Back to resultsIncreasing Help-Seeking in Military Service Members
Primary Purpose
Military Service Members at Elevated Suicide Risk
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Bias Modification Intervention for Help-Seeking Stigma
Placebo Cognitive Bias Modification (CBM-Placebo)
Self-Directed Psychoeducation
Sponsored by
About this trial
This is an interventional health services research trial for Military Service Members at Elevated Suicide Risk focused on measuring suicide prevention, reducing stigma
Eligibility Criteria
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.
Sites / Locations
- Florida State University
- Naval Medical Center Portsmouth
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham 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 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.
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).
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).
Outcomes
Primary Outcome Measures
Perceived Stigma and Barriers to Care for Psychological Problems Scale (PS)
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.
Readiness to Change
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.
Self-Stigma of Seeking Help (SSOSH)
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.
World Mental Health Composite International Diagnostic Interview (WMH-CIDI)
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.
Client Satisfaction Questionnaire-8 (CSQ-8)
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.
Intervention Acceptability and Feasibility Questionnaire
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?").
Secondary Outcome Measures
Full Information
NCT ID
NCT04043936
First Posted
August 1, 2019
Last Updated
April 12, 2023
Sponsor
Florida State University
Collaborators
Military Suicide Research Consortium
1. Study Identification
Unique Protocol Identification Number
NCT04043936
Brief Title
Increasing Help-Seeking in Military Service Members
Official Title
Increasing Connection to Care Among Military Service Members at Elevated Suicide Risk: A Randomized Controlled Trial of a Web-Based Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 19, 2020 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
Military Suicide Research Consortium
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Military Service Members at Elevated Suicide Risk
Keywords
suicide prevention, reducing stigma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Participants will be placed in one of three groups (Cognitive Bias Modification Intervention for Help-Seeking Stigma (CBM-HS) condition, the Cognitive Bias Modification (CBM-Placebo) condition, or the Self-Directed Psychoeducation condition [comparison condition]). Participants will then complete 5 additional virtual study visits (3 intervention weeks, 1 post-treatment, 1 two-month follow-up); these study visits will occur through a web-based platform. Self-report measures will be administered at enrollment/baseline, mid-intervention, post-intervention, and two-month follow-up.
Masking
Participant
Masking Description
Participant will be in the Cognitive Bias Modification Intervention for Help-Seeking Stigma (CBM-HS) condition (intervention condition), the Cognitive Bias Modification (CBM-Placebo) condition (placebo condition), or the Self-Directed Psychoeducation condition (comparison condition).
Allocation
Randomized
Enrollment
160 (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 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.
Arm Title
Placebo Cognitive Bias Modification
Arm Type
Sham Comparator
Arm Description
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).
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 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 for Help-Seeking Stigma
Other Intervention Name(s)
CBM-HS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Placebo Cognitive Bias Modification (CBM-Placebo)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-Directed Psychoeducation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Perceived Stigma and Barriers to Care for Psychological Problems Scale (PS)
Description
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.
Time Frame
2-Month Follow-up
Title
Readiness to Change
Description
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.
Time Frame
2-Month Follow-up
Title
Self-Stigma of Seeking Help (SSOSH)
Description
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.
Time Frame
2-Month Follow-up
Title
World Mental Health Composite International Diagnostic Interview (WMH-CIDI)
Description
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.
Time Frame
2-Month Follow-up
Title
Client Satisfaction Questionnaire-8 (CSQ-8)
Description
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.
Time Frame
2-Month Follow-up
Title
Intervention Acceptability and Feasibility Questionnaire
Description
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?").
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 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.
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States
Facility Name
Naval Medical Center Portsmouth
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23708
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Increasing Help-Seeking in Military Service Members
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