Increasing Help-Seeking in Military Service Members

NCT04043936 | Completed DMC

• 1 other identifier: 043716
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Military Service Members at Elevated Suicide Risk

Keywords

suicide prevention; reducing stigma

Outcome Measures

Primary Outcomes (6)

• 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.

  2-Month Follow-up

• 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.

  2-Month Follow-up

• 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.

  2-Month Follow-up

• 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.

  2-Month Follow-up

• 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.

  2-Month Follow-up

• 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?").

  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 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

Placebo Cognitive Bias Modification

SHAM COMPARATOR

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)

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 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

Interventions

Cognitive Bias Modification Intervention for Help-Seeking Stigma BEHAVIORAL

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.

Also known as: CBM-HS

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

Placebo Cognitive Bias Modification (CBM-Placebo) BEHAVIORAL

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.

Placebo Cognitive Bias Modification

Self-Directed Psychoeducation BEHAVIORAL

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.

Self-Directed Psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida State University: lead
• Military Suicide Research Consortium: collaborator

Study Sites (2)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Naval Medical Center Portsmouth

Portsmouth, Virginia, 23708, United States

Location

MeSH Terms

Conditions

Suicide Prevention

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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).
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Robert O. Lawton Professor in the Department of Psychology

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 2, 2019
• Study Start: April 19, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)