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Stress Reduction: A Pilot Study With Adolescents

Stress Reduction: A Pilot Study With Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02629016
Enrollment
285
Registered
2015-12-11
Start date
2015-09-30
Completion date
2016-06-30
Last updated
2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physiological Stress, Psychological Stress

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.

Interventions

OTHERMindfulness
OTHERWellness

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
Yes

Inclusion 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

\-

Design outcomes

Primary

MeasureTime frameDescription
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
Conners 3 Short FormChange score from baseline (week 0) to post-intervention (week 9) on ConnersBaseline to post-intervention or waitlist Conners change score
Automatic Thoughts Questionnaires (ATQ)Change score from baseline (week 0) to post-intervention (week 9) on ATQBaseline to post-intervention or waitlist ATQ change score

Secondary

MeasureTime frameDescription
Stress reactivityChange score from baseline (week 0) to post-intervention (week 9) blood pressure (BP) sys/dia measurementChange score from baseline to post intervention or waitlist on BP
Sleep QualityChange score from baseline (week 0) to post-intervention (week 9) on sleepBaseline to post-intervention or waitlist sleep change score
Perceived Stress Scale (PSS)Change score from baseline (week 0) to post-intervention (week 9) on PSSBaseline to post-intervention or waitlist PSS change score
Self-report stress on behavioral tasksChange 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
Stress ReactivityChange score from baseline (week 0) to post-intervention (week 9) in beats per minuteChange score from baseline to post intervention or waitlist on heart rate/pulse
Five Factor Mindfulness Questionnaire (FFMQ)Change score from baseline (week 0), post-intervention (week 9) on FFMQChange in FFMQ score from baseline to post-intervention or waitlist

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026