- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05530941
Online Suicide Prevention Campaign Aimed at Men
Evaluation of an Online Suicide Prevention Campaign Aimed at Men to Promote Help-seeking and Peer Support
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ghent, Belgium, 9000
- Flemish Centre of Expertise in Suicide Prevention, Ghent University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Gender identity: male
- ≥ 18 years old
- Have access to internet and a computer/tablet/smartphone
- Speak Dutch
Exclusion Criteria:
- Gender identity: female or other
- < 18 years old
- No acces to internet and a computer/tablet/smartphone
- Non-Dutch speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Intervention group
Participants in this group (all participants) were asked to complete a questionnaire and then received access to the online prevention campaign during three days, after which they were asked to complete another questionnaire.
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The online prevention campaign consists of two campaign videos, a website with information about suicide prevention and mental health tailored to men, and testimonials of men who struggled with their mental health.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in self-reliance: self-reliance factor of the Conformity to Masculine Norms Inventory (CMNI)
Time Frame: Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
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The CMNI is a 22 item scale to measure adherence to traditional Western masculine norms and values across 11 domains.
The self-reliance scale consists of 5 items measured on a 4-point Likert scale (1= strongly disagree to 4= strongly agree).
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Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
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Change in Help-seeking behaviour: General Help-Seeking Questionnaire (GHSQ)
Time Frame: Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
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The GHSQ measures two aspects of help-seeking, namely when facing personal or emotional problems and when facing suicidal ideation.
For each aspect participants indicate how likely (1= extremely unlikely, 7= extremely likely) it is that they would seek help from different kind of sources (10 types).
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Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
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Change in Openness about emotions: scales "Communication and Expression of Emotions" and "Normative Restrictions of Affectivity" of the Dimensions of Openness to Emotions (DOE)
Time Frame: Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
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The Dimensions of Openness to Emotions is a 36 item questionnaire measuring emotional openness. The "Communication and Expression of Emotions" and "Normative Restrictions of Affectivity" consist of, respectively, 7 and 5 items to be scored on a 5-point Likert scale (0=not at all, 4= completely) |
Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
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Change in Hopelessness: Beck Hopelessness Scale (BHS), 4-item version
Time Frame: Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
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A 4-item self-report questionnaire to measure hopelessness in adolescents and adults.
Each item is rated as 'true' (score = 1) or 'false' (score = 0) for them over the past week, resulting in a total score ranging from 0 to 4, with higher scores indicating higher levels of hopelessness.
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Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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General distress: Kessler 10
Time Frame: Baseline (before intervention)
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A 10-item questionnaire measuring distress.
Each item is scored on a 5-point Likert (1=never, 5=always)
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Baseline (before intervention)
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Suicidal ideation and behaviour: Suicidal ideation Attributes Scale & two general questions
Time Frame: Baseline (before intervention)
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A 5-item questionnaire to measure presence of suicidal thoughts and the severity of these thoughts. Each item is scored on a 11-point Likert scale. Participants were asked whether they ever had had suicidal thoughts (if yes, in the last 12 months?) and whether they ever (if yes, in the last 12 months?) had attempted suicide. |
Baseline (before intervention)
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Campaign evaluation
Time Frame: post-test (after three days of access to the campaign)
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14 evaluative statements about the general campaign and specific aspects of the campaign to be rated on a 5-point Likert scale (Totally disagree, disagree, neutral, agree, totally disagree).
Additionally three open questions where participants can give feedback about what they liked/did not like/ general comments.
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post-test (after three days of access to the campaign)
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Collaborators and Investigators
Sponsor
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 (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC/BC-11283
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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