Living With Hope: A Preliminary Investigation of a Skills Class

Sponsor
University of Manitoba (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04140149
Collaborator
Health Sciences Centre Foundation, Manitoba (Other)
60
1
31.8
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Living With Hope: A Preliminary Investigation of a Novel, CBT-Based Psychoeducational Skills Class for Individuals With a Recent Suicide Attempt
Actual Study Start Date :
Jul 6, 2021
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Change in scores on the Beck Scale for Suicide 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]

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

  2. Change in scores on the Columbia-Suicide Severity Rating Scale [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 [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 Outcome Measures

  1. Change in scores on The Beck Hopelessness Scale [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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 -

Contacts and Locations

Locations

Site City State Country Postal Code
1 Crisis Response Centre Winnipeg Manitoba Canada R3E 0Y1

Sponsors and Collaborators

  • University of Manitoba
  • Health Sciences Centre Foundation, Manitoba

Investigators

  • Principal Investigator: Christine A Henriksen, PhD, University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christine Henriksen, Assistant Professor, University of Manitoba
ClinicalTrials.gov Identifier:
NCT04140149
Other Study ID Numbers:
  • H2019:292
First Posted:
Oct 25, 2019
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christine Henriksen, Assistant Professor, University of Manitoba
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2022