Stress Reduction: A Pilot Study With Adolescents

Psychological Stress Clinical Trial

Official title:

Stress Reduction: A Pilot Study With Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02629016
• Other study ID #: IRB00011301
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: January 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Physiological Stress
• Psychological Stress
• Stress, Psychological

Intervention

Other:
• Mindfulness

• Wellness

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	Sleep Quality	Baseline to post-intervention or waitlist sleep change score	Change score from baseline (week 0) to post-intervention (week 9) on sleep
Secondary	Stress Reactivity	Change score from baseline to post intervention or waitlist on heart rate/pulse	Change score from baseline (week 0) to post-intervention (week 9) in beats per minute
Secondary	Five Factor Mindfulness Questionnaire (FFMQ)	Change in FFMQ score from baseline to post-intervention or waitlist	Change score from baseline (week 0), post-intervention (week 9) on FFMQ
Secondary	Stress reactivity	Change score from baseline to post intervention or waitlist on BP	Change score from baseline (week 0) to post-intervention (week 9) blood pressure (BP) sys/dia measurement
Secondary	Self-report stress on behavioral tasks	Change from baseline to post-intervention or waitlist on self-reported stress following behavioral tasks	Change score from baseline (week 0) to post-intervention (week 9) on self-rated stress (0-10 likert scale)
Secondary	Perceived Stress Scale (PSS)	Baseline to post-intervention or waitlist PSS change score	Change score from baseline (week 0) to post-intervention (week 9) on PSS