NCT06130943

Brief Summary

This study adds to the existing evidence on suicide prevention helpline efficacy because it tackles some of the common limitations for helpline studies. High risk individuals were not excluded from the study, since there was no human interference in deciding if the study was offered to the lifeline callers. Most of the existing studies exclude users in high risk and acute crisis situations. The study employed the callers' own ratings on a set of questions, automatically offered within the phone system immediately before and after the call to assess the immediate impact of the call and the intervention. The automatization of the self-report measures in the telephone system reduces the burden on the operators to offer the research questions without interrupting the crisis intervention and decreases the risk of bias in caller responses. The goal of this observational study is to evaluatie the Flesmish suicide prevention helpline in people who call the helpline when feeling suicidal. The main questions it aims to answer are:

  1. 1.Has the degree to which the caller feels in crisis subsided? (Crisis in this is seen as the subjective feeling of complete emotional upset)
  2. 2.Does the caller report feeling less suicidal? (Score on selected indicators of suicidality, particularly hopelessness, entrapment, controllability, suicidal intent and social support)
  3. 3.Is the caller satisfied with the conversation?
  4. 4.Which elements in the conversation (i.e., responders' interventions) make it more or less effective, in terms of crisis level, suicidality (indicators) and caller satisfaction?
  5. 5.Which elements of the conversation do callers name as (not) helpful during the follow-up conversation? Which elements promoted progress in this, besides merely lowering the crisis level?
  6. 6.What possible (follow-up) actions do callers see as helping to sustain and/or improve the longer-term impact of the conversation with the suicide prevention helpline?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
608

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

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

Study Start

First participant enrolled

October 12, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

November 8, 2023

Last Update Submit

November 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Indicatorts of crisis and suicidality

    Since there is no common standardized set of measures for suicide prevention helplines (Mazzer et al., 2021; Trail et al., 2022) six indicators of suicidal ideation and behaviour (SIB) are used to evaluate the calls of the Flemish Suicide Prevention Helpline. The selection of the indicators is based on previous research on helpline efficacy (Gould et al., 2007; Hoffberg et al., 2020; Hvidt et al., 2016; Kalafat et al., 2007), and on a number of core elements identified in suicide prevention theories explaining the transition from suicidal ideation to suicidal behaviour. The six indicators are crisis, hopelessness, entrapment, controllability, suicidal intent, and social support. All indicators are scored by the callers on a 10-point Likert scale (using the telephone keypad), ranging from 0 (not at all) to 9 (totally).

    Baseline, post (immediately after the call), follow-up (one to two weeks after the call)

Secondary Outcomes (1)

  • Satisfaction with the service

    Post (immediately after the call), follow-up (one to two weeks after the call)

Other Outcomes (1)

  • Follow-up interview

    Follow-up (one to two weeks after the call)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All callers who contact the suicide prevention helpline are asked to participate in the study.

You may qualify if:

  • being 18 years of age or older
  • Dutch-speaking
  • calling to the Flemish suicide prevention helpline because they felt suicidal
  • Only callers for whom it is certain that they will be connected to the Flemish suicide prevention helpline will be asked to participate.

You may not qualify if:

  • Third party callers were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Suicide Prevention

Brussels, Belgium

Location

MeSH Terms

Conditions

Suicide PreventionSuicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 14, 2023

Study Start

October 12, 2020

Primary Completion

December 4, 2021

Study Completion

December 14, 2021

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations