- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04140149
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3E 0Y1
- Crisis Response Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 -
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
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.
|
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
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 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
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
|
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
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
|
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
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
|
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
|
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
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
|
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
|
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
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
|
Week 1 of Living with Hope class session
|
|
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
|
Week 2 of Living with Hope class session
|
|
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
|
Week 3 of Living with Hope class session
|
|
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
|
Week 4 of Living with Hope class session
|
|
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
|
Week 5 of Living with Hope class session
|
|
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
|
Week 6 of Living with Hope class session
|
|
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
|
Week 7 of Living with Hope class session
|
|
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
|
Week 8 of Living with Hope class session
|
|
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
|
Week 9 of Living with Hope class session
|
|
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
|
Week 10 of Living with Hope class session
|
|
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
|
Week 11 of Living with Hope class session
|
|
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
|
Week 12 of Living with Hope class session
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christine A Henriksen, PhD, University of Manitoba
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2019:292
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Suicidal Ideation
-
Northwestern UniversityNot yet recruitingSuicidal Ideation and Behavior
-
University GhentRecruitingSuicide | Suicidal Ideation and Behavior | Crisis InterventionBelgium
-
Shira BarzilaySchneider Children's Medical Center, IsraelRecruiting
-
University of WashingtonUnited States Department of Defense; Military Suicide Research ConsortiumCompletedSuicidal and Self-injurious Behavior | Suicidal Ideation ActiveUnited States
-
The Catholic University of AmericaUniversity of Washington; VA Office of Research and DevelopmentCompletedSuicidal and Self-injurious Behavior | Suicidal Ideation Active
-
Emory UniversityGeorgia Institute of TechnologyCompletedSuicide, Suicidal IdeationUnited States
-
Columbia UniversityNational Institute of Mental Health (NIMH)RecruitingSuicidal Ideation and BehaviorUnited States
-
Bradley HospitalNational Institute of Mental Health (NIMH); Instituto Nacional de Psiquiatría...Not yet recruitingSuicidal Ideation/BehaviorMexico
-
Oriana Arellano FaúndezActive, not recruitingSuicidal Ideation | Suicidal Ideation and BehaviorsChile
-
VA Office of Research and DevelopmentJames J. Peters Veterans Affairs Medical Center; VISN 2 Mental Illness Research... and other collaboratorsRecruitingHealth | Reintegration Difficulties | Suicidal Ideation and Behaviors | ConnectednessUnited States
Clinical Trials on Living with Hope
-
University of SaskatchewanCompleted
-
University of AlbertaCompleted
-
University of ArkansasNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Northwestern... and other collaboratorsCompletedDiabetesUnited States
-
King's College LondonRecruitingLiver Diseases | Heart Diseases | Heart Failure | Stroke | Cerebrovascular Disorders | Epilepsy | Pain | Multiple Sclerosis | Hypertension | Obesity | Diabetes | Cancer | Arthritis | Osteoarthritis | Rheumatoid Arthritis | Parkinson Disease | Migraine | Hepatitis | Atrial Fibrillation | Asthma | Endometriosis | Dementia | Fibromyalgia | Celiac... and other conditionsUnited Kingdom
-
Texas A&M UniversityBlue Cross Blue ShieldCompletedDiabetes Mellitus, Type 2United States
-
University of Sao PauloCompletedSystemic Lupus ErythematosusBrazil
-
Central South UniversityUniversity of California, Los AngelesUnknown
-
Georgia Southern UniversityCompletedDevelopmental Disabilities | Health Education | Community Health Services | Health Services for Persons With DisabilitiesUnited States