Nocebo Education to Reduce the Potential Unintended Harms of Mental Health Awareness

Not Applicable

Completed

• Conditions: ADHD

• Registration Number: NCT06638411
• Lead Sponsor: University of Toronto

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).

Study Timeline

• Study First Submitted: 2024-10-09
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-15
• Study Start: 2024-10-16
• Primary Completion: 2024-12-08
• Study Completion: 2024-12-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-16
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-reported ADHD symptoms	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	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.

Secondary Outcome Measures

Name	Time	Method
Memory Failures	Change, 1 week	Measured by Memory Failures Scale (MFS), a self-reported scale. The scale ranges in scores from 12-60, where a higher score indicates more failures.
Depressive and Anxiety Symptoms	Change, 1 week	As measured by the Kessler General Distress Scale (K10). The scale score ranges from 10 to 50, where higher scores indicate more symptoms.

Trial Locations

Locations (1)

University of Toronto; 🇨🇦 Toronto, Ontario, Canada