NCT04140149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

July 6, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2023

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

2.1 years

First QC Date

October 21, 2019

Last Update Submit

September 8, 2025

Conditions

Keywords

SuicideSuicide AttemptSuicidal IdeationPilotIntervention

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (16)

  • 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

  • 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

  • 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

  • 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

  • Safety Item

    Week 1 of Living with Hope class session

  • +11 more secondary outcomes

Study Arms (1)

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

Interventions

12-week, CBT-based, psychoeducational skills class

Participants

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Crisis Response Centre

Winnipeg, Manitoba, R3E 0Y1, Canada

Location

MeSH Terms

Conditions

SuicideSuicide, AttemptedSuicidal Ideation

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Christine A Henriksen, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 25, 2019

Study Start

July 6, 2021

Primary Completion

August 10, 2023

Study Completion

August 10, 2023

Last Updated

September 15, 2025

Record last verified: 2025-09

Locations