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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05530941
Other study ID # EC/BC-11283
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 3, 2022
Est. completion date March 11, 2022

Study information

Verified date January 2022
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to examine whether the online suicide prevention campaign for men could increase openness about emotions and help-seeking behavior, and decrease hopelessness and adherence to traditional gender norms concerning self-reliance among men. The effectiveness of the campaign will be evaluated in adult men using a pre-post questionnaire study design.


Recruitment information / eligibility

Status Completed
Enrollment 205
Est. completion date March 11, 2022
Est. primary completion date March 2, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Online suicide prevention campaign
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.

Locations

Country Name City State
Belgium Flemish Centre of Expertise in Suicide Prevention, Ghent University Ghent

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Other General distress: Kessler 10 A 10-item questionnaire measuring distress. Each item is scored on a 5-point Likert (1=never, 5=always) Baseline (before intervention)
Other Suicidal ideation and behaviour: Suicidal ideation Attributes Scale & two general questions 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)
Other Campaign evaluation 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. post-test (after three days of access to the campaign)
Primary Change in self-reliance: self-reliance factor of the Conformity to Masculine Norms Inventory (CMNI) 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). Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
Primary Change in Help-seeking behaviour: General Help-Seeking Questionnaire (GHSQ) 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). Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
Primary Change in Openness about emotions: scales "Communication and Expression of Emotions" and "Normative Restrictions of Affectivity" of the Dimensions of Openness to Emotions (DOE) 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)
Primary Change in Hopelessness: Beck Hopelessness Scale (BHS), 4-item version 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. Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
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