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

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Contents

clinicaltrials.gov/study/NCT06638411
Is a
‌
Clinical study
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Clinical Study attributes

NCT Number
NCT066384110
Health Conditions in Trial
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Adhd
0
Trial Recruitment Size
2400
Trial Sponsor
University of Toronto
University of Toronto
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Clinical Trial Start Date
2024
0
Primary Completion Date
2025
0
Study Completion Date
2025
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Prevention0
Intervention Type
Behavioral0
Interventional Trial Phase
Not Applicable0
Participating Facility
University of Toronto
University of Toronto
0
Official Name
Nocebo Education to Reduce the Potential Unintended Harms of Mental Health Awareness0
Last Updated
October 15, 2024
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Double0
Masked Party
Participant0
Investigator0

Other attributes

Intervention Treatment
ADHD information workshop0
ADHD information workshop with nocebo education0
Sleep workshop0
Study 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.

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