NCT Number: NCT02629016
Stress Reduction: A Pilot Study With Adolescents
This study will evaluate the feasibility of providing an onsite mindfulness intervention, delivered as part of the school health curriculum, to help high school-attending adolescents cope with stress.
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Conditions
Age range
14 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
For this study, sophomores who are enrolled in health at Jesuit High School, (n = 320 students) will be invited to participate in a research study, conducted during health class, comparing mindfulness to a wellness or waitlist control. The students will be randomized by classroom, to either wellness or mindfulness or waitlist, with approximately 3-4 classes per intervention or control. Initially, six classes or sections of health will be randomized to one of the two active interventions, with the remaining classes/sections of health on the waitlist. Both of the intervention groups will meet weekly, during one of the regularly scheduled health classes, and have daily assignments. The students in the waitlisted classrooms will receive an intervention at the start of the next term. At the end of the study, students will have access to the materials from the other group, if desired.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Gender:
•Both: both female and male participants are being studied
Age for students:
•Minimum age 13 year, 0 months; •Maximum:16 years, 0 months
Age for parents:
N/A°
Inclusion criteria
Adolescents who are enrolled in health class at Jesuit High School,
- Who have access to an iPad, cell phone or computer,
- Are considered reliable and compliant with the study protocol including willing to abide by randomization process, willingness to commit to daily practice activities for the duration of the study.
- Students taking psychiatric medication including stimulants, anti-depressants or anxiolytics are eligible to participate provided they are stable on their current dose of medication, have been taking it for at least two weeks, and will remain on the same dose for the remainder of the study. Any changes in medication will be noted.
Exclusion:
- Intellectual disability, as reported by parent or teacher;
- Current manic episode
- Psychotic episode
- Untreated Post Traumatic Stress Disorder, identified through parent or student report.
Exclusion criteria
-
Treatment and study plan
Wellness
OtherPrimary outcomes
-
Depression Anxiety and Stress Scale (DASS)
Time frame: Change in DASS score from baseline (week 0) to post-intervention (week 9)
Baseline to post-intervention or waitlist DASS change score
-
Conners 3 Short Form
Time frame: Change score from baseline (week 0) to post-intervention (week 9) on Conners
Baseline to post-intervention or waitlist Conners change score
-
Automatic Thoughts Questionnaires (ATQ)
Time frame: Change score from baseline (week 0) to post-intervention (week 9) on ATQ
Baseline to post-intervention or waitlist ATQ change score
Secondary outcomes
-
Sleep Quality
Time frame: Change score from baseline (week 0) to post-intervention (week 9) on sleep
Baseline to post-intervention or waitlist sleep change score
-
Stress Reactivity
Time frame: Change score from baseline (week 0) to post-intervention (week 9) in beats per minute
Change score from baseline to post intervention or waitlist on heart rate/pulse
-
Five Factor Mindfulness Questionnaire (FFMQ)
Time frame: Change score from baseline (week 0), post-intervention (week 9) on FFMQ
Change in FFMQ score from baseline to post-intervention or waitlist
-
Stress reactivity
Time frame: Change score from baseline (week 0) to post-intervention (week 9) blood pressure (BP) sys/dia measurement
Change score from baseline to post intervention or waitlist on BP
-
Self-report stress on behavioral tasks
Time frame: Change score from baseline (week 0) to post-intervention (week 9) on self-rated stress (0-10 likert scale)
Change from baseline to post-intervention or waitlist on self-reported stress following behavioral tasks
-
Perceived Stress Scale (PSS)
Time frame: Change score from baseline (week 0) to post-intervention (week 9) on PSS
Baseline to post-intervention or waitlist PSS change score
Sponsors and collaborators
Lead sponsor
Oregon Health and Science University
Other
Registry information
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Dec 11, 2015
- Registry last updated
- Jan 25, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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