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.

Study Overview

• Status: Completed
• Conditions: Psychological Stress; Physiological Stress
• Intervention / Treatment: Other: Mindfulness; Other: Wellness

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 285
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Joel Nigg, PhD, OHSU, Psychiatry

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 8, 2015
• First Submitted That Met QC Criteria: December 9, 2015
• First Posted (Estimate): December 11, 2015

Study Record Updates

• Last Update Posted (Estimate): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: IRB00011301