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Completed

NCT Number: NCT04140149

Living With Hope: A Preliminary Investigation of a Skills Class

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Crisis Response Centre

Winnipeg, Manitoba, R3E 0Y1, Canada

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

-

Exclusion criteria

  • Not proficient in English
  • Exhibiting active psychotic symptoms
  • Significant cognitive impairment, are
  • Currently expressing anger or disappointment about the outcome of their attempt,
  • 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 -

Treatment and study plan

Living with Hope

Behavioral

12-week, CBT-based, psychoeducational skills class

Primary outcomes

  1. Change in scores on the Beck Scale for Suicide 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

    21 item self-report measure of the severity of past-week suicidal ideation

  2. Change in scores on 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

    Clinician-administered interview schedule designed to measure the timing and frequency of suicidal thoughts and behaviors

  3. Suicide attempts

    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

Secondary outcomes

  1. Change in scores on The Beck Hopelessness 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

  2. Change in scores on the Patient Health Questionnaire-9

    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

  3. Change in scores on the Difficulties in Emotion Regulation 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

    36-item measure of current emotional dysregulation difficulties

  4. Change in scores on the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form

    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

  5. Safety Item

    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

  6. Safety Item

    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

  7. Safety Item

    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

  8. Safety Item

    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

  9. Safety Item

    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

  10. Safety Item

    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

  11. Safety Item

    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

  12. Safety Item

    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

  13. Safety Item

    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

  14. Safety Item

    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

  15. Safety Item

    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

  16. Safety Item

    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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Health Sciences Centre Foundation, Manitoba

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2019
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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