Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638411
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Nocebo Education to Reduce the Potential Unintended Harms of Mental Health Awareness
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Nocebo Education to Reduce the Potential Unintended Harms of Mental Health Awareness
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
Rates of mental health problems have risen dramatically in North America and around the world The high rates of mental health problems led to more mental health awareness efforts on university campuses in the workplaces and online These efforts have greatly destigmatised mental health and increased help seeking across all ages but may also induce the nocebo effect it may create negative expectations about ones mental health status and thus paradoxically worsen the very symptoms they try to prevent Nocebo effect is well known to cause various negative outcomes in medicine such as worse medication side effects For instance when the person takes the drug she can have negative expectations about having side effects and experience them due to misinterpreting normal but ambiguous physical sensations as the relevant side effects Mental health awareness campaigns may follow the same pattern they may reframe normal difficulties that are typical of emerging adulthood as early symptoms of psychiatric disorders thus exacerbating mental health concerns Experts are now calling for more balanced approaches to mental health awareness that provide necessary information without causing unintended harms
This will be a randomized controlled trial designed to evaluate whether mental health awareness induces worsening of symptoms unintended harms and whether nocebo education can reduce or inoculate against these Participants in this study will be recruited from the University of Toronto community and complete the study in small to medium sized groups
Groups of participants will be assigned to one of the three conditions using block randomisation in a 111 ratio The three conditions will include two experimental conditions and an active control ADHD information workshop ADHD information with nocebo education workshop or a control sleep education workshop Participants will report their ADHD symptoms and rates of self-diagnosis prior to participating in the workshop immediately after self-diagnosis and at one-week follow-up both
This will be a randomized controlled trial designed to evaluate whether mental health awareness induces worsening of symptoms unintended harms and whether nocebo education can reduce or inoculate against these Participants in this study will be recruited from the University of Toronto community and complete the study in small to medium sized groups
Groups of participants will be assigned to one of the three conditions using block randomisation in a 111 ratio The three conditions will include two experimental conditions and an active control ADHD information workshop ADHD information with nocebo education workshop or a control sleep education workshop Participants will report their ADHD symptoms and rates of self-diagnosis prior to participating in the workshop immediately after self-diagnosis and at one-week follow-up both
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None