Beneficial and Harmful Effects of Reducing Public Suicide Stigma

June 9, 2021 updated by: Nathalie Oexle, University of Ulm
There is growing evidence that negative attitudes towards persons affected by suicide (i.e. persons who experience suicidality, persons who lost a loved one to suicide), so called public suicide stigma, is harmful for suicide prevention, for example by reducing social support, inhibiting help-seeking for suicidality and increasing distress as well as suicidality among stigmatized persons. Reducing public suicide stigma could therefore be an important factor of successful suicide prevention. However, reducing public suicide stigma could also be harmful, for example by increasing attitudes that suicidal behaviour is a normal and acceptable solution for crisis situations, which could decrease help-seeking for suicidality and encourage suicidal behaviour. This project will (1) develop four interventions (contact-based vs. education based, video vs. text) hypothesized to reduce public suicide stigma, (2) determine the efficacy of the four interventions with regard to reducing public suicide stigma, (3) identify additional harmful (e.g. normalization of suicidal behaviour) and beneficial intervention effects (e.g. improved attitudes to seek help) and (4) investigate pathways explaining intervention effects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ulm, Germany, 89075
        • Ulm University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participants need to be at least 18 years old, speak German and provide online informed consent.

Exclusion Criteria:

Persons who self-report to have experienced suicidality within three months before baseline will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Contact Video
Participants randomized to this group will watch a video of a person talking about his recovery after attempting suicide.
Other: Contact Video
No additional information necessary.
Experimental: Contact Text
Participants randomized to this group will read a personal story of a person who survived a suicide attempt.
Other: Contact Text
No additional information necessary.
Experimental: Education Video
Participants randomized to this group will watch a video of a psychiatrist presenting facts about suicide and suicide prevention.
Other: Education Video
No additional information necessary.
Experimental: Education Text
Participants randomized to this group will read a text containing facts about suicide and suicide prevention.
Other: Education Text
No additional information necessary.
Placebo Comparator: Control Contact
Participants randomized to this group will read a personal story of a person who survived a heart attack.
Other: Contact Video
No additional information necessary.
Other: Contact Text
No additional information necessary.
Placebo Comparator: Control Education
Participants randomized to this group will read a text containing facts about heart-attacks and their prevention.
Other: Education Video
No additional information necessary.
Other: Education Text
No additional information necessary.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stigma subscale of the Stigma of Suicide Scale short form (SOSS-SF)
Time Frame: Immediately after the intervention (t1)
Batterham al. (2013) The Stigma of Suicide Scale. Psychometric properties and correlates of the stigma of suicide. Crisis 34(1):13-21
Immediately after the intervention (t1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stigma subscale of the Stigma of Suicide Scale short form (SOSS-SF)
Time Frame: Two weeks after the intervention (t2)
Batterham al. (2013) The Stigma of Suicide Scale. Psychometric properties and correlates of the stigma of suicide. Crisis 34(1):13-21
Two weeks after the intervention (t2)
Literacy of Suicide Scale (LOSS)
Time Frame: Immediately after the intervention (t1); Two weeks after the intervention (t2)
Batterham et al. (2013) Correlates of suicide stigma and suicide literacy in the community. Suicide Life Threat Behav 43(4):406-417
Immediately after the intervention (t1); Two weeks after the intervention (t2)
Cognitions Concerning Suicide Scale (CCSS)
Time Frame: Immediately after the intervention (t1); Two weeks after the intervention (t2)
Cwik et al. (2017) Measuring attitudes towards suicide: Preliminary evaluation of an attitude towards suicide scale. Compr Psychiatry 72:56-65
Immediately after the intervention (t1); Two weeks after the intervention (t2)
General help-seeking questionnaire suicidal ideation subscale (GHSQ-SI)
Time Frame: Immediately after the intervention (t1); Two weeks after the intervention (t2)
Wilson et al. (2005) Measuring help-seeking intentions: Properties of the General Help-Seeking Questionnaire. Canadian Journal of Counselling 39(1):15-28
Immediately after the intervention (t1); Two weeks after the intervention (t2)
Current suicidality
Time Frame: Immediately after the intervention (t1); Two weeks after the intervention (t2)
One item adapted from the PHQ-9 (Kroenke et al. 2001; "Do you currently experience thoughts that you would be better off dead or of hurting yourself?" response scale from 1 (not at all) to 7 (very much)
Immediately after the intervention (t1); Two weeks after the intervention (t2)
Positive and Negative Affect Schedule (PANAS), negative affect subscale
Time Frame: Immediately after the intervention (t1); Two weeks after the intervention (t2)
Breyer & Bluemke (2016) Deutsche Version der Positive and Negative Affect Schedule PANAS (GESIS Panel). ZIS - GESIS Leibniz Institute for the Social Sciences
Immediately after the intervention (t1); Two weeks after the intervention (t2)
Patient Health Questionnaire (PHQ-2)
Time Frame: Two weeks after the intervention (t2)
Löwe et al. (2005) Detecting and monitoring depression with a two-item questionnaire (PHQ-2). Journal of Psychosomatic Research 58(2):163-171
Two weeks after the intervention (t2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Ulm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 19, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 19, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 352/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Anonymized data available upon personal request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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