Stress Reduction: A Pilot Study With Adolescents

Not Applicable

Completed

• Conditions: Physiological Stress; Psychological Stress
• Interventions: Other: Wellness; Other: Mindfulness

• Registration Number: NCT02629016
• Lead Sponsor: Oregon Health and Science University

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-12-08
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-11
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 285

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.

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wellness	Wellness	Education and experiential exercises for general wellness including sleep hygiene, goal setting and power poses.
Mindfulness	Mindfulness	Education and experiential exercises for mindfulness including movement, thoughts and meditation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Sleep Quality	Change score from baseline (week 0) to post-intervention (week 9) on sleep	Baseline to post-intervention or waitlist sleep change score
Stress Reactivity	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
Stress reactivity	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	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)	Change score from baseline (week 0) to post-intervention (week 9) on PSS	Baseline to post-intervention or waitlist PSS change score
Five Factor Mindfulness Questionnaire (FFMQ)	Change score from baseline (week 0), post-intervention (week 9) on FFMQ	Change in FFMQ score from baseline to post-intervention or waitlist