Increasing Help-Seeking in Military Service Members

April 12, 2023 updated by: Thomas Joiner, Florida State University

Increasing Connection to Care Among Military Service Members at Elevated Suicide Risk: A Randomized Controlled Trial of a Web-Based Intervention

There is sufficient evidence that military service members markedly underutilize behavioral health care services, in part, due to stigma. This study proposes to examine a novel application of a cognitive bias modification (CBM) intervention designed to target stigma-related cognitions among service members at elevated suicide risk not currently engaged in behavioral health treatment.

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.

Detailed Description

This study proposes to examine a novel application of a cognitive bias modification (CBM) intervention designed to target stigma-related cognitions among service members at elevated suicide risk not currently engaged in behavioral health treatment. Interventions that leverage CBM principles involve the completion of brief, web-based tasks in which participants are presented with a series of stimuli (e.g., words, sentences) and trained to respond to those stimuli in a manner that is positive or neutral, rather than negative and unhelpful. Consistent with the theoretical rationale for Cognitive Behavioral Therapy, CBM interventions function by reshaping negative cognitions. Repeated reinforcement of adaptive cognitions enhances functioning and reduces distress. CBM interventions have efficacy in reducing maladaptive cognitions across a range of psychiatric symptoms. However, limited data exist regarding the use of CBM to target help-seeking stigma cognitions.

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.
160

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32306
        • Florida State University
    • Virginia
      • Portsmouth, Virginia, United States, 23708
        • Naval Medical Center Portsmouth

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

No

Description

Inclusion Criteria:

  • current active duty U.S. military service member
  • lifetime history of suicidal ideation per a self-report version of the SITBI-SF and/or
  • current elevated suicide risk factors (i.e., screening positive for clinically significant suicidal ideation [DSI-SS Total Score > 2], depression [PHQ-9 Total Score > 14], anxiety [GAD-7 Total Score > 9], PTSD [PCL-5 Total Score > 32], alcohol use [AUDIT-C Total Score > 3 for men and > 2 for women], and/or anger [DARS Total Score > 22])
  • no current behavioral health service use (i.e., ongoing care with a provider to receive psychiatric medications, therapy, and/or counseling)

Exclusion Criteria:

  • unable to provide informed consent
  • lack of Internet access via a computer, tablet, and/or mobile phone
  • scheduled to be stationed outside the continental U.S. any time during the 11 weeks following study enrollment (i.e., during the study period)
  • imminent suicide risk (i.e., suicide risk warranting hospitalization) based on the Joiner et al. and Chu et al. Decision Tree Framework.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial 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: 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 behavioral health services. 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. Participants in this condition will complete three separate 15-minute CBM-HS sessions.
Behavioral: Cognitive Bias Modification Intervention for Help-Seeking Stigma
Cognitive bias modification (CBM) is an intervention designed to target stigma-related cognitions among individuals at elevated suicide risk not currently engaged in behavioral health treatment. It involves the completion of brief, web-based tasks in which participants are presented with a series of stimuli (e.g., words, sentences) and trained to respond to those stimuli in a manner that is positive or neutral, rather than negative and unhelpful. Consistent with the theoretical rationale for Cognitive Behavioral Therapy, CBM interventions function by reshaping negative cognitions. Repeated reinforcement of adaptive cognitions enhances functioning and reduces distress.
Other Names:
  • CBM-HS
Sham Comparator: Placebo Cognitive Bias Modification
Participants randomized to this condition will complete a CBM task with a 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: Placebo Cognitive Bias Modification (CBM-Placebo)
Cognitive bias modification (CBM) is an intervention designed to target stigma-related cognitions among individuals at elevated suicide risk not currently engaged in behavioral health treatment. It involves the completion of brief, web-based tasks in which participants are presented with a series of stimuli (e.g., words, sentences) and trained to respond to those stimuli in a manner that is positive or neutral, rather than negative and unhelpful. Consistent with the theoretical rationale for Cognitive Behavioral Therapy, CBM interventions function by reshaping negative cognitions. Repeated reinforcement of adaptive cognitions enhances functioning and reduces 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 will be comparable to the duration of study tasks for individuals in the CBM-HS study condition (i.e., three 15-minute sessions).
Behavioral: Self-Directed Psychoeducation
Material presented with information on mental health literacy, mental health stigma, & treatment options. This is based on the idea that increasing knowledge about psychiatric symptoms and treatment options encourages help-seeking behavior and engagement.

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
Perceived Stigma and Barriers to Care for Psychological Problems Scale (PS)
Time Frame: 2-Month Follow-up
The 11-item 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; higher scores (range: 11-55) indicate greater perceived barriers to care. The PS has been used extensively in military populations and has exhibited acceptable to good internal consistency.
2-Month Follow-up
Readiness to Change
Time Frame: 2-Month Follow-up
Consistent with past research, we will use an adaptation of the Readiness to Change Scale to 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 (range: 0-60) indicating greater readiness to engage in behavioral health care. Past research using this approach has yielded good internal consistency.
2-Month Follow-up
Self-Stigma of Seeking Help (SSOSH)
Time Frame: 2-Month Follow-up
The 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 associated with seeking help. The scale has demonstrated strong reliability and validity, and it differentiates between young adults who do and do not seek help for mental health problems.
2-Month Follow-up
World Mental Health Composite International Diagnostic Interview (WMH-CIDI)
Time Frame: 2-Month Follow-up
A self-report version of the WMH-CIDI Services subscale will be utilized to assess the presence/absence of specific structural and attitudinal barriers to care. This WMH-CIDI has been used extensively among adult community samples, including among individuals at elevated suicide risk.
2-Month Follow-up
Client Satisfaction Questionnaire-8 (CSQ-8)
Time Frame: 2-Month Follow-up
The CSQ-8 is an 8-item self-report measure that assesses client satisfaction with services, including mental health care services (range: 8-32). The CSQ-8 has demonstrated strong psychometric properties, including among psychotherapy patients.
2-Month Follow-up
Intervention Acceptability and Feasibility Questionnaire
Time Frame: 2-Month Follow-up
Acceptability and feasibility will be measured using recruitment and retention rates and open-ended treatment satisfaction questions administered to participants at post-treatment (e.g., "What aspects of the intervention could be improved?").
2-Month Follow-up

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.
Florida State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Military Suicide Research Consortium

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.
April 19, 2020

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 31, 2023

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 31, 2023

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).
August 1, 2019

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.
August 1, 2019

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.
August 2, 2019

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.
April 13, 2023

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.
April 12, 2023

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.
April 1, 2023

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.
  • 043716

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.

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