Clinical trial NCT02629016: Stress Reduction: A Pilot Study With Adolescents
Official title: Stress Reduction: A Pilot Study With Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physiological Stress
Psychological Stress
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 285
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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:

-

Primary outcomes:
measure: Depression Anxiety and Stress Scale (DASS)
timeFrame: Change in DASS score from baseline (week 0) to post-intervention (week 9)
measure: Conners 3 Short Form
timeFrame: Change score from baseline (week 0) to post-intervention (week 9) on Conners
measure: Automatic Thoughts Questionnaires (ATQ)
timeFrame: Change score from baseline (week 0) to post-intervention (week 9) on ATQ
Secondary outcomes:
measure: Sleep Quality
timeFrame: Change score from baseline (week 0) to post-intervention (week 9) on sleep
measure: Stress Reactivity
timeFrame: Change score from baseline (week 0) to post-intervention (week 9) in beats per minute
measure: Five Factor Mindfulness Questionnaire (FFMQ)
timeFrame: Change score from baseline (week 0), post-intervention (week 9) on FFMQ
measure: Stress reactivity
timeFrame: Change score from baseline (week 0) to post-intervention (week 9) blood pressure (BP) sys/dia measurement
measure: Self-report stress on behavioral tasks
timeFrame: Change score from baseline (week 0) to post-intervention (week 9) on self-rated stress (0-10 likert scale)
measure: Perceived Stress Scale (PSS)
timeFrame: Change score from baseline (week 0) to post-intervention (week 9) on PSS
Other outcomes:
Locations:
Study officials:
affiliation: OHSU, Psychiatry
name: Joel Nigg, PhD
role: PRINCIPAL_INVESTIGATOR
References: