Suicidal IdeationNCT05458830
Breaking Down Barriers to a Suicide Prevention Helpline
A study testing Brief Barrier Reduction Intervention and Plain advisory text in people with Suicidal Ideation, run by 113 Suicide Prevention at 1 site in Netherlands.
Trial summary
Every month, around four thousand people fill in the anonymous self-test for suicidal thoughts on the website of the Dutch suicide prevention helpline 113 Suicide Prevention. The self-test includes the Suicidal Ideation Attributes Scale (SIDAS) and informs people about the severity of their suicidal thoughts. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Brief Barrier Reduction Intervention and Plain advisory text
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 775 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Oct 2022to 1 Apr 2023
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- participant is younger than 16 years old.
- participant scores below the cut-off point for severe suicidal thoughts (SIDAS score < 21).
- participant scores above the cut-off point for severe suicidal thoughts (SIDAS score ≥ 21) and reports being likely to contact the suicide prevention helpline. They will be directly transferred to the contact details of the helpline.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breaking Down Barriers to a Suicide Prevention Helpline: a Web-based Randomised Controlled Trial
Every month, around four thousand people fill in the anonymous self-test for suicidal thoughts on the website of the Dutch suicide prevention helpline 113 Suicide Prevention. The self-test includes the Suicidal Ideation Attributes Scale (SIDAS) and informs people about the severity of their suicidal thoughts. The vast majority (70%) of people who complete the test score higher than the cut-off point (≥ 21) for severe suicidal thoughts. Despite this, only around 10% of test-takers navigate to the webpage about contacting the helpline.
In this study the investigators test an intervention that aims to reduce barriers to contacting the helpline via chat or phone. People with severe suicidal thoughts and little motivation to contact the helpline will be randomly allocated either to a brief Barrier Reduction Intervention (BRI) or care as usual, a plain advisory text.
The aim of our study is two-fold: (i) to measure the effectiveness of a brief barrier reduction intervention (BRI) in the self-test motivating people with severe suicidal thoughts to contact the helpline, and (ii) to specifically evaluate the effectiveness of the intervention in increasing service utilisation by high-risk groups for suicide such as men and people of middle age.
Read the detailed description
Research suggests that people with suicidal thoughts often do not seek help, making them invisible for preventive measures and targeted support. Anonymous online help can be a low-threshold first step towards professional face-to-face help. In the Netherlands, the suicide prevention organisation '113 Suicide Prevention' provides around-the-clock anonymous support by phone and chat, as well as an online self-help course, self-assessment tests and brief online coaching and therapy. Apart from the homepage, the 'test yourself' page is the most visited section of the helpline's website. Every month, more than 4,000 people fill in the anonymous self-test for suicidal thoughts. This self-test includes the Suicidal Ideation Attributes Scale (SIDAS) and informs the test-taker of the severity of their suicidal thoughts. Although the vast majority of people who complete the test score higher than the cut-off point for severe suicidal thoughts, only approximately 10% of test-takers go on to navigate to the web-page about contacting the helpline. And although due to the anonymity of the helpline's services it is not possible to know if people follow up the advice of contacting the helpline, the difference in demographic distributions between the users of the self-test and the crisis helpline confirms the assumption that a substantial group does not continue using helpline service. While the percentage of men among the self-test users is 40%, it is only around 25% among the users of the helpline.
The study is designed as a randomised controlled trial for the anonymous users of an online self-test for suicidal thoughts in which individuals with severe suicidal thoughts and no interest in contacting the helpline will be randomly allocated either to a short barrier reduction intervention (BRI) or receive a general advisory text (care as usual). To minimise the burden on our high-risk and sensitive study population, the investigators aim that it is feasible for the participants to complete the intervention within 10 minutes.
The aim of our study is two-fold: (i) to measure the effectiveness of a brief barrier reduction intervention (BRI) in the self-test motivating people with severe suicidal thoughts to contact the helpline, and (ii) to specifically evaluate the effectiveness of the intervention in increasing service utilisation by high-risk groups for suicide such as men and people of middle age.
- Conditions
- Suicidal Ideation
- Being tested
- Brief Barrier Reduction Intervention, Plain advisory text
- Keywords
- Barrier reduction intervention, Suicidal ideation, Self-help, Suicide prevention helpline, Randomised controlled trial, Help-seeking
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Barrier Reduction InterventionBehavioural
After selecting a barrier in the barrier survey, participants receive tailored information with the purpose of addressing common concerns and misconceptions about the helpline.
Plain advisory textBehavioural
Also called care as usual
Care as usual
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | After selecting a barrier in the barrier survey, participants receive tailored information with the purpose of addressing common concerns and misconceptions about the helpline. Receives: Behavioral: Brief Barrier Reduction Intervention |
| Care as usual | Other | Plain advisory text Receives: Behavioral: Plain advisory text |
What is being measured
The primary outcome is the main question the study is designed to answer.
The use of a direct link to the helpline
The primary outcome measure is the use of a direct link to the helpline after completing the intervention or the control condition (plain advisory text, care as usual).
Measured: immediately after intervention
Secondary outcomes (1)
Self-reported likelihood of contacting the helpline
Due to the anonymous nature of the helpline, it is not possible to measure if people who do not directly use the link to the helpline, contact the helpline at a later point in time. Therefore, the self-reported likelihood of contacting the helpline (5-point interval scale, ranging from not likely to very likely) is included as a proxy measurement.
Measured: immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start7 Oct 2022
- Primary completion5 Dec 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is designed as a randomised controlled trial for the anonymous users of an online self-test for suicidal thoughts in which individuals with severe suicidal thoughts and no interest in contacting the helpline will be randomly allocated either to a short barrier reduction intervention (BRI) or receive a general advisory text (care as usual). To minimise the burden on the high-risk and sensitive study population, the investigators aim that it is feasible to complete the intervention within 10 minutes.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 775 participants (actual)
Sponsor and investigators
- Lead sponsor
- 113 Suicide Prevention
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saskia Mérelle, Principal investigator, 113 Suicide Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458830
- Sponsor's protocol ID
- Selftest113
- Other IDs
- 2021.0443
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be made available upon request
Publications
van der Burgt MCA, Merelle S, Brinkman WP, Beekman ATF, Gilissen R. Breaking Down Barriers to a Suicide Prevention Helpline: Protocol for a Web-Based Randomized Controlled Trial. JMIR Res Protoc. 2023 Apr 24;12:e41078. doi: 10.2196/41078.
PubMed 37093641
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breaking Down Barriers to a Suicide Prevention Helpline: a Web-based Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05458830
- Acronym / sponsor ID
- Selftest113
- Conditions
- Suicidal Ideation
- Keywords
- Barrier reduction intervention, Suicidal ideation, Self-help, Suicide prevention helpline, Randomised controlled trial, Help-seeking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 775 participants (actual)
- Lead sponsor
- 113 Suicide PreventionUniversity, hospital or other
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 14 Jul 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.
Every month, around four thousand people fill in the anonymous self-test for suicidal thoughts on the website of the Dutch suicide prevention helpline 113 Suicide Prevention. The self-test includes the Suicidal Ideation Attributes Scale (SIDAS) and informs people about the severity of their suicidal thoughts. The vast majority (70%) of people who complete the test score higher than the cut-off point (≥ 21) for severe suicidal thoughts. Despite this, only around 10% of test-takers navigate to the webpage about contacting the helpline.
In this study the investigators test an intervention that aims to reduce barriers to contacting the helpline via chat or phone. People with severe suicidal thoughts and little motivation to contact the helpline will be randomly allocated either to a brief Barrier Reduction Intervention (BRI) or care as usual, a plain advisory text.
The aim of our study is two-fold: (i) to measure the effectiveness of a brief barrier reduction intervention (BRI) in the self-test motivating people with severe suicidal thoughts to contact the helpline, and (ii) to specifically evaluate the effectiveness of the intervention in increasing service utilisation by high-risk groups for suicide such as men and people of middle age.
Detailed description
Research suggests that people with suicidal thoughts often do not seek help, making them invisible for preventive measures and targeted support. Anonymous online help can be a low-threshold first step towards professional face-to-face help. In the Netherlands, the suicide prevention organisation '113 Suicide Prevention' provides around-the-clock anonymous support by phone and chat, as well as an online self-help course, self-assessment tests and brief online coaching and therapy. Apart from the homepage, the 'test yourself' page is the most visited section of the helpline's website. Every month, more than 4,000 people fill in the anonymous self-test for suicidal thoughts. This self-test includes the Suicidal Ideation Attributes Scale (SIDAS) and informs the test-taker of the severity of their suicidal thoughts. Although the vast majority of people who complete the test score higher than the cut-off point for severe suicidal thoughts, only approximately 10% of test-takers go on to navigate to the web-page about contacting the helpline. And although due to the anonymity of the helpline's services it is not possible to know if people follow up the advice of contacting the helpline, the difference in demographic distributions between the users of the self-test and the crisis helpline confirms the assumption that a substantial group does not continue using helpline service. While the percentage of men among the self-test users is 40%, it is only around 25% among the users of the helpline.
The study is designed as a randomised controlled trial for the anonymous users of an online self-test for suicidal thoughts in which individuals with severe suicidal thoughts and no interest in contacting the helpline will be randomly allocated either to a short barrier reduction intervention (BRI) or receive a general advisory text (care as usual). To minimise the burden on our high-risk and sensitive study population, the investigators aim that it is feasible for the participants to complete the intervention within 10 minutes.
The aim of our study is two-fold: (i) to measure the effectiveness of a brief barrier reduction intervention (BRI) in the self-test motivating people with severe suicidal thoughts to contact the helpline, and (ii) to specifically evaluate the effectiveness of the intervention in increasing service utilisation by high-risk groups for suicide such as men and people of middle age.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study is designed as a randomised controlled trial for the anonymous users of an online self-test for suicidal thoughts in which individuals with severe suicidal thoughts and no interest in contacting the helpline will be randomly allocated either to a short barrier reduction intervention (BRI) or receive a general advisory text (care as usual). To minimise the burden on the high-risk and sensitive study population, the investigators aim that it is feasible to complete the intervention within 10 minutes.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Brief Barrier Reduction InterventionAfter selecting a barrier in the barrier survey, participants receive tailored information with the purpose of addressing common concerns and misconceptions about the helpline. |
| Care as usual | Other | Behavioral: Plain advisory textPlain advisory text |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- participant is younger than 16 years old.
- participant scores below the cut-off point for severe suicidal thoughts (SIDAS score < 21).
- participant scores above the cut-off point for severe suicidal thoughts (SIDAS score ≥ 21) and reports being likely to contact the suicide prevention helpline. They will be directly transferred to the contact details of the helpline.
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 |
|---|---|---|
| Brief Barrier Reduction InterventionAfter selecting a barrier in the barrier survey, participants receive tailored information with the purpose of addressing common concerns and misconceptions about the helpline. | Behavioural | Intervention |
| Plain advisory textAlso: care as usualCare as usual | Behavioural | Care as usual |
Primary outcome
The use of a direct link to the helpline
Time frame: immediately after intervention
The primary outcome measure is the use of a direct link to the helpline after completing the intervention or the control condition (plain advisory text, care as usual).
1 secondary outcome
Self-reported likelihood of contacting the helpline
Time frame: immediately after intervention
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 13 Jul 2023.
- Derived from this study: PubMed 37093641van der Burgt MCA, Merelle S, Brinkman WP, Beekman ATF, Gilissen R. Breaking Down Barriers to a Suicide Prevention Helpline: Protocol for a Web-Based Randomized Controlled Trial. JMIR Res Protoc. 2023 Apr 24;12:e41078. doi: 10.2196/41078.
- Individual participant dataSharing planned: No. The data will be made available upon request
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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.
Saskia Mérelle principal investigator
113 Suicide Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Barrier Reduction Intervention and Plain advisory text in people with Suicidal Ideation, run by 113 Suicide Prevention at 1 site in Netherlands.
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 0 inclusion and 3 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 13 Jul 2023. 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 Netherlands. 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?
The use of a direct link to the helpline (time frame: immediately after intervention). 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 NCT05458830, which also lists 1 linked publication.
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 13 Jul 2023.