Nocebo Education for ADHD Awareness

Overseen By Dean Sharpe

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Must not be taking: Psychiatric medications

Disqualifiers: ADHD, Neurological disorders, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

215 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{11 12 13 14 15}

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

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

Group I: ADHD information workshop with nocebo education Experimental Treatment 1 Intervention

Group II: ADHD information workshop Experimental Treatment 1 Intervention

Group III: Sleep and dreams workshop Active Control 1 Intervention

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimizing Drug Adverse Events by Informing About the Nocebo Effect-An Experimental Study. Pan, Y., Kinitz, T., Stapic, M., et al.[2020]

A meta-analysis of 128 randomized controlled trials involving over 19,000 participants revealed significant placebo effects on the efficacy of ADHD medications, indicating that non-specific factors can influence treatment outcomes.

While ADHD medications are more effective than placebo, the study highlights the importance of understanding and potentially incorporating placebo-related factors into clinical practice to enhance treatment responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo and nocebo responses in randomised, controlled trials of medications for ADHD: a systematic review and meta-analysis. Faraone, SV., Newcorn, JH., Cipriani, A., et al.[2022]

Nocebo effects, which can cause side effects from treatments due to negative expectations or previous experiences, are significant and can be triggered by how risk information is communicated to patients, as shown in various studies including those in neurology and psychiatry.

Effective communication about risks, including balancing it with positive treatment aspects and fostering a trusting doctor-patient relationship, can help mitigate nocebo effects and improve patient outcomes, highlighting the importance of informed consent in medical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nocebo, informed consent and doctor-patient communication]. Hansen, E., Zech, N., Benson, S.[2020]

A study analyzing adverse events from nonstimulant ADHD medications (atomoxetine, clonidine, and guanfacine) found that common side effects include ineffectiveness (up to 14.15%), fatigue (8.93%), and somnolence (up to 10.16%).

Suicidal ideation was reported among users of all three medications, highlighting the importance of monitoring and educating patients about potential serious side effects, even though they occur less frequently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective analysis of adverse events associated with non-stimulant ADHD medications reported to the united states food and drug administration. Pang, L., Sareen, R.[2021]

This study evaluated the effectiveness and safety of acupuncture for treating ADHD in children, involving 80 participants divided into two groups: one receiving acupuncture and the other on a waitlist for treatment.

The acupuncture group underwent 12 sessions over 6 weeks, with outcomes measured using the Korean ADHD-Rating Scale, aiming to provide evidence for acupuncture as a viable treatment option for ADHD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture for attention deficit hyperactivity disorder (ADHD): study protocol for a randomised controlled trial. Hong, SS., Cho, SH.[2021]

A review of adverse event reports (AERs) found that interactions between herbal remedies and ADHD medications, particularly involving St. John's wort and methylphenidate, could lead to potential adverse effects in pediatric patients.

Out of 23 AERs identified, only five were detailed enough to assess causality, with one interaction deemed probable and another possible, highlighting the need for better reporting quality and further research on these interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Natural Health Product-Drug Interaction Causality Assessment in Pediatric Adverse Event Reports Associated with Attention-Deficit/Hyperactivity Disorder Medication. Mazhar, H., Foster, BC., Necyk, C., et al.[2021]

The safety profile of ADHD medications is not fully understood, with concerns about both older and newer medications potentially causing serious adverse effects, including sudden cardiac death and suicidality.

A review by the European Network for Hyperkinetic Disorders highlighted that while some adverse effects may be minimal or similar to risks in untreated individuals, further research is needed to clarify the safety risks associated with ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European guidelines on managing adverse effects of medication for ADHD. Graham, J., Banaschewski, T., Buitelaar, J., et al.[2022]

This study aims to systematically evaluate the efficacy and safety of acupuncture for treating Attention Deficit Hyperactivity Disorder (ADHD) by analyzing various databases for relevant literature up to September 2019.

The research will assess high-quality evidence regarding acupuncture's effectiveness through multiple measures, including the Conners Child Hyperactivity Diagnosis Rating Scale, which will help determine if acupuncture is a viable treatment option for ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture treatment on attention deficit hyperactivity disorder: A protocol for systematic review and meta-analysis. Xing, L., Ren, Z., Yue, X., et al.[2023]

Multivitamin/mineral supplements and essential fatty acids (like eicosapentaenoic acid and docosahexaenoic acid) are recommended as potential dietary interventions for ADHD, with some controlled studies supporting their use.

Eliminating artificial food dyes may help reduce ADHD symptoms, but this approach is more relevant for the general pediatric population rather than specifically for diagnosed ADHD children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary and nutritional treatments for attention-deficit/hyperactivity disorder: current research support and recommendations for practitioners. Hurt, EA., Arnold, LE., Lofthouse, N.[2021]

Many complementary and alternative treatments for attention-deficit/hyperactivity disorder (ADHD) lack conclusive evidence for their effectiveness and safety, but some are safe and reasonable enough to warrant individual patient trials.

There is a significant need to strengthen the evidence base for these treatments, particularly for supplements or off-label medications that can be tested against placebos in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention-deficit/hyperactivity disorder: dietary and nutritional treatments. Arnold, LE., Hurt, E., Lofthouse, N.[2013]

Over half (54%) of parents surveyed reported using complementary and alternative medicine (CAM) therapies, such as expressive therapies and nutritional supplements, for their children's attention problems related to ADHD.

Parents who opted for CAM emphasized the importance of 'natural therapy' and 'having more control over treatments,' yet only 11% discussed these therapies with their child's physician, highlighting a need for pediatricians to engage in conversations about CAM use with families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary and alternative therapies in childhood attention and hyperactivity problems. Chan, E., Rappaport, LA., Kemper, KJ.[2019]

The study involved 41 children with ADHD who participated in either neurofeedback or standard computer-based attention training, showing significant improvements in attention-related behaviors as reported by parents and teachers.

Both training methods were effective, with neurofeedback leading to notable changes in various behavioral assessments, while the standard computer format also showed significant improvements in attention problems, indicating that computer-based interventions can be beneficial for children with ADHD in school settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based attention training in the schools for children with attention deficit/hyperactivity disorder: a preliminary trial. Steiner, NJ., Sheldrick, RC., Gotthelf, D., et al.[2022]

In a study of 104 children aged 7 to 11 with ADHD, those who received neurofeedback showed sustained improvements in attention and executive functioning six months after a 40-session intervention, with effect sizes indicating significant benefits over cognitive training and control groups.

Neurofeedback participants maintained their stimulant medication dosage, while those in cognitive training and control groups required significant increases in medication, suggesting that neurofeedback may be a more effective treatment option for managing ADHD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-school neurofeedback training for ADHD: sustained improvements from a randomized control trial. Steiner, NJ., Frenette, EC., Rene, KM., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patient Education in Psychopharmacology and the Risk of Nocebo-Related Treatment Inefficacy and Harm. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The Nocebo Effect and Pediatric Concussion. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Minimizing Drug Adverse Events by Informing About the Nocebo Effect-An Experimental Study. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Placebo and nocebo responses in randomised, controlled trials of medications for ADHD: a systematic review and meta-analysis. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[Nocebo, informed consent and doctor-patient communication]. [2020]

6. Ireland pubmed.ncbi.nlm.nih.gov

Retrospective analysis of adverse events associated with non-stimulant ADHD medications reported to the united states food and drug administration. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Acupuncture for attention deficit hyperactivity disorder (ADHD): study protocol for a randomised controlled trial. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Natural Health Product-Drug Interaction Causality Assessment in Pediatric Adverse Event Reports Associated with Attention-Deficit/Hyperactivity Disorder Medication. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

European guidelines on managing adverse effects of medication for ADHD. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Acupuncture treatment on attention deficit hyperactivity disorder: A protocol for systematic review and meta-analysis. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Dietary and nutritional treatments for attention-deficit/hyperactivity disorder: current research support and recommendations for practitioners. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Attention-deficit/hyperactivity disorder: dietary and nutritional treatments. [2013]

13. United States pubmed.ncbi.nlm.nih.gov

Complementary and alternative therapies in childhood attention and hyperactivity problems. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Computer-based attention training in the schools for children with attention deficit/hyperactivity disorder: a preliminary trial. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

In-school neurofeedback training for ADHD: sustained improvements from a randomized control trial. [2022]