Clinical trial NCT04043936: 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
Overall status: COMPLETED
Phase: NA
Conditions: Military Service Members at Elevated Suicide Risk
Keywords: suicide prevention
reducing stigma
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: Military Suicide Research Consortium
First posted: 2019-08-02
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Perceived Stigma and Barriers to Care for Psychological Problems Scale (PS)
timeFrame: 2-Month Follow-up
measure: Readiness to Change
timeFrame: 2-Month Follow-up
measure: Self-Stigma of Seeking Help (SSOSH)
timeFrame: 2-Month Follow-up
measure: World Mental Health Composite International Diagnostic Interview (WMH-CIDI)
timeFrame: 2-Month Follow-up
measure: Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: 2-Month Follow-up
measure: Intervention Acceptability and Feasibility Questionnaire
timeFrame: 2-Month Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
Study officials:
References: