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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

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

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

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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