NCT05530941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2022

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
Last Updated

September 7, 2022

Status Verified

January 1, 2022

Enrollment Period

27 days

First QC Date

May 31, 2022

Last Update Submit

September 6, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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)

Other Outcomes (3)

  • General distress: Kessler 10

    Baseline (before intervention)

  • Suicidal ideation and behaviour: Suicidal ideation Attributes Scale & two general questions

    Baseline (before intervention)

  • Campaign evaluation

    post-test (after three days of access to the campaign)

Study Arms (1)

Intervention group

EXPERIMENTAL

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.

Behavioral: Online suicide prevention campaign

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gender identity: male
  • ≥ 18 years old
  • Have access to internet and a computer/tablet/smartphone
  • Speak Dutch

You may not qualify if:

  • Gender identity: female or other
  • \< 18 years old
  • No acces to internet and a computer/tablet/smartphone
  • Non-Dutch speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Flemish Centre of Expertise in Suicide Prevention, Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Help-Seeking BehaviorSuicide

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorSelf-Injurious BehaviorBehavioral Symptoms

Study Officials

  • Gwendolyn Portzky, Phd

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2022

First Posted

September 7, 2022

Study Start

February 3, 2022

Primary Completion

March 2, 2022

Study Completion

March 11, 2022

Last Updated

September 7, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations