Clinical trial NCT06638411: Nocebo Education to Reduce the Potential Unintended Harms of Mental Health Awareness
Official title: Nocebo Education to Reduce the Potential Unintended Harms of Mental Health Awareness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: ADHD
Nocebo Effect
Mental Health Awareness
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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:

1. Randomize the participants to one of the three workshop conditions to watch
2. Report self-diagnosis score immediately after the workshop and 1 week later.
3. Report symptoms 1 week later.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. No existing diagnosis of ADHD, or history/current diagnosis of any other neurological/psychiatric disorder.
2. Score below 18 on the Adult ADHD Self-Reported Symptom (ASRS) Checklist Screener.
3. No current intake of medication to treat a psychiatric disorder (e.g., antidepressants)
4. Fluent in English;
5. Access to a computer, tablet, or smartphone with internet capability;
6. Normal or corrected-to-normal vision and hearing.

Exclusion Criteria:

1. Diagnosis of ADHD or any other neurological/psychiatric disorder.
2. Active intake of medication.

Primary outcomes:
measure: Self-reported ADHD symptoms
timeFrame: Change 1 week
measure: Self-diagnosis with ADHD
timeFrame: Change: Immediate, 1 week
Secondary outcomes:
measure: Memory Failures
timeFrame: Change, 1 week
measure: Depressive and Anxiety Symptoms
timeFrame: Change, 1 week
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
References: