Assessing Online Interventions for Men's' Mental Health and Wellbeing
2022年1月27日 更新者：Jodi Jacobson Frey、University of Maryland, Baltimore
The purpose of this study is to test a comprehensive, male-oriented, online screening and referral (Screening for Mental Health; SMH) and male-oriented online information and referral intervention program (Man Therapy; MT) to improve mental health and wellbeing with a focus on prevention of suicide and help-seeking behaviors among middle-aged men.
The online programs will be offered together to maximize the effect on reducing suicide behavior and increasing mental health help-seeking behaviors for men.
If successful in decreasing suicide behavior and ideation and increasing suicide help-seeking behavior, this intervention could be scaled up to contribute to a reduction in suicide behaviors and deaths across the country.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
554
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Maryland
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Baltimore、Maryland、美国、21201
- University of Maryland Baltimore
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
25年 至 64年 (成人)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- men living in Michigan;
- 25-64 years of age at time of enrollment;
- scoring in the moderate- to high-risk range (or answering positively on Question 9) on the Harvard Department of Psychiatry/NDSD Scale (HANDS), scoring in the moderate- to high-risk range for anger on the DSM-5 Level 1 Cross-Cutting Symptom Measure, or identifying any risk for suicide ideation or behavior on the Columbia-Suicide Severity Rating Sale (C-SSRS); and
- fluent in reading English
Exclusion Criteria:
- females
- scoring in the low risk range on the Harvard Department of Psychiatry/NDSD Scale (HANDS), scoring in the low risk range for anger on the DSM-5 Level 1 Cross-Cutting Symptom Measure, or not identifying any risk for suicide ideation or behavior on the Columbia-Suicide Severity Rating Sale (C-SSRS); and
- not fluent in reading English
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Screening for Mental Health only
Participants in the Screening for Mental Health only (control) group will complete the online depression and suicide screening and receive immediate feedback and referrals.
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Participants in the Screening for Mental Health (SMH)-only group will complete the online depression and suicide screening and receive immediate feedback and referrals.
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实验性的：Screening for Mental Health & Man Therapy
Participants assigned to Screening for Mental Health & Man Therapy (intervention) group will be offered the Man Therapy program in conjunction with Screening for Mental Health.
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Participants assigned to Screening for Mental Health, plus Man Therapy (SMH+MT) group will be offered the Man Therapy program in conjunction with Screening for Mental Health.
MT provides online early intervention services designed specifically for men who are at risk for suicide and are less likely to engage in help-seeking behavior.
MT takes an innovative and humorous approach to mental health education and help seeking through a fictional "therapist" named Dr.
Rich Mahogany, who is a no-nonsense "man's man" who informs men about the importance of honest talk about life's challenges in addressing their problems.
The web portal allows review "manly mental health information, facts and tips," explore "man therapies," and view videos of men with lived experience.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Change in depression symptoms as measured by The HANDS: Harvard Department of Psychiatry National Depression Screening Day Scale
大体时间：Baseline; 2 weeks post randomization; 12 weeks post randomization
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Baseline; 2 weeks post randomization; 12 weeks post randomization
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Change in suicide risk as measured by the Columbia-Suicide Severity Rating Scale-Screen Version
大体时间：Baseline; 2 weeks post randomization; 12 weeks post randomization
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Baseline; 2 weeks post randomization; 12 weeks post randomization
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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change in attitudes toward help-seeking behavior as measured by the Attitudes Toward Seeking Professional Help short-form
大体时间：2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in alcohol use/abuse as measured by the Alcohol Use Disorders Identification Test
大体时间：2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in relationship conflicts as measured by the Psychological Aggression Scale
大体时间：2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in financial situation as measured by two items (J1 and J4) of the 2009 National Financial Capability Study, Financial Industry Regulatory Authority
大体时间：2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in social support as measured by the Perceived Social Support and/or Conflict scale
大体时间：2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in interpersonal needs as measured by the Interpersonal Needs Questionnaire
大体时间：2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in drug use/abuse as measured by the National Institute of Drug Abuse Quick Screen
大体时间：2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in physical aggression as measured by the Physical Aggression Index scale
大体时间：2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in help seeking behavior as measured by the Perceived Stigma and Barriers to Care for Psychological Problems scale
大体时间：2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in help seeking behavior as measured by the General Help Seeking Questionnaire
大体时间：2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in physical and mental health as measured by the Healthy Days Measures
大体时间：2 weeks post randomization; 12 weeks post randomization
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2 weeks post randomization; 12 weeks post randomization
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change in anger as measures by the DSM-5 Self Rated Level 1 Cross-Cutting Symptom Measure
大体时间：Baseline; 2 weeks post randomization; 12 weeks post randomization
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Baseline; 2 weeks post randomization; 12 weeks post randomization
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jodi Jacobson Frey、University of Maryland, Baltimore
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年9月1日
初级完成 (实际的)
2019年5月30日
研究完成 (实际的)
2020年8月31日
研究注册日期
首次提交
2016年4月6日
首先提交符合 QC 标准的
2016年5月24日
首次发布 (估计)
2016年5月27日
研究记录更新
最后更新发布 (实际的)
2022年2月10日
上次提交的符合 QC 标准的更新
2022年1月27日
最后验证
2022年1月1日
更多信息
与本研究相关的术语
其他研究编号
- HP-00066262
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Screening for Mental Health only的临床试验
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Florida State UniversityUniversity of North Carolina, Chapel Hill; University of Georgia邀请报名
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Universidad del DesarrolloSuperintendencia de Seguridad Social, Chile招聘中