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Online Suicide Prevention Campaign Aimed at Men

Primary Purpose

Help-Seeking Behavior, Suicide

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Online suicide prevention campaign
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Help-Seeking Behavior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Flemish Centre of Expertise in Suicide Prevention, Ghent University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

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.

Outcomes

Primary Outcome Measures

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 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 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 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.

Secondary Outcome Measures

Full Information

First Posted
May 31, 2022
Last Updated
September 6, 2022
Sponsor
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT05530941
Brief Title
Online Suicide Prevention Campaign Aimed at Men
Official Title
Evaluation of an Online Suicide Prevention Campaign Aimed at Men to Promote Help-seeking and Peer Support
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 3, 2022 (Actual)
Primary Completion Date
March 2, 2022 (Actual)
Study Completion Date
March 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Help-Seeking Behavior, Suicide

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwendolyn Portzky, Phd
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Flemish Centre of Expertise in Suicide Prevention, Ghent University
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Online Suicide Prevention Campaign Aimed at Men

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