NCT03646903

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 24, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

1.7 years

First QC Date

August 23, 2018

Last Update Submit

August 19, 2021

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    2-Month Follow-Up

  • 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.

    2-Month Follow-Up

  • 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.

    2-Month Follow-Up

  • 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.

    2-Month Follow-Up

  • 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.

    2-Month Follow-Up

  • Intervention Acceptability and Feasibility Questionnaire

    An investigator-developed questionnaire will be administered to determine the acceptability and feasibility of the proposed intervention.

    2-Month Follow-Up

Study Arms (3)

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

EXPERIMENTAL

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.

Behavioral: Cognitive Bias Modification

Placebo Cognitive Bias Modification

PLACEBO COMPARATOR

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).

Behavioral: Cognitive Bias Modification

Self-Directed Psychoeducation

ACTIVE COMPARATOR

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).

Behavioral: Psychoeducation

Interventions

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.

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

Psychoeducation-based interventions rely on the premise that enhancing knowledge about psychiatric symptoms and treatment will facilitate treatment engagement.

Self-Directed Psychoeducation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

SuicideHelp-Seeking BehaviorHealth Behavior

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Ian H Stanley

    Florida State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Faculty

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 24, 2018

Study Start

September 24, 2018

Primary Completion

June 1, 2020

Study Completion

March 1, 2021

Last Updated

August 23, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations