Physiological StressNCT02629016
Stress Reduction: A Pilot Study With Adolescents
A study testing Mindfulness and Wellness in people with Physiological Stress and Psychological Stress, run by Oregon Health and Science University.
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. Read more about this study
- Who is it for?
- Ages 14 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiological Stress, Psychological Stress
- What is being tested?
- Mindfulness and Wellness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Intellectual disability, as reported by parent or teacher;
- Current manic episode
- Psychotic episode
- Untreated Post Traumatic Stress Disorder, identified through parent or student report.
- -
About this study
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.
Read the 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.
- Conditions
- Physiological Stress, Psychological Stress
- Being tested
- Mindfulness, Wellness
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessOther
WellnessOther
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Education and experiential exercises for mindfulness including movement, thoughts and meditation Receives: Other: Mindfulness |
| Wellness | Active comparator | Education and experiential exercises for general wellness including sleep hygiene, goal setting and power poses. Receives: Other: Wellness |
| Waitlist | No intervention | Students receive regular health class instruction without intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Anxiety and Stress Scale (DASS)
Baseline to post-intervention or waitlist DASS change score
Measured: 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
Measured: 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
Measured: Change score from baseline (week 0) to post-intervention (week 9) on ATQ
Secondary outcomes (6)
Sleep Quality
Baseline to post-intervention or waitlist sleep change score
Measured: Change score from baseline (week 0) to post-intervention (week 9) on sleep
Stress Reactivity
Change score from baseline to post intervention or waitlist on heart rate/pulse
Measured: Change score from baseline (week 0) to post-intervention (week 9) in beats per minute
Five Factor Mindfulness Questionnaire (FFMQ)
Change in FFMQ score from baseline to post-intervention or waitlist
Measured: Change score from baseline (week 0), post-intervention (week 9) on FFMQ
Stress reactivity
Change score from baseline to post intervention or waitlist on BP
Measured: Change score from baseline (week 0) to post-intervention (week 9) blood pressure (BP) sys/dia measurement
Self-report stress on behavioral tasks
Change from baseline to post-intervention or waitlist on self-reported stress following behavioral tasks
Measured: Change score from baseline (week 0) to post-intervention (week 9) on self-rated stress (0-10 likert scale)
Perceived Stress Scale (PSS)
Baseline to post-intervention or waitlist PSS change score
Measured: Change score from baseline (week 0) to post-intervention (week 9) on PSS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeanette Johnstone, Oregon Health and Science University
- Investigators
- Joel Nigg, PhD, Principal investigator, OHSU, Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629016
- Sponsor's protocol ID
- IRB00011301
- Status last verified
- Jan 2023
- First submitted
- 8 Dec 2015
- Last updated
- 25 Jan 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Reduction: A Pilot Study With Adolescents
- ClinicalTrials.gov ID
- NCT02629016
- Acronym / sponsor ID
- IRB00011301
- Conditions
- Physiological Stress, Psychological Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Other: MindfulnessEducation and experiential exercises for mindfulness including movement, thoughts and meditation |
| Wellness | Active comparator | Other: WellnessEducation and experiential exercises for general wellness including sleep hygiene, goal setting and power poses. |
| Waitlist | No intervention | –Students receive regular health class instruction without intervention. |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- Intellectual disability, as reported by parent or teacher;
- Current manic episode
- Psychotic episode
- Untreated Post Traumatic Stress Disorder, identified through parent or student report.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness | Other | Mindfulness |
| Wellness | Other | Wellness |
Primary outcome
Depression Anxiety and Stress Scale (DASS)
Time frame: Change in DASS score from baseline (week 0) to post-intervention (week 9)
Baseline to post-intervention or waitlist DASS change score
Conners 3 Short Form
Time frame: Change score from baseline (week 0) to post-intervention (week 9) on Conners
Baseline to post-intervention or waitlist Conners change score
Automatic Thoughts Questionnaires (ATQ)
Time frame: Change score from baseline (week 0) to post-intervention (week 9) on ATQ
Baseline to post-intervention or waitlist ATQ change score
6 secondary outcomes
Sleep Quality
Time frame: Change score from baseline (week 0) to post-intervention (week 9) on sleep
Stress Reactivity
Time frame: Change score from baseline (week 0) to post-intervention (week 9) in beats per minute
Five Factor Mindfulness Questionnaire (FFMQ)
Time frame: Change score from baseline (week 0), post-intervention (week 9) on FFMQ
Stress reactivity
Time frame: Change score from baseline (week 0) to post-intervention (week 9) blood pressure (BP) sys/dia measurement
Self-report stress on behavioral tasks
Time frame: Change score from baseline (week 0) to post-intervention (week 9) on self-rated stress (0-10 likert scale)
Perceived Stress Scale (PSS)
Time frame: Change score from baseline (week 0) to post-intervention (week 9) on PSS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Nigg, PhD principal investigator
OHSU, Psychiatry
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and Wellness in people with Physiological Stress and Psychological Stress, run by Oregon Health and Science University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression Anxiety and Stress Scale (DASS) (time frame: Change in DASS score from baseline (week 0) to post-intervention (week 9)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.