SuicideNCT06810674
Get Out of Your Head 2.0: Evaluation of an Online Prevention Campaign and Updated Website for Men
A study testing Get out of your head campaign and website 2.0 in people with Suicide and Suicidal Ideation, run by University Ghent at 1 site in Belgium.
Trial summary
The primary objective of this study is to evaluate the perceptions and evaluations of men with suicidal thoughts, regarding the new "Get Out of Your Head" campaign and the updated website. The findings will inform potential adjustments to enhance the campaign and website as needed. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Suicide, Suicidal Ideation
- What is being tested?
- Get out of your head campaign and website 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2025to 1 Oct 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men (≥ 18y/o)
- Experienced suicidal thoughts in the past three year
- Access to a smartphone, tablet, or computer with internet connection
- Proficiency in Dutch
Who cannot join
- Does not meet the specified inclusion criteria.
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
The primary objective of this study is to evaluate the perceptions and evaluations of men with suicidal thoughts, regarding the new "Get Out of Your Head" campaign and the updated website. The findings will inform potential adjustments to enhance the campaign and website as needed.
Read the detailed description
In a previous study (BUN: B6702024000090) the authors focused on identifying these barriers and needs among adult men experiencing suicidal thoughts and their healthcare providers. Findings from this needs assessment suggest that men with suicidal ideation often perceive a lower need for help and hold attitudes that inhibit help-seeking and sustained engagement in care. These attitudes appear closely linked to societal gender norms around emotional openness, self-reliance, and the perceived responsibility to provide for a family. Furthermore, men experiencing suicidal thoughts expressed a desire for information on certain topics that may currently be unavailable.
To address these gaps, a new awareness campaign is being developed, alongside updates to the existing "Get out of your head" website (original: www.komuitjekop.be), incorporating necessary information. The campaign and website updates are being shaped through a participatory co-creation process involving men with a history of suicidal thoughts to ensure relevance and leverage their experiential knowledge (BUN: B6702024000420). In this approach, men with lived experience are central to the decisions on the design and content of the tools. Additionally, input from experts in healthcare and masculinity, as well as international research, is being integrated.
Once the campaign is developed and the website (www.komuitjekop.be) is updated, the authors aim to evaluate how these resources are perceived by men with suicidal thoughts to further refine these suicide prevention efforts.
The primary objective of the current study is to evaluate the perceptions and evaluations of men with suicidal thoughts, regarding the new "Get Out of Your Head" campaign and the updated website. The findings will inform potential adjustments to enhance the campaign and website as needed.
- Conditions
- Suicide, Suicidal Ideation
- Being tested
- Get out of your head campaign and website 2.0
- Medical subject headings
- Suicide, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Get out of your head campaign and website 2.0Behavioural
The Get out of your head campaign and website were launched in 2022 to improve men's mental health and reduce stigma (Stas et al., 2024). Developed with experts, a communication agency, and the target audience, the campaign included videos, testimonies, and a website with tailored information on mental health, suicide prevention, and help-seeking (www.komuitjekop.be).
The new campaign and updated website will focus specifically on facilitating help-seeking behaviour among men experiencing suicidal thoughts by increasing their perceived need for support. More specifically, the new campaign will aim to enhance the recognition of their suffering, the relevance of seeking and receiving help and changing the perception of suicidal thoughts, namely that these are not fixed or part of life, but instead are changeable and can improve with the correct help.
| Study group | Role | What they receive |
|---|---|---|
| Get Out of your head campaign and website 2.0 | Experimental | Participants in this group (all participants) are asked to complete a questionnaire (15-20 min). After completing these measures, participants will view the developed campaign materials (visuals) and will be asked to provide feedback. Subsequently, participants will receive a link to the website, along with instructions to review the new content pages. They will have three days to explore the site before receiving an email prompting them to complete the post-test questionnaire (10-15 min), which will take approximately 10-15 minutes. If the post-test is not completed after seven or eight days, a reminder will be sent. Receives: Behavioral: Get out of your head campaign and website 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experienced need
1 Question based on previous study : to what extent they feel they need support or help from others, on a scale of 0 (not at all) to 10 (a lot), with higher scores indicating a higher perceived need
Measured: Change from Baseline (before intervention) to post-test (after viewing campaign during 3days); time frame of 3 days
Secondary outcomes (4)
Attitudes about suicidal thoughts and help-seeking
5 items from the Attitudes Towards Suicide (ATTS); 3 adapted items from the Attitudes Toward Seeking Professional Psychological Help Scale (ATSPPHS); 4 items from the Network Orientation Scale. All items (12) are to be rated on a scale of 1 (totally disagree) to 5 (totally agree), resulting in a score between 12 and 60.
Measured: Change from Baseline (before intervention) to post-test (after viewing campaign during 3days); time frame of 3 days
Help-seeking intention
Shortened version of the General Helpseeking Questionnaire: 7 items (Healthcare provider; helpline, general practitioner, psychiatrist, close one, other, no one) to be rated on a scale from 1 (extremely unlikely) to 7 (extremely likely) of how likely they are to ask those people for help. Higher scores indicate a higher intention to seek help. Range: 7-49.
Measured: Change from Baseline (before intervention) to post-test (after viewing campaign during 3days); time frame of 3 days
Evaluation of the campaign materials
Evaluation statements and open questions for feedback: would they visit the website (yes/no), which information would they expect on the website (open question); 10 statements to be rated on a scale of 1 (totally disagree) to 5 (totally agree); 3 open questions for feedback
Measured: Baseline
Evaluation of the new/updated webcontent
Evaluation statements and open questions for feedback: 9 statements to be rated on a scale of 1 (totally disagree) to 5 (totally agree); 3 open questions for feedback.
Measured: Post-test (after viewing campaign), assessed 3 days after pretest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Oct 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025
Why it stopped: the campaign section has not yet been finalised. A preliminary evaluation is difficult in this case, as the impact stems primarily from a media campaign and PR initiatives. Such effects are harder to assess in advance. Consequently, this specific stu
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwendolyn Portzky, PhD, Principal investigator, Flemish Centre of Expertise in Suicide Prevention (Ghent University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810674
- Sponsor's protocol ID
- ONZ-2024-0537
- Status last verified
- Sep 2026
- First submitted
- 22 Jan 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hanlon CA, Chopra J, Boland J, McIlroy D, Poole H, Saini P. A mixed-methods evaluation of the acceptability and fidelity of the James' Place model for men experiencing suicidal crisis. Health Psychol Behav Med. 2023 Oct 11;11(1):2265142. doi: 10.1080/21642850.2023.2265142. eCollection 2023.
PubMed 37842012Boyle, E. (2007),
Watling D, Preece M, Hawgood J, Bloomfield S, Kolves K. Developing an Intervention for Suicide Prevention: A Rapid Review of Lived Experience Involvement. Arch Suicide Res. 2022 Apr-Jun;26(2):465-480. doi: 10.1080/13811118.2020.1833799. Epub 2020 Oct 18.
PubMed 33073734Stas P, De Jaegere E, van Heeringen K, Ballon A, Portzky G. Evaluation of an online suicide prevention campaign targeting men. Suicide Life Threat Behav. 2024 Feb;54(1):95-107. doi: 10.1111/sltb.13021. Epub 2023 Nov 16.
PubMed 37970735Renberg ES, Jacobsson L. Development of a questionnaire on attitudes towards suicide (ATTS) and its application in a Swedish population. Suicide Life Threat Behav. 2003 Spring;33(1):52-64. doi: 10.1521/suli.33.1.52.22784.
PubMed 12710540Mackenzie, C. S., Knox, V. J., Gekoski, W. L., & Macaulay, H. L. (2004). An Adaptation and Extension of the Attitudes Toward Seeking Professional Psychological Help Scale. Journal of Applied Social Psychology, 34(11), 2410-2435. https://doi.org/10.1111/j.1559-1816.2004.tb01984.x
Fischer, E. H., Farina, A. (1995). Attitudes toward seeking professional psychological help: A shortened form and considerations for research. Journal of College Student Development, 36, 368-373.
Vaux, A. (1985). Factor Structure of the Network Orientation Scale. Psychological Reports, 57(3_suppl), 1181-1182. https://doi.org/10.2466/pr0.1985.57.3f.1181
Wilson, C. J., Deane, F. P., Ciarrochi, J. V., & Rickwood, D. (2005). Measuring help seeking intentions: properties of the general help seeking questionnaire.
Tang S, Reily NM, Arena AF, Batterham PJ, Calear AL, Carter GL, Mackinnon AJ, Christensen H. People Who Die by Suicide Without Receiving Mental Health Services: A Systematic Review. Front Public Health. 2022 Jan 18;9:736948. doi: 10.3389/fpubh.2021.736948. eCollection 2021.
PubMed 35118036Gisle, L., Drieskens, S., Demarest, S., & van der Heyden, J. (2020). Geestelijke gezondheid: Gezondheidsenquête 2018. www.gezondheidsenquete.be
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Get Out of Your Head 2.0: Evaluation of an Online Prevention Campaign and Updated Website for Men
- ClinicalTrials.gov ID
- NCT06810674
- Acronym / sponsor ID
- ONZ-2024-0537
- Conditions
- Suicide, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the campaign section has not yet been finalised. A preliminary evaluation is difficult in this case, as the impact stems primarily from a media campaign and PR initiatives. Such effects are harder to assess in advance. Consequently, this specific stu
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 5 Feb 2025 (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.
The primary objective of this study is to evaluate the perceptions and evaluations of men with suicidal thoughts, regarding the new "Get Out of Your Head" campaign and the updated website. The findings will inform potential adjustments to enhance the campaign and website as needed.
Detailed description
In a previous study (BUN: B6702024000090) the authors focused on identifying these barriers and needs among adult men experiencing suicidal thoughts and their healthcare providers. Findings from this needs assessment suggest that men with suicidal ideation often perceive a lower need for help and hold attitudes that inhibit help-seeking and sustained engagement in care. These attitudes appear closely linked to societal gender norms around emotional openness, self-reliance, and the perceived responsibility to provide for a family. Furthermore, men experiencing suicidal thoughts expressed a desire for information on certain topics that may currently be unavailable.
To address these gaps, a new awareness campaign is being developed, alongside updates to the existing "Get out of your head" website (original: www.komuitjekop.be), incorporating necessary information. The campaign and website updates are being shaped through a participatory co-creation process involving men with a history of suicidal thoughts to ensure relevance and leverage their experiential knowledge (BUN: B6702024000420). In this approach, men with lived experience are central to the decisions on the design and content of the tools. Additionally, input from experts in healthcare and masculinity, as well as international research, is being integrated.
Once the campaign is developed and the website (www.komuitjekop.be) is updated, the authors aim to evaluate how these resources are perceived by men with suicidal thoughts to further refine these suicide prevention efforts.
The primary objective of the current study is to evaluate the perceptions and evaluations of men with suicidal thoughts, regarding the new "Get Out of Your Head" campaign and the updated website. The findings will inform potential adjustments to enhance the campaign and website as needed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Get Out of your head campaign and website 2.0 | Experimental | Behavioral: Get out of your head campaign and website 2.0Participants in this group (all participants) are asked to complete a questionnaire (15-20 min). After completing these measures, participants will view the developed campaign materials (visuals) and will be asked to provide feedback. Subsequently, participants will receive a link to the website, along with instructions to review the new content pages. They will have three days to explore the site before receiving an email prompting them to complete the post-test questionnaire (10-15 min), which will take approximately 10-15 minutes. If the post-test is not completed after seven or eight days, a reminder will be sent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men (≥ 18y/o)
- Experienced suicidal thoughts in the past three year
- Access to a smartphone, tablet, or computer with internet connection
- Proficiency in Dutch
Key exclusion criteria (1 listed)
- Does not meet the specified inclusion criteria.
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 |
|---|---|---|
| Get out of your head campaign and website 2.0The Get out of your head campaign and website were launched in 2022 to improve men's mental health and reduce stigma (Stas et al., 2024). Developed with experts, a communication agency, and the target audience, the campaign included videos, testimonies, and a website with tailored information on mental health, suicide prevention, and help-seeking (www.komuitjekop.be). The new campaign and updated website will focus specifically on facilitating help-seeking behaviour among men experiencing suicidal thoughts by increasing their perceived need for support. More specifically, the new campaign will aim to enhance the recognition of their suffering, the relevance of seeking and receiving help and changing the perception of suicidal thoughts, namely that these are not fixed or part of life, but instead are changeable and can improve with the correct help. | Behavioural | Get Out of your head campaign and website 2.0 |
Primary outcome
Experienced need
Time frame: Change from Baseline (before intervention) to post-test (after viewing campaign during 3days); time frame of 3 days
1 Question based on previous study : to what extent they feel they need support or help from others, on a scale of 0 (not at all) to 10 (a lot), with higher scores indicating a higher perceived need
4 secondary outcomes
Attitudes about suicidal thoughts and help-seeking
Time frame: Change from Baseline (before intervention) to post-test (after viewing campaign during 3days); time frame of 3 days
Help-seeking intention
Time frame: Change from Baseline (before intervention) to post-test (after viewing campaign during 3days); time frame of 3 days
Evaluation of the campaign materials
Time frame: Baseline
Evaluation of the new/updated webcontent
Time frame: Post-test (after viewing campaign), assessed 3 days after pretest
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 37842012Hanlon CA, Chopra J, Boland J, McIlroy D, Poole H, Saini P. A mixed-methods evaluation of the acceptability and fidelity of the James' Place model for men experiencing suicidal crisis. Health Psychol Behav Med. 2023 Oct 11;11(1):2265142. doi: 10.1080/21642850.2023.2265142. eCollection 2023.
- BackgroundBoyle, E. (2007),
- Background: PubMed 33073734Watling D, Preece M, Hawgood J, Bloomfield S, Kolves K. Developing an Intervention for Suicide Prevention: A Rapid Review of Lived Experience Involvement. Arch Suicide Res. 2022 Apr-Jun;26(2):465-480. doi: 10.1080/13811118.2020.1833799. Epub 2020 Oct 18.
- Background: PubMed 37970735Stas P, De Jaegere E, van Heeringen K, Ballon A, Portzky G. Evaluation of an online suicide prevention campaign targeting men. Suicide Life Threat Behav. 2024 Feb;54(1):95-107. doi: 10.1111/sltb.13021. Epub 2023 Nov 16.
- Background: PubMed 12710540Renberg ES, Jacobsson L. Development of a questionnaire on attitudes towards suicide (ATTS) and its application in a Swedish population. Suicide Life Threat Behav. 2003 Spring;33(1):52-64. doi: 10.1521/suli.33.1.52.22784.
- BackgroundMackenzie, C. S., Knox, V. J., Gekoski, W. L., & Macaulay, H. L. (2004). An Adaptation and Extension of the Attitudes Toward Seeking Professional Psychological Help Scale. Journal of Applied Social Psychology, 34(11), 2410-2435. https://doi.org/10.1111/j.1559-1816.2004.tb01984.x
- BackgroundFischer, E. H., Farina, A. (1995). Attitudes toward seeking professional psychological help: A shortened form and considerations for research. Journal of College Student Development, 36, 368-373.
- BackgroundVaux, A. (1985). Factor Structure of the Network Orientation Scale. Psychological Reports, 57(3_suppl), 1181-1182. https://doi.org/10.2466/pr0.1985.57.3f.1181
- BackgroundWilson, C. J., Deane, F. P., Ciarrochi, J. V., & Rickwood, D. (2005). Measuring help seeking intentions: properties of the general help seeking questionnaire.
- Background: PubMed 35118036Tang S, Reily NM, Arena AF, Batterham PJ, Calear AL, Carter GL, Mackinnon AJ, Christensen H. People Who Die by Suicide Without Receiving Mental Health Services: A Systematic Review. Front Public Health. 2022 Jan 18;9:736948. doi: 10.3389/fpubh.2021.736948. eCollection 2021.
- BackgroundGisle, L., Drieskens, S., Demarest, S., & van der Heyden, J. (2020). Geestelijke gezondheid: Gezondheidsenquête 2018. www.gezondheidsenquete.be
- 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
Flemish Centre of Expertise in Suicide Prevention (Ghent University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Get out of your head campaign and website 2.0 in people with Suicide and Suicidal Ideation, 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 1 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: withdrawn, as of the sponsor's last update on 21 Sep 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Experienced need (time frame: Change from Baseline (before intervention) to post-test (after viewing campaign during 3days); time frame of 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06810674, which also lists 11 linked publications.
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 21 Sep 2026.