Help-Seeking BehaviorNCT05530941
Online Suicide Prevention Campaign Aimed at Men
A study testing Online suicide prevention campaign in people with Help-Seeking Behavior and Suicide, run by University Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Help-Seeking Behavior, Suicide
- What is being tested?
- Online suicide prevention campaign
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Feb 2022to 11 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gender identity: male
- ≥ 18 years old
- Have access to internet and a computer/tablet/smartphone
- Speak Dutch
Who cannot join
- Gender identity: female or other
- < 18 years old
- No acces to internet and a computer/tablet/smartphone
- Non-Dutch speaking
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Flemish Centre of Expertise in Suicide Prevention, Ghent University
Ghent, 9000
About this study
Official title: Evaluation of an Online Suicide Prevention Campaign Aimed at Men to Promote Help-seeking and Peer Support
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.
- Conditions
- Help-Seeking Behavior, Suicide
- Being tested
- Online suicide prevention campaign
- Medical subject headings
- Help-Seeking Behavior, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online suicide prevention campaignBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Online suicide prevention campaign |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start3 Feb 2022
- Primary completion2 Mar 2022
- Study completion11 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Help-Seeking BehaviorStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwendolyn Portzky, Phd, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530941
- Sponsor's protocol ID
- EC/BC-11283
- Status last verified
- Jan 2022
- First submitted
- 31 May 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Online Suicide Prevention Campaign Aimed at Men to Promote Help-seeking and Peer Support
- ClinicalTrials.gov ID
- NCT05530941
- Acronym / sponsor ID
- EC/BC-11283
- Conditions
- Help-Seeking Behavior, Suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 3 Feb 2022 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Online suicide prevention campaignParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Gender identity: male
- ≥ 18 years old
- Have access to internet and a computer/tablet/smartphone
- Speak Dutch
Key exclusion criteria (4 listed)
- Gender identity: female or other
- < 18 years old
- No acces to internet and a computer/tablet/smartphone
- Non-Dutch speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online suicide prevention campaignThe 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. | Behavioural | Intervention group |
Primary outcome
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)
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)
Time frame: Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
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)
Time frame: Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
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
Time frame: Change from Baseline (before intervention) to post-test (after three days of access to the campaign)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwendolyn Portzky, Phd principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online suicide prevention campaign in people with Help-Seeking Behavior and Suicide, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.