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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how mental health workshops about ADHD (Attention Deficit Hyperactivity Disorder) affect young adults. It examines whether these workshops might unintentionally increase self-diagnosis or worsen symptoms in individuals without ADHD. The trial also investigates whether teaching about the nocebo effect (where negative expectations can cause symptoms) during these workshops, known as Nocebo Education, can help reduce such effects. Participants will attend one of three different workshops and report their symptoms and self-diagnosis immediately after and one week later. Ideal participants are young adults with no history of neurological or psychiatric disorders who have internet access to attend the sessions. As an unphased trial, this study offers a unique opportunity to contribute to understanding the broader impacts of mental health education.

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 prior data suggests that these workshops are safe?

Research has shown that the nocebo effect, where negative expectations cause side effects, is common in ADHD studies. People might report side effects even without receiving actual treatment. Although specific safety data on teaching about the nocebo effect is lacking, learning about it generally reduces these negative side effects. Understanding how expectations affect symptoms might help some people feel better.

In this study, participants attend a workshop to learn about the nocebo effect, providing a safe and simple educational method. As a "Not Applicable" phase trial, it focuses on understanding the impact of education rather than testing a new drug. Therefore, there are no major safety concerns related to the treatment itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nocebo Education for ADHD because it explores how understanding the nocebo effect might improve ADHD management. Unlike the standard medications like stimulants and non-stimulants that directly target brain chemistry, this approach focuses on educating patients about the psychological impacts of negative expectations. By increasing awareness of the nocebo effect, the treatment aims to empower patients and potentially enhance the effectiveness of existing therapies. This innovative educational method could lead to more informed patients and possibly reduce reliance on medication alone.

What evidence suggests that this trial's workshops could be effective for ADHD awareness?

Research shows that learning about the nocebo effect can reduce negative symptoms stemming from expecting bad outcomes. Studies on ADHD have demonstrated that nocebo responses often influence medication reactions, affecting both efficacy and safety. This trial includes an "ADHD information workshop with nocebo education" arm, where participants will learn about the nocebo effect. Understanding the role of expectations may lead to fewer side effects. For ADHD, educating individuals about the nocebo effect aims to reveal how thoughts might exacerbate symptoms. This approach could also reduce the likelihood of self-diagnosis and symptom worsening in mental health awareness settings. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

Citations

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Nocebo Effect on Pain Perception and Attention with ... When comparing groups, the nocebo effect on pain perception was similar for children with and without ADHD. Inattention, learning problems, ...

2. withpower.com withpower.com/trial/phase-attention-deficit-hyperactivity-disorder-adhd-9-2024-29110

Nocebo Education for ADHD Awareness · Info for Participants Nocebo effects, which are negative outcomes caused by patients' negative expectations, can significantly impact recovery from pediatric concussions, potentially ...

3. jpbs.hapres.com jpbs.hapres.com/htmls/JPBS_1788_Detail.html

A Secondary Meta-Regression Analysis of the Relationship ... Nocebo responses were positively associated with treatment naivety, treatment duration, proactive adverse event collection, and high risk of bias. The ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/11/NCT06638411/Prot_SAP_000.pdf

Nocebo Education to Reduce the Potential Unintended ... Does learning about the role expectations play on one's mental health at the same time as getting the ADHD information reduce this effect?

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/10870547221075845

Nocebo Response in Attention Deficit Hyperactivity Disorder Nocebo response in ADHD RCTs is remarkable, showing a positive relationship with drug response, and a negative relationship with drug safety.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35102771/

Nocebo Response in Attention Deficit Hyperactivity Disorder Nocebo response in ADHD RCTs is remarkable, showing a positive relationship with drug response, and a negative relationship with drug safety.

7. researchgate.net researchgate.net/publication/358288368_Nocebo_Response_in_Attention_Deficit_Hyperactivity_Disorder_Meta-Analysis_and_Meta-Regression_of_105_Randomized_Clinical_Trials

Nocebo Response in Attention Deficit Hyperactivity Disorder Conclusion Nocebo response in ADHD RCTs is remarkable, showing a positive relationship with drug response, and a negative relationship with drug safety.