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Stress Reduction: A Pilot Study With Adolescents

Primary Purpose

Physiological Stress, Psychological Stress

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness
Wellness
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Physiological Stress

Eligibility Criteria

14 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    Mindfulness

    Wellness

    Waitlist

    Arm Description

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

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

    Students receive regular health class instruction without intervention.

    Outcomes

    Primary Outcome Measures

    Depression Anxiety and Stress Scale (DASS)
    Baseline to post-intervention or waitlist DASS change score
    Conners 3 Short Form
    Baseline to post-intervention or waitlist Conners change score
    Automatic Thoughts Questionnaires (ATQ)
    Baseline to post-intervention or waitlist ATQ change score

    Secondary Outcome Measures

    Sleep Quality
    Baseline to post-intervention or waitlist sleep change score
    Stress Reactivity
    Change score from baseline to post intervention or waitlist on heart rate/pulse
    Five Factor Mindfulness Questionnaire (FFMQ)
    Change in FFMQ score from baseline to post-intervention or waitlist
    Stress reactivity
    Change score from baseline to post intervention or waitlist on BP
    Self-report stress on behavioral tasks
    Change from baseline to post-intervention or waitlist on self-reported stress following behavioral tasks
    Perceived Stress Scale (PSS)
    Baseline to post-intervention or waitlist PSS change score

    Full Information

    First Posted
    December 8, 2015
    Last Updated
    January 23, 2023
    Sponsor
    Oregon Health and Science University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02629016
    Brief Title
    Stress Reduction: A Pilot Study With Adolescents
    Official Title
    Stress Reduction: A Pilot Study With Adolescents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Oregon Health and Science University

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Physiological Stress, Psychological Stress

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    285 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mindfulness
    Arm Type
    Experimental
    Arm Description
    Education and experiential exercises for mindfulness including movement, thoughts and meditation
    Arm Title
    Wellness
    Arm Type
    Active Comparator
    Arm Description
    Education and experiential exercises for general wellness including sleep hygiene, goal setting and power poses.
    Arm Title
    Waitlist
    Arm Type
    No Intervention
    Arm Description
    Students receive regular health class instruction without intervention.
    Intervention Type
    Other
    Intervention Name(s)
    Mindfulness
    Intervention Type
    Other
    Intervention Name(s)
    Wellness
    Primary Outcome Measure Information:
    Title
    Depression Anxiety and Stress Scale (DASS)
    Description
    Baseline to post-intervention or waitlist DASS change score
    Time Frame
    Change in DASS score from baseline (week 0) to post-intervention (week 9)
    Title
    Conners 3 Short Form
    Description
    Baseline to post-intervention or waitlist Conners change score
    Time Frame
    Change score from baseline (week 0) to post-intervention (week 9) on Conners
    Title
    Automatic Thoughts Questionnaires (ATQ)
    Description
    Baseline to post-intervention or waitlist ATQ change score
    Time Frame
    Change score from baseline (week 0) to post-intervention (week 9) on ATQ
    Secondary Outcome Measure Information:
    Title
    Sleep Quality
    Description
    Baseline to post-intervention or waitlist sleep change score
    Time Frame
    Change score from baseline (week 0) to post-intervention (week 9) on sleep
    Title
    Stress Reactivity
    Description
    Change score from baseline to post intervention or waitlist on heart rate/pulse
    Time Frame
    Change score from baseline (week 0) to post-intervention (week 9) in beats per minute
    Title
    Five Factor Mindfulness Questionnaire (FFMQ)
    Description
    Change in FFMQ score from baseline to post-intervention or waitlist
    Time Frame
    Change score from baseline (week 0), post-intervention (week 9) on FFMQ
    Title
    Stress reactivity
    Description
    Change score from baseline to post intervention or waitlist on BP
    Time Frame
    Change score from baseline (week 0) to post-intervention (week 9) blood pressure (BP) sys/dia measurement
    Title
    Self-report stress on behavioral tasks
    Description
    Change from baseline to post-intervention or waitlist on self-reported stress following behavioral tasks
    Time Frame
    Change score from baseline (week 0) to post-intervention (week 9) on self-rated stress (0-10 likert scale)
    Title
    Perceived Stress Scale (PSS)
    Description
    Baseline to post-intervention or waitlist PSS change score
    Time Frame
    Change score from baseline (week 0) to post-intervention (week 9) on PSS

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joel Nigg, PhD
    Organizational Affiliation
    OHSU, Psychiatry
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Stress Reduction: A Pilot Study With Adolescents

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