SuicideNCT04140149
Living With Hope: A Preliminary Investigation of a Skills Class
An observational study of Suicide and Suicide, Attempted, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Suicide, Attempted, Suicidal Ideation
- What is being tested?
- Living with Hope
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 6 Jul 2021to 10 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Made a suicide attempt in the past 3 months
- Sought mental health crisis services, and referred to the Living with Hope program
- -
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicide, Suicide, Attempted, Suicidal Ideation
- Being tested
- Living with Hope
- Keywords
- Suicide, Suicide Attempt, Suicidal Ideation, Pilot, Intervention
- Medical subject headings
- Suicide, Suicide, Attempted, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living with HopeBehavioural
12-week, CBT-based, psychoeducational skills class
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Living with Hope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores on the Beck Scale for Suicide Ideation
21 item self-report measure of the severity of past-week suicidal ideation
Measured: 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
Measured: 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
Measured: Through the duration of treatment and over follow-up period (approximately 6 months)
Secondary outcomes (16)
Change in scores on The Beck Hopelessness Scale
20-item self-report measure of past-week hopelessness and negative beliefs about the future
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 12 of Living with Hope class session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start6 Jul 2021
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Health Sciences Centre Foundation, Manitoba
- Responsible party
- Principal investigator, Christine Henriksen, University of Manitoba
- Investigators
- Christine A Henriksen, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140149
- Sponsor's protocol ID
- H2019:292
- Status last verified
- Sep 2025
- First submitted
- 21 Oct 2019
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living With Hope: A Preliminary Investigation of a Novel, CBT-Based Psychoeducational Skills Class for Individuals With a Recent Suicide Attempt
- ClinicalTrials.gov ID
- NCT04140149
- Acronym / sponsor ID
- H2019:292
- Conditions
- Suicide, Suicide, Attempted, Suicidal Ideation
- Keywords
- Suicide, Suicide Attempt, Suicidal Ideation, Pilot, Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Health Sciences Centre Foundation, Manitoba
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Behavioral: Living with HopeAdults who have made a suicide attempt in the past 3 months who have been referred to, and enrolled in, the Living with Hope class. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Made a suicide attempt in the past 3 months
- Sought mental health crisis services, and referred to the Living with Hope program
- -
Key exclusion criteria (5 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Living with Hope12-week, CBT-based, psychoeducational skills class | Behavioural | Participants |
Primary outcome
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
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
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
16 secondary outcomes
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
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
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
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
Safety Item
Time frame: Week 1 of Living with Hope class session
Safety Item
Time frame: Week 2 of Living with Hope class session
Safety Item
Time frame: Week 3 of Living with Hope class session
Safety Item
Time frame: Week 4 of Living with Hope class session
Safety Item
Time frame: Week 5 of Living with Hope class session
Safety Item
Time frame: Week 6 of Living with Hope class session
Safety Item
Time frame: Week 7 of Living with Hope class session
Safety Item
Time frame: Week 8 of Living with Hope class session
Safety Item
Time frame: Week 9 of Living with Hope class session
Safety Item
Time frame: Week 10 of Living with Hope class session
Safety Item
Time frame: Week 11 of Living with Hope class session
Safety Item
Time frame: Week 12 of Living with Hope class session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine A Henriksen, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide and Suicide, Attempted, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.