- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03646903
Reducing Help-Seeking Stigma in Young Adults at Elevated Suicide Risk
August 19, 2021 updated by: Ian Stanley, Florida State University
Reducing Help-Seeking Stigma in Young Adults at Elevated Suicide Risk: A Randomized Controlled Trial
Although there exist interventions that therapeutically impact suicide risk, the connection of individuals at elevated suicide risk to mental health care services remains an ongoing challenge.
One persistent barrier to mental health service utilization is help-seeking stigma-that is, having negative beliefs about the implications of seeking help for mental health problems (e.g., "Seeking help means that I am weak").
Thus, to enhance mental health service use among at-risk individuals, efforts are needed to target help-seeking stigma.
Preliminary data from our research group indicate that a novel computerized intervention based on cognitive therapy principles can demonstrably reduce help-seeking stigma and increase connection to care among young adults with untreated psychiatric disorders.
However, this intervention has not been tested among individuals who are currently experiencing suicidal ideation and are not engaged in mental health treatment.
Testing the efficacy of this computerized intervention among young adults at increased risk for suicide is necessary to address the unique challenge of linking at-risk individuals to potentially life-saving treatments.
To this end, this study aims to test the efficacy of a brief web-based intervention, cognitive bias modification for help-seeking stigma (CBM-HS), designed to increase mental health help-seeking intentions and behaviors.
A total of 78 young adults with current suicidal ideation who are not currently in treatment and who report elevated levels of help-seeking stigma will be randomly assigned to one of three conditions: (1) CBM-HS; (2) CBM-Placebo (i.e., a sham CBM condition analogous to a placebo pill in a pharmaceutical trial); or (3) psychoeducation.
Participants will complete assessments at baseline, mid-intervention, post-intervention, and 2-month follow-up to determine the efficacy of CBM-HS in: (a) modifying stigma-related cognitions around mental health help-seeking and service use and (b) increasing treatment initiation and engagement.
Moreover, we will test if reductions in stigma-related cognitions mediate the relationship between study condition and subsequent help-seeking behaviors.
Findings from the proposed pilot randomized controlled trial have the potential to enhance connection to care among young adults at elevated suicide risk.
Importantly, the brief, web-based nature of the intervention enhances its acceptability, feasibility, and scalability.
Should CBM-HS demonstrate efficacy in reducing help-seeking stigma and enhancing connection to care among at-risk individuals, it has the potential to serve as a useful tool in suicide prevention efforts.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- 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
-
-
Florida
-
Tallahassee, Florida, United States, 32306
- Florida State 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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Current undergraduate student
- Current suicidal ideation (DSI-SS Total Score >0)
- Elevated help-seeking stigma (SSOSH Total Score >24)
- No current mental health service use (i.e., ongoing care with a provider to receive psychiatric medications, therapy, and/or counseling)
Exclusion Criteria:
- Lack of Internet access via a privately-located laptop or desktop computer
- Completing last semester of undergraduate coursework
- Imminent suicide risk (i.e., suicide risk warranting hospitalization)
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Bias Modification for Help-Seeking Stigma (CBM-HS)
CBM-HS is a 15-minute web-based intervention designed to alter maladaptive cognitions related to mental health help-seeking.
In this task, individuals are presented with a series of statements regarding beliefs about using mental health services (e.g., "Seeking help for my problems means I am weak").
Individuals then select "True" or "False" in response to each statement.
Incorrect responses (i.e., demonstrating help-seeking stigma) are followed by corrective feedback.
Conversely, correct responses (i.e., promoting help-seeking) are positively reinforced (e.g., "That's right!
You are correct!").
Participants in this condition will complete three separate 15-minute CBM-HS sessions.
|
Cognitive bias modification (CBM) interventions typically involve the completion of brief, web-based tasks in which individuals are presented with a series of stimuli (e.g., words, sentences) and trained to respond in a manner that is positive or neutral, rather than negative and unhelpful.
CBM interventions rely on the premise that repeated reinforcement of adaptive cognitions and a reshaping of negative cognitions enhance functioning and reduce distress.
|
Placebo Comparator: Placebo Cognitive Bias Modification
Participants randomized to this condition will complete a similar CBM task with neutral stimuli.
The duration of the CBM-Placebo task will be comparable to the duration of the CBM-HS task (i.e., three 15-minute sessions).
|
Cognitive bias modification (CBM) interventions typically involve the completion of brief, web-based tasks in which individuals are presented with a series of stimuli (e.g., words, sentences) and trained to respond in a manner that is positive or neutral, rather than negative and unhelpful.
CBM interventions rely on the premise that repeated reinforcement of adaptive cognitions and a reshaping of negative cognitions enhance functioning and reduce distress.
|
Active Comparator: Self-Directed Psychoeducation
Participants randomized to this condition will review psychoeducation on mental health literacy, mental illness stigma, and treatment options.
Readings will be compiled from resources available in the public domain.
The duration of self-directed psychoeducation will be comparable to the duration of study tasks for individuals in the CBM-HS study condition (i.e., three 15-minute sessions).
|
Psychoeducation-based interventions rely on the premise that enhancing knowledge about psychiatric symptoms and treatment will facilitate treatment engagement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stigma and Barriers to Care for Psychological Problems Scale (PS)
Time Frame: 2-Month Follow-Up
|
The 11-item Perceived Stigma and Barriers to Care for Psychological Problems Scale (PS) measures the extent to which various concerns might affect an individual's decision to seek psychiatric treatment.
Items are rated on a 5-point scale; scores are summed and higher scores (range: 11-55) indicate greater perceived barriers to care.
Individual PS items will also be evaluated consistent with past research.
|
2-Month Follow-Up
|
Self-Stigma of Seeking Help (SSOSH)
Time Frame: 2-Month Follow-Up
|
The Self-Stigma of Seeking Help (SSOSH) is a 10-item measure of help-seeking stigma.
Responses are rated on a 5-point scale; higher scores (range: 0-50) reflect greater self-stigma.
|
2-Month Follow-Up
|
World Mental Health Composite International Diagnostic Interview (WMH-CIDI)
Time Frame: 2-Month Follow-Up
|
The self-report version of the World Mental Health Composite International Diagnostic Interview (WMH-CIDI) Services subscale will be utilized to assess structural and attitudinal barriers to care.
Items are evaluated individually and higher scores indicate greater structural and attitudinal barriers to care.
|
2-Month Follow-Up
|
Readiness to Change Scale
Time Frame: 2-Month Follow-Up
|
An adaptation of the Readiness to Change Scale will assess readiness to engage in help-seeking behaviors.
Responses to each of the 6 items are anchored on an 11-point scale, with higher scores indicating greater readiness to engage in mental health treatment.
|
2-Month Follow-Up
|
Mental Health Treatment Survey
Time Frame: 2-Month Follow-Up
|
An adapted version of SAMHSA's National Survey on Drug Use and Health (NSDUH) will be used to assess help-seeking behaviors and mental health service use for general mental health problems and/or suicide-related reasons, specifically.
|
2-Month Follow-Up
|
Intervention Acceptability and Feasibility Questionnaire
Time Frame: 2-Month Follow-Up
|
An investigator-developed questionnaire will be administered to determine the acceptability and feasibility of the proposed intervention.
|
2-Month Follow-Up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ian H Stanley, Florida State University
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)
September 24, 2018
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
March 1, 2021
Study Registration Dates
First Submitted
August 23, 2018
First Submitted That Met QC Criteria
August 23, 2018
First Posted (Actual)
August 24, 2018
Study Record Updates
Last Update Posted (Actual)
August 23, 2021
Last Update Submitted That Met QC Criteria
August 19, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRG-0-141-17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on Suicide
-
Syeda AYAT E ZAINAB AliUniversity of Leicester; University of WuerzburgRecruitingSuicide, Attempted | Suicide | Suicide Prevention | Completed SuicidePakistan
-
Seattle Children's HospitalNationwide Children's HospitalRecruitingSuicidal Ideation | Suicide Threat | Suicide and Self-harm | Suicide AttemptsUnited States
-
Vestre Viken Hospital TrustSouth-Eastern Norway Regional Health AuthorityRecruitingEcological Momentary Assessment | Suicide Risk | Suicide Attempt | Suicide Ideation | Suicide PreventionNorway
-
Mental Health Services in the Capital Region, DenmarkCompletedSuicide Prevention | Suicidal Thoughts | Suicide AttemptsDenmark
-
Franciscan Hospital For Children, INC.National Institute of Mental Health (NIMH); Harvard UniversityRecruitingSuicidal Ideation | Self-Injurious Behavior | Suicide AttemptsUnited States
-
Boston UniversityUnited States Department of Defense; The University of Texas Health Science... and other collaboratorsNot yet recruiting
-
Kaiser PermanenteNational Institute of Mental Health (NIMH); Henry Ford Health System; HealthPartners...Enrolling by invitationSuicide, Attempted | Suicide, FatalUnited States
-
University Hospital, MontpellierINSERM U960 - Cognitive Neuroscience Laboratory - Paris, FranceTerminatedDepression | History of Suicide AttemptFrance
-
University Hospital, RouenInstitut National de la Santé Et de la Recherche Médicale, FranceCompleted
Clinical Trials on Cognitive Bias Modification
-
Istanbul Sabahattin Zaim UniversityCompletedPerfectionism | Intolerance to UncertaintyUnited States
-
Temple UniversityNot yet recruiting
-
Universidad Complutense de MadridCompletedDepression | Cognitive ChangeSpain
-
Ryerson UniversityMinistry of Research, Innovation and Science, OntarioSuspended
-
Centre for Addiction and Mental HealthAmerican Foundation for Suicide PreventionCompletedSubstance DependenceCanada
-
King's College LondonSouth London and Maudsley NHS Foundation Trust; South West London and St George... and other collaboratorsUnknownEating Disorders in AdolescenceUnited Kingdom
-
University of SouthamptonEconomic and Social Research Council, United KingdomCompletedChronic Pain | Musculoskeletal Pain DisorderUnited Kingdom
-
Dokuz Eylul UniversityThe Scientific and Technological Research Council of TurkeyCompletedObsessive-compulsive Disorders and Symptoms | Obsessive Thoughts | Obsessive Compulsive BehaviorTurkey
-
Ruhr University of BochumUniversity Hospital, EssenRecruiting
-
Mclean HospitalRecruitingObsessive-Compulsive DisorderUnited States