergency department.

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 (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.

Eligibility criteria: Inclusion Criteria:

1. Made a suicide attempt in the past 3 months
2. Sought mental health crisis services, and referred to the Living with Hope program

   -

Exclusion Criteria:

1. Not proficient in English
2. Exhibiting active psychotic symptoms
3. Significant cognitive impairment, are
4. Currently expressing anger or disappointment about the outcome of their attempt,
5. Recent history of violence or verbal aggression towards others, or are exhibiting other signs of behavior that would pose a threat to the safety or wellbeing of class participants 6. Primary substance use disorder -

Primary outcomes:
measure: Change in scores on the Beck Scale for Suicide Ideation
timeFrame: 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
measure: Change in scores on the Columbia-Suicide Severity Rating Scale
timeFrame: 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
measure: Suicide attempts
timeFrame: Through the duration of treatment and over follow-up period (approximately 6 months)
Secondary outcomes:
measure: Change in scores on The Beck Hopelessness Scale
timeFrame: 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
measure: Change in scores on the Patient Health Questionnaire-9
timeFrame: 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
measure: Change in scores on the Difficulties in Emotion Regulation Scale
timeFrame: 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
measure: Change in scores on the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form
timeFrame: 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
measure: Safety Item
timeFrame: Week 1 of Living with Hope class session
measure: Safety Item
timeFrame: Week 2 of Living with Hope class session
measure: Safety Item
timeFrame: Week 3 of Living with Hope class session
measure: Safety Item
timeFrame: Week 4 of Living with Hope class session
measure: Safety Item
timeFrame: Week 5 of Living with Hope class session
measure: Safety Item
timeFrame: Week 6 of Living with Hope class session
measure: Safety Item
timeFrame: Week 7 of Living with Hope class session
measure: Safety Item
timeFrame: Week 8 of Living with Hope class session
measure: Safety Item
timeFrame: Week 9 of Living with Hope class session
measure: Safety Item
timeFrame: Week 10 of Living with Hope class session
measure: Safety Item
timeFrame: Week 11 of Living with Hope class session
measure: Safety Item
timeFrame: Week 12 of Living with Hope class session
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Crisis Response Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Christine A Henriksen, PhD
role: PRINCIPAL_INVESTIGATOR
References: