Stress Reduction: A Pilot Study With Adolescents

NCT ID: NCT02629016

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 285 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-06-30

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.

Conditions

Physiological Stress; Psychological Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Mindfulness

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

Group Type: EXPERIMENTAL

Mindfulness

Intervention Type: OTHER

Wellness

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

Group Type: ACTIVE_COMPARATOR

Wellness

Intervention Type: OTHER

Waitlist

Students receive regular health class instruction without intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness

Intervention Type: OTHER

Wellness

Intervention Type: OTHER

Eligibility Criteria

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

-

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Jeanette Johnstone

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joel Nigg, PhD

Role: PRINCIPAL_INVESTIGATOR

OHSU, Psychiatry

Other Identifiers

IRB00011301

Identifier Type: -

Identifier Source: org_study_id