Stress Reduction: A Pilot Study With Adolescents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 285
- Primary Endpoint
- Depression Anxiety and Stress Scale (DASS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •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
- Not provided
Outcomes
Primary Outcomes
Depression Anxiety and Stress Scale (DASS)
Time Frame: 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)
Time Frame: 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
Time Frame: Change score from baseline (week 0) to post-intervention (week 9) on Conners
Baseline to post-intervention or waitlist Conners change score
Secondary Outcomes
- Sleep Quality(Change score from baseline (week 0) to post-intervention (week 9) on sleep)
- Stress Reactivity(Change score from baseline (week 0) to post-intervention (week 9) in beats per minute)
- Stress reactivity(Change score from baseline (week 0) to post-intervention (week 9) blood pressure (BP) sys/dia measurement)
- 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))
- Perceived Stress Scale (PSS)(Change score from baseline (week 0) to post-intervention (week 9) on PSS)
- Five Factor Mindfulness Questionnaire (FFMQ)(Change score from baseline (week 0), post-intervention (week 9) on FFMQ)
Investigators
Jeanette Johnstone
Principal Investigator
Oregon Health and Science University