跳至主要内容
临床试验/NCT04043936
NCT04043936已完成不适用

Increasing Connection to Care Among Military Service Members at Elevated Suicide Risk: A Randomized Controlled Trial of a Web-Based Intervention

Florida State University2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年4月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
160
试验地点
2
主要终点
Readiness to Change

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
Single (Participant)

盲法说明

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).

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Cognitive Bias Modification Intervention for Help-Seeking Stigma (Behavioral)

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).

干预措施: Placebo Cognitive Bias Modification (CBM-Placebo) (Behavioral)

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).

干预措施: Self-Directed Psychoeducation (Behavioral)

结局指标

主要结局

Readiness to Change

时间窗: 2-Month Follow-up

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)

时间窗: 2-Month Follow-up

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.

Perceived Stigma and Barriers to Care for Psychological Problems Scale (PS)

时间窗: 2-Month Follow-up

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.

Client Satisfaction Questionnaire-8 (CSQ-8)

时间窗: 2-Month Follow-up

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.

World Mental Health Composite International Diagnostic Interview (WMH-CIDI)

时间窗: 2-Month Follow-up

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.

Intervention Acceptability and Feasibility Questionnaire

时间窗: 2-Month Follow-up

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?").

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Joiner

The Robert O. Lawton Professor in the Department of Psychology

Florida State University

研究点 (2)

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