Nocebo Education to Reduce the Potential Unintended Harms of Mental Health Awareness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 2
- 主要终点
- Self-reported ADHD symptoms
研究概览
简要总结
This project has two aims. First, the research team will confirm whether providing a mental health awareness workshop poses unintended harms by raising the rate of self-diagnosis (as opposed to a neutral workshop) and causing worsening symptoms in previously healthy young adults over a period of one week. The study will focus on determining this in the context of ADHD, as it includes broad symptoms that overlap with normal experience, is commonly overdiagnosed, and is included in many awareness campaigns for neurodiversity and mental health.
Second, the study will test whether nocebo effect education, or in other words, learning about the nocebo effects, during mental health awareness sessions "inoculates" against them. Simply learning about the role negative expectations play in creating side effects has been shown to reduce nocebo side effects of medications; perhaps, the same applies to mental health.
Researchers will compare the outcome of the ADHD workshop with that of the same workshop but with nocebo information included; both experimental conditions will also be compared to an active control condition. Participants are hypothesised to report the following pattern of symptoms:
ADHD information > ADHD + nocebo education > Control
During the study participants will:
- Randomize the participants to one of the three workshop conditions to watch
- Report self-diagnosis score immediately after the workshop and 1 week later.
- Report symptoms 1 week later.
详细描述
Rates of mental health problems have risen dramatically in North America and around the world. The high rates of mental health problems led to more mental health awareness efforts on university campuses, in the workplaces, and online. These efforts have greatly destigmatised mental health and increased help seeking across all ages, but may also induce the nocebo effect: it may create negative expectations about one's mental health status and thus paradoxically worsen the very symptoms they try to prevent. Nocebo effect is well known to cause various negative outcomes in medicine, such as worse medication side effects. For instance, when the person takes the drug, she can have negative expectations about having side effects and experience them due to misinterpreting normal but ambiguous physical sensations as the relevant side effects. Mental health awareness campaigns may follow the same pattern: they may reframe normal difficulties that are typical of emerging adulthood as early symptoms of psychiatric disorders, thus exacerbating mental health concerns. Experts are now calling for more balanced approaches to mental health awareness that provide necessary information without causing unintended harms.
This will be a randomized controlled trial designed to evaluate whether mental health awareness induces worsening of symptoms (unintended harms) and whether nocebo education can reduce or inoculate against these. Participants in this study will be recruited from the University of Toronto community and complete the study in small to medium sized groups.
Groups of participants will be assigned to one of the three conditions using block randomisation (in a 1:1:1 ratio). The three conditions will include two experimental conditions and an active control: ADHD information workshop, ADHD information with nocebo education workshop, or a control sleep education workshop. Participants will report their ADHD symptoms and rates of self-diagnosis prior to participating in the workshop, immediately after (self-diagnosis), and at one-week follow-up (both).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants will be blinded to the study hypotheses and treatment arms, and to the type of intervention they are receiving. Outcome assessors will be blinded to participants' treatment arm assignment and the type of intervention they are receiving.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No existing diagnosis of ADHD, or history/current diagnosis of any other neurological/psychiatric disorder.
- •Score below 18 on the Adult ADHD Self-Reported Symptom (ASRS) Checklist Screener.
- •No current intake of medication to treat a psychiatric disorder (e.g., antidepressants)
- •Fluent in English;
- •Access to a computer, tablet, or smartphone with internet capability;
- •Normal or corrected-to-normal vision and hearing.
排除标准
- •Diagnosis of ADHD or any other neurological/psychiatric disorder.
- •Active intake of medication.
结局指标
主要结局
Self-reported ADHD symptoms
时间窗: Change 1 week
As measured by Adult ADHD Self-Reported Symptom Scale (ASRS), a self-reported scale of ADHD symptoms with a score range of 0-72, with a higher score indicating worse symptoms.
Self-diagnosis with ADHD
时间窗: Change: Immediate, 1 week
As measured by one item with a score range from 1 to 5, with a higher score indicating stronger self-diagnosing belief.
次要结局
- Memory Failures(Change, 1 week)
- Depressive and Anxiety Symptoms(Change, 1 week)
研究者
Daria Sandra
Principal Investigator
University of Toronto