Stress Reduction: A Pilot Study With Adolescents

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Psychological Stress; Physiological Stress

Treatments: Other: Mindfulness; Other: Wellness

Study type: Interventional

Funder types: Other

Identifiers

NCT02629016

IRB00011301

Details and patient eligibility

About

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.

Full 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.

Enrollment: 285 patients

Sex: All

Ages: 14 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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:

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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285 participants in 3 patient groups

Mindfulness

Experimental group

Description:

Education and experiential exercises for mindfulness including movement, thoughts and meditation

Treatment:

Other: Mindfulness

Wellness

Active Comparator group

Description:

Education and experiential exercises for general wellness including sleep hygiene, goal setting and power poses.

Treatment:

Other: Wellness

Waitlist

No Intervention group

Description:

Students receive regular health class instruction without intervention.