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

NCT06638411 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2025-02-19

No results posted yet for this 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.

Conditions

  • ADHD

Interventions

BEHAVIORAL

ADHD information workshop

ADHD information workshop that will be delivered by a clinical psychology student in one 30-minute session to a group of participants. The workshop will present information about lesser-known or commonly misdiagnosed ADHD symptoms. To control for the duration of the nocebo module (see the condition below), participants will also learn about sleep and its relevance for maintenance of good cognitive health. At the end, the workshop will involve a writing reflection activity about personal experiences with ADHD symptoms.

BEHAVIORAL

ADHD information workshop with nocebo education

ADHD information workshop that will be delivered by a clinical psychology student in one 30-minute session to a group of participants. The workshop will present information about lesser-known or commonly misdiagnosed ADHD symptoms, together with a module on nocebo effects and their potential role in worsening symptoms. The nocebo module will describe the current understanding of the role of expectations in creating side effects and elaborate on how this applies to the field of mental health through a series of examples. It will also involve a writing reflection activity about personal experiences with ADHD symptoms, potential for nocebo effect when talking about ADHD symptoms, and ability to apply this information to personal experiences.

BEHAVIORAL

Sleep workshop

An information workshop about sleep and dream experiences that will be delivered by a clinical psychologist in one 30-minute session to a group of participants. It will be matched on duration, type of content, and engagingness with the experimental sessions.

Sponsors & Collaborators

  • University of Toronto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-16
Primary Completion
2024-12-08
Completion
2024-12-08

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06638411 on ClinicalTrials.gov