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

NCT06638411 | Completed

• 1 other identifier: 45738
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief 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. 1.Randomize the participants to one of the three workshop conditions to watch
2. 2.Report self-diagnosis score immediately after the workshop and 1 week later.
3. 3.Report symptoms 1 week later.

Conditions

ADHD

Keywords

ADHD; Nocebo Effect; Mental Health Awareness

Outcome Measures

Primary Outcomes (2)

• Self-reported ADHD symptoms

  As measured by Adult ADHD Self-Reported Symptom Scale (ASRS), a self-reported scale of ADHD symptoms with a score range of 0-72, with a higher score indicating worse symptoms.

  Change 1 week

• Self-diagnosis with ADHD

  As measured by one item with a score range from 1 to 5, with a higher score indicating stronger self-diagnosing belief.

  Change: Immediate, 1 week

Secondary Outcomes (2)

• Memory Failures

  Change, 1 week

• Depressive and Anxiety Symptoms

  Change, 1 week

Study Arms (3)

ADHD information workshop

EXPERIMENTAL

Behavioral: ADHD information workshop

ADHD information workshop with nocebo education

EXPERIMENTAL

Behavioral: ADHD information workshop with nocebo education

Sleep and dreams workshop

ACTIVE COMPARATOR

Behavioral: Sleep workshop

Interventions

ADHD information workshop BEHAVIORAL

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.

ADHD information workshop

ADHD information workshop with nocebo education BEHAVIORAL

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.

ADHD information workshop with nocebo education

Sleep workshop BEHAVIORAL

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.

Sleep and dreams workshop

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• No existing diagnosis of ADHD, or history/current diagnosis of any other neurological/psychiatric disorder.
• Score below 18 on the Adult ADHD Self-Reported Symptom (ASRS) Checklist Screener.
• No current intake of medication to treat a psychiatric disorder (e.g., antidepressants)
• Fluent in English;
• Access to a computer, tablet, or smartphone with internet capability;
• Normal or corrected-to-normal vision and hearing.

You may not qualify if:

• Diagnosis of ADHD or any other neurological/psychiatric disorder.
• Active intake of medication.

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

University of Toronto

Toronto, Ontario, M1C 1A4, Canada

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be blinded to the study hypotheses and treatment arms, and to the type of intervention they are receiving. Outcome assessors will be blinded to participants' treatment arm assignment and the type of intervention they are receiving.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: October 16, 2024
• Primary Completion: December 8, 2024
• Study Completion: December 8, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

CA (1)