Stress Reduction: A Pilot Study With Adolescents

NCT02629016 | Completed

• 1 other identifier: IRB00011301
• Study Type: interventional
• Target: 285
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Physiological Stress; Psychological Stress

Outcome Measures

Primary Outcomes (3)

• Depression Anxiety and Stress Scale (DASS)

  Baseline to post-intervention or waitlist DASS change score

  Change in DASS score from baseline (week 0) to post-intervention (week 9)

• Conners 3 Short Form

  Baseline to post-intervention or waitlist Conners change score

  Change score from baseline (week 0) to post-intervention (week 9) on Conners

• Automatic Thoughts Questionnaires (ATQ)

  Baseline to post-intervention or waitlist ATQ change score

  Change score from baseline (week 0) to post-intervention (week 9) on ATQ

Secondary Outcomes (6)

• Sleep Quality

  Change score from baseline (week 0) to post-intervention (week 9) on sleep

• Stress Reactivity

  Change score from baseline (week 0) to post-intervention (week 9) in beats per minute

• Five Factor Mindfulness Questionnaire (FFMQ)

  Change score from baseline (week 0), post-intervention (week 9) on FFMQ

• Stress reactivity

  Change score from baseline (week 0) to post-intervention (week 9) blood pressure (BP) sys/dia measurement

• 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)

Study Arms (3)

Mindfulness

EXPERIMENTAL

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

Other: Mindfulness

Wellness

ACTIVE COMPARATOR

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

Other: Wellness

Waitlist

NO INTERVENTION

Students receive regular health class instruction without intervention.

Interventions

Mindfulness OTHER

Mindfulness

Wellness OTHER

Wellness

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Intellectual disability, as reported by parent or teacher;
• Current manic episode
• Psychotic episode
• Untreated Post Traumatic Stress Disorder, identified through parent or student report.

Sponsors & Collaborators

• Oregon Health and Science University: lead

MeSH Terms

Conditions

Stress, Psychological

Interventions

Mindfulness; Health

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Population Characteristics

Study Officials

• Joel Nigg, PhD

  OHSU, Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 11, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 25, 2023

Record last verified: 2023-01