Stress Reduction: A Pilot Study With Adolescents

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Stress Reduction: A Pilot Study With Adolescents

Conditions
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Physiological Stress, Psychological Stress

Intervention / Treatment
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* Other: Mindfulness
* Other: Wellness


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness<br>Education and experiential exercises for mindfulness including movement, thoughts and meditation | Other: Mindfulness<br> <br> |
| Active Comparator: Wellness<br>Education and experiential exercises for general wellness including sleep hygiene, goal setting and power poses. | Other: Wellness<br> <br> |
| No Intervention: Waitlist<br>Students receive regular health class instruction without intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Anxiety and Stress Scale (DASS) | Baseline to post-intervention or waitlist DASS change score | Change in DASS score from baseline (week 0) to post-intervention (week 9) | 
| Conners 3 Short Form | Baseline to post-intervention or waitlist Conners change score | Change score from baseline (week 0) to post-intervention (week 9) on Conners | 
| Automatic Thoughts Questionnaires (ATQ) | Baseline to post-intervention or waitlist ATQ change score | Change score from baseline (week 0) to post-intervention (week 9) on ATQ | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality | Baseline to post-intervention or waitlist sleep change score | Change score from baseline (week 0) to post-intervention (week 9) on sleep | 
| Stress Reactivity | Change score from baseline to post intervention or waitlist on heart rate/pulse | Change score from baseline (week 0) to post-intervention (week 9) in beats per minute | 
| Five Factor Mindfulness Questionnaire (FFMQ) | Change in FFMQ score from baseline to post-intervention or waitlist | Change score from baseline (week 0), post-intervention (week 9) on FFMQ | 
| Stress reactivity | Change score from baseline to post intervention or waitlist on BP | Change score from baseline (week 0) to post-intervention (week 9) blood pressure (BP) sys/dia measurement | 
| Self-report stress on behavioral tasks | Change from baseline to post-intervention or waitlist on self-reported stress following behavioral tasks | Change score from baseline (week 0) to post-intervention (week 9) on self-rated stress (0-10 likert scale) | 
| Perceived Stress Scale (PSS) | Baseline to post-intervention or waitlist PSS change score | Change score from baseline (week 0) to post-intervention (week 9) on PSS |