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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03646903
Other study ID # PRG-0-141-17
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 24, 2018
Est. completion date March 1, 2021

Study information

Verified date August 2021
Source Florida State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date March 1, 2021
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Florida State University Tallahassee Florida

Sponsors (1)

Lead Sponsor Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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