Military Service Members at Elevated Suicide Risk Clinical Trial
Official title:
Increasing Connection to Care Among Military Service Members at Elevated Suicide Risk: A Randomized Controlled Trial of a Web-Based Intervention
| NCT number | NCT04043936 |
| Other study ID # | 043716 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 19, 2020 |
| Est. completion date | March 31, 2023 |
| Verified date | April 2023 |
| Source | Florida State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 160 |
| Est. completion date | March 31, 2023 |
| Est. primary completion date | March 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Naval Medical Center Portsmouth | Portsmouth | Virginia |
| United States | Florida State University | Tallahassee | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Florida State University | Military Suicide Research Consortium |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 |