215 Participants Needed

Nocebo Education for ADHD Awareness

DS
DS
Overseen ByDean Sharpe
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop taking my current medications to join the trial?

Yes, you must not be taking any medications to join this trial.

What data supports the idea that Nocebo Education for ADHD Awareness is an effective treatment?

The available research shows that Nocebo Education can help reduce negative side effects by informing patients about the nocebo effect, which is when negative expectations lead to experiencing side effects. For example, in a study with participants experiencing headaches, those who received nocebo information reported fewer side effects compared to those who did not. This suggests that Nocebo Education can be effective in managing expectations and reducing unnecessary side effects, making it a useful approach in treatment.12345

What safety data exists for Nocebo Education for ADHD?

The provided research does not contain specific safety data for Nocebo Education, Nocebo Awareness, or Nocebo Information as treatments for ADHD. The studies focus on non-stimulant ADHD medications, acupuncture, and natural health product interactions, but do not mention Nocebo-related treatments. Therefore, no direct safety data for Nocebo Education for ADHD is available in the provided research.678910

Is Nocebo Education for ADHD Awareness a promising treatment?

The information provided does not mention Nocebo Education as a treatment for ADHD, so we cannot determine if it is promising based on the given research articles.1112131415

Eligibility Criteria

This trial is for healthy young adults interested in mental health. It's designed to see if learning about ADHD can unintentionally make people think they have it or worsen symptoms, and if teaching about nocebo effects (harm from negative expectations) might prevent this.

Inclusion Criteria

Fluent in English
Score below 18 on the Adult ADHD Self-Reported Symptom (ASRS) Checklist Screener
Access to a computer, tablet, or smartphone with internet capability
See 3 more

Exclusion Criteria

I am currently taking medication.
I have been diagnosed with ADHD or another neurological/psychiatric condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Workshop

Participants attend one of three workshops: ADHD information, ADHD information with nocebo education, or a control sleep education workshop

1 day
1 visit (in-person)

Immediate Post-Workshop Assessment

Participants report self-diagnosis score immediately after the workshop

Immediate

Follow-up

Participants report symptoms and self-diagnosis score 1 week after the workshop

1 week

Treatment Details

Interventions

  • Nocebo Education
Trial Overview The study compares three groups: one attends a sleep workshop, another an ADHD info workshop, and the third an ADHD workshop that includes education on nocebo effects. Participants will report self-diagnosed ADHD immediately after and one week post-workshop, plus any symptoms after a week.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: ADHD information workshop with nocebo educationExperimental Treatment1 Intervention
Group II: ADHD information workshopExperimental Treatment1 Intervention
Group III: Sleep and dreams workshopActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials
739
Recruited
1,125,000+

Findings from Research

Educating patients about potential adverse effects of medications can inadvertently increase the likelihood of experiencing those effects, a phenomenon known as the nocebo effect.
The way information is communicated to patients can influence both the effectiveness of treatment (placebo response) and the risk of adverse effects, highlighting the need for optimized patient education strategies in clinical practice.
Patient Education in Psychopharmacology and the Risk of Nocebo-Related Treatment Inefficacy and Harm.Andrade, C.[2019]
Nocebo effects, which are negative outcomes caused by patients' negative expectations, can significantly impact recovery from pediatric concussions, potentially worsening symptoms and prolonging recovery time.
The review provides practical recommendations for clinicians, including careful choice of terminology and messaging, to help mitigate nocebo effects and improve patient outcomes in pediatric concussion care.
The Nocebo Effect and Pediatric Concussion.Kirkwood, MW., Howell, DR., Brooks, BL., et al.[2022]
Informing participants about the nocebo effect through a short information sheet significantly reduced the reporting of nocebo side effects among those who received the information compared to a control group, with a notable effect size (Cohen's d = 0.59).
Despite the initial reduction in nocebo symptoms, there were no significant differences in reported side effects at a 4-day follow-up, suggesting that the immediate impact of nocebo information may not have lasting effects.
Minimizing Drug Adverse Events by Informing About the Nocebo Effect-An Experimental Study.Pan, Y., Kinitz, T., Stapic, M., et al.[2020]

References

Patient Education in Psychopharmacology and the Risk of Nocebo-Related Treatment Inefficacy and Harm. [2019]
The Nocebo Effect and Pediatric Concussion. [2022]
Minimizing Drug Adverse Events by Informing About the Nocebo Effect-An Experimental Study. [2020]
Placebo and nocebo responses in randomised, controlled trials of medications for ADHD: a systematic review and meta-analysis. [2022]
[Nocebo, informed consent and doctor-patient communication]. [2020]
Retrospective analysis of adverse events associated with non-stimulant ADHD medications reported to the united states food and drug administration. [2021]
Acupuncture for attention deficit hyperactivity disorder (ADHD): study protocol for a randomised controlled trial. [2021]
Natural Health Product-Drug Interaction Causality Assessment in Pediatric Adverse Event Reports Associated with Attention-Deficit/Hyperactivity Disorder Medication. [2021]
European guidelines on managing adverse effects of medication for ADHD. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Acupuncture treatment on attention deficit hyperactivity disorder: A protocol for systematic review and meta-analysis. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Dietary and nutritional treatments for attention-deficit/hyperactivity disorder: current research support and recommendations for practitioners. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Attention-deficit/hyperactivity disorder: dietary and nutritional treatments. [2013]
13.United Statespubmed.ncbi.nlm.nih.gov
Complementary and alternative therapies in childhood attention and hyperactivity problems. [2019]
14.United Statespubmed.ncbi.nlm.nih.gov
Computer-based attention training in the schools for children with attention deficit/hyperactivity disorder: a preliminary trial. [2022]
15.United Statespubmed.ncbi.nlm.nih.gov
In-school neurofeedback training for ADHD: sustained improvements from a randomized control trial. [2022]
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