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OpenTrials
Completed

NCT Number: NCT02629016

Stress Reduction: A Pilot Study With Adolescents

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.

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Key information

Age range

14 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Mindfulness

Other

Wellness

Other

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Sleep Quality

    Time frame: Change score from baseline (week 0) to post-intervention (week 9) on sleep

    Baseline to post-intervention or waitlist sleep change score

  2. Stress Reactivity

    Time frame: 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

  3. Five Factor Mindfulness Questionnaire (FFMQ)

    Time frame: Change score from baseline (week 0), post-intervention (week 9) on FFMQ

    Change in FFMQ score from baseline to post-intervention or waitlist

  4. Stress reactivity

    Time frame: 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

  5. Self-report stress on behavioral tasks

    Time frame: 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

  6. Perceived Stress Scale (PSS)

    Time frame: Change score from baseline (week 0) to post-intervention (week 9) on PSS

    Baseline to post-intervention or waitlist PSS change score

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 11, 2015
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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