Overview

This trial is active, not recruiting.

Conditions physiological stress, psychological stress
Treatments mindfulness, wellness
Sponsor Oregon Health and Science University
Start date September 2015
End date May 2016
Trial size 320 participants
Trial identifier NCT02629016, IRB00011301

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
Education and experiential exercises for mindfulness including movement, thoughts and meditation
mindfulness
(Active Comparator)
Education and experiential exercises for general wellness including sleep hygiene, goal setting and power poses.
wellness
(No Intervention)
Students receive regular health class instruction without intervention.

Primary Outcomes

Measure
Depression Anxiety and Stress Scale (DASS)
time frame: Change in DASS score from baseline (week 0) to post-intervention (week 9)
Conners 3 Short Form
time frame: Change score from baseline (week 0) to post-intervention (week 9) on Conners
Automatic Thoughts Questionnaires (ATQ)
time frame: Change score from baseline (week 0) to post-intervention (week 9) on ATQ

Secondary Outcomes

Measure
Sleep Quality
time frame: Change score from baseline (week 0) to post-intervention (week 9) on sleep
Stress Reactivity
time frame: Change score from baseline (week 0) to post-intervention (week 9) in beats per minute
Five Factor Mindfulness Questionnaire (FFMQ)
time frame: Change score from baseline (week 0), post-intervention (week 9) on FFMQ
Stress reactivity
time frame: Change score from baseline (week 0) to post-intervention (week 9) blood pressure (BP) sys/dia measurement
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)
Perceived Stress Scale (PSS)
time frame: Change score from baseline (week 0) to post-intervention (week 9) on PSS

Eligibility Criteria

Male or female participants from 14 years up to 70 years old.

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:

Additional Information

Official title Stress Reduction: A Pilot Study With Adolescents
Principal investigator Joel Nigg, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.