Stress Reduction: A Pilot Study With Adolescents

Oregon Health and Science University285 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

285

Conditions

Physiological Stress Psychological Stress

Interventions

MindfulnessOTHER

WellnessOTHER

Eligibility

Sex: ALLMin age: 14 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: \-

Outcomes

Primary Outcomes

Depression Anxiety and Stress Scale (DASS)

Baseline to post-intervention or waitlist DASS change score

Time frame: 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

Time frame: 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

Time frame: Change score from baseline (week 0) to post-intervention (week 9) on ATQ

Secondary Outcomes

Sleep Quality

Baseline to post-intervention or waitlist sleep change score

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Change score from baseline (week 0) to post-intervention (week 9) blood pressure (BP) sys/dia measurement

Data from ClinicalTrials.gov

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