Stress Reduction: A Pilot Study With Adolescents

Sponsor
Oregon Health and Science University (Other)
Overall Status
Completed
CT.gov ID
NCT02629016
Collaborator
(none)
285
3
9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mindfulness
  • Other: Wellness
N/A

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
Actual Enrollment :
285 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Stress Reduction: A Pilot Study With Adolescents
Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mindfulness

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

Other: Mindfulness

Active Comparator: Wellness

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

Other: Wellness

No Intervention: Waitlist

Students receive regular health class instruction without intervention.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Conners 3 Short Form [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) [Change score from baseline (week 0) to post-intervention (week 9) on ATQ]

    Baseline to post-intervention or waitlist ATQ change score

Secondary Outcome Measures

  1. Sleep Quality [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 [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) [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 [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 [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) [Change score from baseline (week 0) to post-intervention (week 9) on PSS]

    Baseline to post-intervention or waitlist PSS change score

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Oregon Health and Science University

Investigators

  • Principal Investigator: Joel Nigg, PhD, OHSU, Psychiatry

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Barry S. Oken, MD, MS, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT02629016
Other Study ID Numbers:
  • IRB00011301
First Posted:
Dec 11, 2015
Last Update Posted:
Oct 15, 2018
Last Verified:
Oct 1, 2018
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 15, 2018