Psychological Stress Clinical Trial
Official title:
Stress Reduction: A Pilot Study With Adolescents
NCT number | NCT02629016 |
Other study ID # | IRB00011301 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | June 2016 |
Verified date | January 2023 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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: - |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University |
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 |
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