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Behavioral Intervention
Mindfulness for Stress and ADHD
N/A
Recruiting
Led By Nancy L. Heath, Ph.D.
Research Sponsored by McGill University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 1, 6, 10, and 18
Awards & highlights
No Placebo-Only Group
Summary
This trial will study uni students with stress, ADHD, or NSSI to see if mindfulness instruction helps. It will compare formal & informal mindfulness & a control group.
Who is the study for?
This trial is for McGill or Concordia University students aged 18-29 who self-report stress, ADHD, or have a history of non-suicidal self-injury (NSSI) on at least five different days in the past year. It's not open to those whose NSSI doesn't meet specific recent and frequent criteria.
What is being tested?
The study compares two types of mindfulness programs: formal and informal instruction, over four weeks. Participants will be randomly assigned to one of these programs or a control group without any intervention to see which is more acceptable and effective.
What are the potential side effects?
Mindfulness practices are generally considered safe but may sometimes lead to increased anxiety, emotional discomfort, or distraction during initial practice as individuals become more aware of their thoughts and feelings.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 1, 6, 10, and 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 1, 6, 10, and 18
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dispositional mindfulness
Secondary study objectives
Academic engagement
Acceptability (as measured by the IMI)
Acceptability (as measured by the TFA questionnaire)
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Informal mindfulness instructionExperimental Treatment1 Intervention
Group II: Formal mindfulness instructionExperimental Treatment1 Intervention
Group III: Inactive controlActive Control1 Intervention
An equal number of university students from all groups will participate in this arm (i.e., those with ADHD, those with a history of nonsuicidal self-injury, and those with self-reported stress). Participants assigned to the inactive control condition will not complete any tasks during the four-week intervention period.
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Who is running the clinical trial?
McGill UniversityLead Sponsor
412 Previous Clinical Trials
1,018,176 Total Patients Enrolled
2 Trials studying Mindfulness
528 Patients Enrolled for Mindfulness
Concordia University, MontrealOTHER
28 Previous Clinical Trials
4,861 Total Patients Enrolled
University of OttawaOTHER
221 Previous Clinical Trials
269,289 Total Patients Enrolled
University of TorontoOTHER
721 Previous Clinical Trials
1,114,899 Total Patients Enrolled
Nancy L. Heath, Ph.D.Principal InvestigatorMcGill University
1 Previous Clinical Trials
254 Total Patients Enrolled
1 Trials studying Mindfulness
254 Patients Enrolled for Mindfulness