Increasing Help-Seeking in Military Service Members

NCT ID: NCT04043936

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-19
• Study Completion Date: 2023-03-31

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.

Conditions

Military Service Members at Elevated Suicide Risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Bias Modification Intervention for Help-Seeking Stigma

Intervention Type: 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

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).

Group Type: SHAM_COMPARATOR

Placebo Cognitive Bias Modification (CBM-Placebo)

Intervention Type: 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.

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).

Group Type: ACTIVE_COMPARATOR

Self-Directed Psychoeducation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CBM-HS

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Military Suicide Research Consortium

OTHER

Sponsor Role: collaborator

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Thomas Joiner

The Robert O. Lawton Professor in the Department of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Florida State University

Tallahassee, Florida, United States

Naval Medical Center Portsmouth

Portsmouth, Virginia, United States

Countries

United States

Other Identifiers

043716

Identifier Type: -

Identifier Source: org_study_id