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
About this trial
This is an interventional other trial for Physiological Stress
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:
-
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
NCT ID
NCT02629016
First Posted
December 8, 2015
Last Updated
January 23, 2023
Sponsor
Oregon Health and Science University
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
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Stress Reduction: A Pilot Study With Adolescents
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