NCT06810674

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

February 5, 2025

Status Verified

January 1, 2025

Enrollment Period

10 months

First QC Date

January 22, 2025

Last Update Submit

January 31, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    Change from Baseline (before intervention) to post-test (after viewing campaign during 3days); time frame of 3 days

  • Help-seeking intention

    Change from Baseline (before intervention) to post-test (after viewing campaign during 3days); time frame of 3 days

  • Evaluation of the campaign materials

    Baseline

  • Evaluation of the new/updated webcontent

    Post-test (after viewing campaign), assessed 3 days after pretest

Other Outcomes (2)

  • Socio-demographic characteristics

    Baseline

  • Suicidality

    Baseline

Study Arms (1)

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.

Behavioral: Get out of your head campaign and website 2.0

Interventions

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.

Get Out of your head campaign and website 2.0

Eligibility Criteria

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

You may qualify if:

  • Men (≥ 18y/o)
  • Experienced suicidal thoughts in the past three year
  • Access to a smartphone, tablet, or computer with internet connection
  • Proficiency in Dutch

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

Related Publications (11)

  • 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.

    PMID: 37842012BACKGROUND
  • Boyle, E. (2007),

    BACKGROUND
  • 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.

    PMID: 33073734BACKGROUND
  • Stas 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.

    PMID: 37970735BACKGROUND
  • Renberg 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.

    PMID: 12710540BACKGROUND
  • Mackenzie, 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND
  • Wilson, C. J., Deane, F. P., Ciarrochi, J. V., & Rickwood, D. (2005). Measuring help seeking intentions: properties of the general help seeking questionnaire.

    BACKGROUND
  • 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.

    PMID: 35118036BACKGROUND
  • Gisle, L., Drieskens, S., Demarest, S., & van der Heyden, J. (2020). Geestelijke gezondheid: Gezondheidsenquête 2018. www.gezondheidsenquete.be

    BACKGROUND

MeSH Terms

Conditions

SuicideSuicidal Ideation

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Gwendolyn Portzky, PhD

    Flemish Centre of Expertise in Suicide Prevention (Ghent University)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

January 22, 2025

First Posted

February 5, 2025

Study Start

March 1, 2025

Primary Completion

December 15, 2025

Study Completion

December 15, 2025

Last Updated

February 5, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations