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Reducing Help-Seeking Stigma in Young Adults at Elevated Suicide Risk

Primary Purpose

Suicide, Help-Seeking Behavior, Health Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Bias Modification
Psychoeducation
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Florida State University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Cognitive Bias Modification for Help-Seeking Stigma (CBM-HS)

Placebo Cognitive Bias Modification

Self-Directed Psychoeducation

Arm Description

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.

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).

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).

Outcomes

Primary Outcome Measures

Perceived Stigma and Barriers to Care for Psychological Problems Scale (PS)
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.
Self-Stigma of Seeking Help (SSOSH)
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.
World Mental Health Composite International Diagnostic Interview (WMH-CIDI)
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.
Readiness to Change Scale
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.
Mental Health Treatment Survey
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.
Intervention Acceptability and Feasibility Questionnaire
An investigator-developed questionnaire will be administered to determine the acceptability and feasibility of the proposed intervention.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2018
Last Updated
August 19, 2021
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT03646903
Brief Title
Reducing Help-Seeking Stigma in Young Adults at Elevated Suicide Risk
Official Title
Reducing Help-Seeking Stigma in Young Adults at Elevated Suicide Risk: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 24, 2018 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Help-Seeking Behavior, Health Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Bias Modification for Help-Seeking Stigma (CBM-HS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Cognitive Bias Modification
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Self-Directed Psychoeducation
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Bias Modification
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
Psychoeducation-based interventions rely on the premise that enhancing knowledge about psychiatric symptoms and treatment will facilitate treatment engagement.
Primary Outcome Measure Information:
Title
Perceived Stigma and Barriers to Care for Psychological Problems Scale (PS)
Description
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.
Time Frame
2-Month Follow-Up
Title
Self-Stigma of Seeking Help (SSOSH)
Description
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.
Time Frame
2-Month Follow-Up
Title
World Mental Health Composite International Diagnostic Interview (WMH-CIDI)
Description
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.
Time Frame
2-Month Follow-Up
Title
Readiness to Change Scale
Description
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.
Time Frame
2-Month Follow-Up
Title
Mental Health Treatment Survey
Description
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.
Time Frame
2-Month Follow-Up
Title
Intervention Acceptability and Feasibility Questionnaire
Description
An investigator-developed questionnaire will be administered to determine the acceptability and feasibility of the proposed intervention.
Time Frame
2-Month Follow-Up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian H Stanley
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Reducing Help-Seeking Stigma in Young Adults at Elevated Suicide Risk

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