NCT05458830

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
775

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 7, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

July 12, 2022

Last Update Submit

July 12, 2023

Conditions

Keywords

Barrier reduction interventionSuicidal ideationSelf-helpSuicide prevention helplineRandomised controlled trialHelp-seeking

Outcome Measures

Primary Outcomes (1)

  • 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).

    immediately after intervention

Secondary Outcomes (1)

  • Self-reported likelihood of contacting the helpline

    immediately after intervention

Other Outcomes (5)

  • Severity of suicidal thoughts: Suicidal Ideation Attributes Scale (SIDAS)

    Baseline measurement

  • Gender

    Baseline measurement

  • Age group

    Baseline measurement

  • +2 more other outcomes

Study Arms (2)

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.

Behavioral: Brief Barrier Reduction Intervention

Care as usual

OTHER

Plain advisory text

Behavioral: Plain advisory text

Interventions

After selecting a barrier in the barrier survey, participants receive tailored information with the purpose of addressing common concerns and misconceptions about the helpline.

Intervention

Care as usual

Also known as: care as usual
Care as usual

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

113 Suicide Prevention

Amsterdam, Netherlands

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Saskia Mérelle

    113 Suicide Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 14, 2022

Study Start

October 7, 2022

Primary Completion

December 5, 2022

Study Completion

April 1, 2023

Last Updated

July 13, 2023

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

The data will be made available upon request

Locations