CONSCIOUS: A Pilot Trial of a Media Orientation Intervention to Encourage Men's Help Seeking for Mental Health Difficulties (CONSCIOUS)
2026年5月30日 更新者：Tarela Ike、Teesside University
Media Orientation to Prevent Suicidal Ideation and Self Harm and Improve Help Seeking Behaviour: A Pilot Randomised Controlled Trial
Mental health difficulties among males are an issue of public health concern.
Men are also at higher risk of suicidal ideation and self-harm and are poor at help-seeking due to factors including stigma, cultural norms and gendered expectations of masculinity.
Yet, in Nigeria, a significant gap remains in media orientation intervention to create awareness on symptoms of mental health difficulties and support channels to encourage help-seeking.
In essence, the current study aims to test the feasibility and acceptability of a novel intervention titled, psyChosOcial media awareNesS for SuiCIde symptoms, including other mental health PrOblems and help seeking mediUmS (CONSCIOUS) for addressing awareness of mental health difficulties in comparison to the waitlist control group for the purposes of improving men's help seeking, social support and reducing anxiety in Nigeria.
研究概览
研究类型
介入性
注册 (估计的)
74
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。
学习联系方式
- 姓名：Tarela J Ike, PhD
- 电话号码：0164234231
- 邮箱：T.ike@tees.ac.uk
研究联系人备份
- 姓名：Dung E Jidong, PhD
- 邮箱：Dung.jidong@manchester.ac.uk
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
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- male, aged 18 years or above, able to provide full informed consent to aid their participation, able to speak the English language which is Nigeria language. able to take part in the intervention and are available for the intervention assessment at baseline and end of intervention.
Exclusion Criteria:
- less than 18 years old, unable to provide informed consent, undergoing severe mental health treatment and unable to speak the English language. Participants were also excluded if they are high risk social ideation or self-harm patients.
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Experimental : psyChosOcial media awareNesS for SuiCIde symptoms and other mental health PrOblems
Low intensity media campaign intervention
|
The CONSCIOUS is 3 minutes recorded media message.
The intervention is designed to promote awareness on how to prevent suicidal ideation and self-harm, stigma reduction and avenues or mediums for help-seeking.
The core message is composed of three key ambits: 1) emphasizing what is meant by suicidal ideation and self-harm (ii) the need to seek help and stop societal stigmatising behaviour (iii) Avenues for help seeking and improved mental health and wellbeing.
|
|
其他：Control - Intervention as Usual/Waitlist
Intervention as Usual / Waitlist to be administered the CONSCIOUS intervention after assessment at baseline (day 1) and end of intervention (day 2).
|
Current available interventions to foster help seeking including leaflets, community health centre provision of information etc.
This group will be later offered the CONSCIOUS intervention after completion of baseline and end of intervention assessment.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Service Satisfaction Scale
大体时间：Immediately after the end of the intervention
|
A five item scale that can be used to assess and measure satisfaction, acceptability and quality of the intervention.
Higher score denote positive outcomes and acceptability.
Lower score denotes poor satisfaction and acceptability.
|
Immediately after the end of the intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
广泛性焦虑症 (GAD-7)
大体时间：基线（第1天）和干预结束时（第2天）
|
GAD-7是一个包含七个项目的量表，用于筛查、测量和评估广泛性焦虑障碍的严重程度。分数5、10和15分别被视为轻度、中度和重度焦虑的临界点。
|
基线（第1天）和干预结束时（第2天）
|
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奥斯陆社会支持量表 (OSSS-3)
大体时间：基线（第1天）和干预结束时（第2天）
|
该量表是一个包含3个项目的自评测量工具，旨在评估和衡量社会支持水平。
总分范围从3到14分，高分表示社会支持水平较高，低分表示社会支持水平较差，具体如下：a) 3-8分表示社会支持较差，b) 9-11分表示社会支持中等，c) 12-14分表示社会支持较强。
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基线（第1天）和干预结束时（第2天）
|
|
欧洲生活质量量表 EQ-5D-5L
大体时间：基线（第1天）和干预结束时（第2天）
|
EQ-5D-5L是一种包含5个项目的量表，旨在帮助评估通用生活质量。
在EQ-5D-5L中，每个维度有五个响应级别：无问题（级别1）；轻微（级别2）；中等（级别3）；严重（级别4）；和极端问题（级别5）。
通过组合每个维度的一个级别，可以定义3,125种可能的健康状况，范围从11111（完全健康）到55555（最差健康）。
|
基线（第1天）和干预结束时（第2天）
|
|
Attitude Towards Seeking Professional Psychological Help Scale
大体时间：Baseline (day 1) and at the end of intervention (day 2)
|
The ATSPPH is a 10-item scale that measures attitude towards seeking professional psychological help.
Higher scores reflect increased positive attitude towards seeking professional psychological help while lower score reflects reduced attitude towards seeking help.
|
Baseline (day 1) and at the end of intervention (day 2)
|
|
General Help Seeking Questionnaire (GHSQ)
大体时间：Baseline (day 1) and at the end of intervention (day 2)
|
The GHSQ is a 20-item scale measuring the likelihood of seeking help from a range of sources.
The scale adopts a Likert style rating as follows: Extremely unlikely(1), Somewhat unlikely (2), Unlikely (3), Not sure (4), Likely =5, Somewhat likely = 6, Extremely likely =7.
The scores are summed across all help-seeking items.
For a standard 9-item list, total scores range from 9 to 63 points.
Higher total scores indicate a greater overall intention to seek help from someone.
|
Baseline (day 1) and at the end of intervention (day 2)
|
|
Self Stigma and Help Seeking (SSHS) Scale
大体时间：Baseline (day 1) and at the end of intervention (day 2)
|
The self-stigma and help seeking scale is a 10-item scale that measures stigma of seeking help.
The scale features 10 items, each rated on a 5-point Likert scale ranging from 1 = Strongly Disagree to 5 = Strongly.
Items 2, 4, 5, 7, and 9 are reverse-scored.
The possible total score ranges from 10 to 50.
Higher total scores indicate higher levels of internalised self-stigma associated with seeking professional psychological help.
|
Baseline (day 1) and at the end of intervention (day 2)
|
|
Stigma of Suicide Scale (SOSS)
大体时间：Baseline (day 1) and at the end of intervention (day 2)
|
The Stigma of Suicide Scale (SOSS) measures public attitudes and stigma toward suicide, aiding research on societal perceptions and informing anti-stigma interventions to improve mental health outcomes.
The long form consists of 58 items and the short form consists of 16 items.
Each item consists of a one-word descriptor of a person who dies by suicide.
A person completes the scale by rating how much they agree with each item being a descriptor of someone who takes their own life.
Each item is to be rated on a 5-point Likert scale from (1) strongly disagree to (5) strongly agree.
Higher scores indicate higher levels of stigma towards people who suicide.
|
Baseline (day 1) and at the end of intervention (day 2)
|
|
Beck Hopelessness Scale (BHS)
大体时间：Baseline (day 1) and at the end of intervention (day 2)
|
The Beck Hopelessness Scale (BHS) is a 20-item, true/false self-report inventory designed to measure an individual's negative attitudes or pessimism about the future.
Lower score indicate none or minimal while higher score indicate severe.
|
Baseline (day 1) and at the end of intervention (day 2)
|
|
Patient Health Questionnaire-9 (PHQ-9)
大体时间：Baseline (day 1) and at the end of intervention (day 2)
|
The Patient Health Questionnaire-9 (PHQ-9) is a standard diagnostic tool used to screen for and measure the severity of depression.
Scores range from 0 to 27, calculated by assigning 0 to 3 points for each of the nine questions.
Scores ≤4 suggest minimal depression which may not require treatment.
Higher score suggest depression.
|
Baseline (day 1) and at the end of intervention (day 2)
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
大体时间：Baseline (day 1) and at the end of intervention (day 2)
|
The PCL-5 is a 20-item self-report questionnaire used to assess PTSD symptoms based on DSM-5 criteria.
It evaluates symptoms over the past month on a 0 to 4 scale, yielding a total severity score from 0 to 80.
A score of 31-33 or higher is generally considered the clinical cutoff.
Scores in this range suggest a provisional PTSD diagnosis.
|
Baseline (day 1) and at the end of intervention (day 2)
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Pirkis J, Rossetto A, Nicholas A, Ftanou M, Robinson J, Reavley N. Suicide Prevention Media Campaigns: A Systematic Literature Review. Health Commun. 2019 Apr;34(4):402-414. doi: 10.1080/10410236.2017.1405484. Epub 2017 Nov 30.
- Ftanou M, Cox G, Nicholas A, Spittal MJ, Machlin A, Robinson J, Pirkis J. Suicide Prevention Public Service Announcements (PSAs): Examples from Around the World. Health Commun. 2017 Apr;32(4):493-501. doi: 10.1080/10410236.2016.1140269. Epub 2016 Jun 16.
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 (估计的)
2026年6月30日
初级完成 (估计的)
2027年6月3日
研究完成 (估计的)
2027年6月3日
研究注册日期
首次提交
2026年5月30日
首先提交符合 QC 标准的
2026年5月30日
首次发布 (实际的)
2026年6月4日
研究记录更新
最后更新发布 (实际的)
2026年6月4日
上次提交的符合 QC 标准的更新
2026年5月30日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- 0000-0003-0516-0313h
- CONSCIOUS (其他标识符：Teesside University)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Data supporting this study cannot be made available due to the sensitive nature and ethical reasons on confidentiality.
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
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.