Living With Hope: A Preliminary Investigation of a Skills Class

Living With Hope: A Preliminary Investigation of a Novel, CBT-Based Psychoeducational Skills Class for Individuals With a Recent Suicide Attempt

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Suicidal Ideation; Suicide, Attempted; Suicide
• Intervention / Treatment: Behavioral: Living with Hope

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.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0Y1
      • Crisis Response Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 -

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants; Adults who have made a suicide attempt in the past 3 months who have been referred to, and enrolled in, the Living with Hope class.	Behavioral: Living with Hope; 12-week, CBT-based, psychoeducational skills class

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in scores on the Beck Scale for Suicide Ideation	21 item self-report measure of the severity of past-week suicidal ideation	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
Change in scores on the Columbia-Suicide Severity Rating Scale	Clinician-administered interview schedule designed to measure the timing and frequency of suicidal thoughts and behaviors	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
Suicide attempts	Presence of a suicide attempt during the study or over the follow-up period, as assessed by the Columbia-Suicide Severity Rating Scale	Through the duration of treatment and over follow-up period (approximately 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in scores on The Beck Hopelessness Scale	20-item self-report measure of past-week hopelessness and negative beliefs about the future	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
Change in scores on the Patient Health Questionnaire-9	9-item self-report measure of depressive symptom severity over the past two-weeks	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
Change in scores on the Difficulties in Emotion Regulation Scale	36-item measure of current emotional dysregulation difficulties	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
Change in scores on the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form	16-item self-report measure of current quality of life	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
Safety Item	One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings	Week 1 of Living with Hope class session
Safety Item	One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings	Week 2 of Living with Hope class session
Safety Item	One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings	Week 3 of Living with Hope class session
Safety Item	One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings	Week 4 of Living with Hope class session
Safety Item	One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings	Week 5 of Living with Hope class session
Safety Item	One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings	Week 6 of Living with Hope class session
Safety Item	One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings	Week 7 of Living with Hope class session
Safety Item	One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings	Week 8 of Living with Hope class session
Safety Item	One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings	Week 9 of Living with Hope class session
Safety Item	One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings	Week 10 of Living with Hope class session
Safety Item	One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings	Week 11 of Living with Hope class session
Safety Item	One item assessing the degree that the Living with Hope class session increased a participant's suicidal feelings	Week 12 of Living with Hope class session

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Health Sciences Centre Foundation, Manitoba
• Investigators: Principal Investigator: Christine A Henriksen, PhD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Estimated): August 30, 2023
• Study Completion (Estimated): February 28, 2024

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Suicide; Intervention; Suicidal Ideation; Pilot; Suicide Attempt
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Suicide, Attempted
• Other Study ID Numbers: H2019:292

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The research team has not determined whether de-identified individual participant data will be made available to other researchers after the completion of this study, as it is unclear whether our institution has a separate ethical approval process for this and what the requirements for this would be, if so. Additionally, it is unclear whether there is established infrastructure to ensure data are securely transferred to any potentially interested researcher to protect participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No