AnxietyPhase 1/2NCT02339363
Effects of Sitting Meditation and Hatha Yoga in Adolescents
A Phase 1/2 study testing Sitting Meditation and Hatha yoga in people with Anxiety and Psychological Stress, run by Alliant International University.
Trial summary
The present study was a randomized controlled trial that explored the feasibility, acceptability, and effectiveness of short-term mindfulness training among adolescents. The primary purpose was to investigate the effectiveness of two main Mindfulness-Based Stress Reduction components-sitting meditation and hatha… Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Psychological Stress
- What is being tested?
- Sitting Meditation and Hatha yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Jul 2013
- Phase
- Phase 1/2
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students currently enrolled in school
- Between the ages of 12 - 17 years old
- English speaking-to understand and complete the measures
- Able to attend the weekly hatha yoga or sitting meditation sessions
- Not reporting any injuries or health condition(s) that might limit their physical activity
Who cannot join
- hearing impairments, injuries, or physical disabilities that would hinder them from fully participating in intervention
About this study
Official title: Differential Effects of Sitting Meditation and Hatha Yoga on Working Memory, Stress, and Mindfulness Among Adolescents in a School Setting
The present study was a randomized controlled trial that explored the feasibility, acceptability, and effectiveness of short-term mindfulness training among adolescents. The primary purpose was to investigate the effectiveness of two main Mindfulness-Based Stress Reduction components-sitting meditation and hatha yoga-on working memory, stress, anxiety and mindfulness. The influence of daily home practice compliance on intervention outcomes was also examined.
Read the detailed description
The present study was a randomized controlled trial that explored the feasibility, acceptability, and effectiveness of short-term mindfulness training among adolescents. The primary purpose was to investigate the effectiveness of two main Mindfulness-Based Stress Reduction components-sitting meditation and hatha yoga-on working memory, stress, anxiety and mindfulness. The influence of daily home practice compliance on intervention outcomes was also examined. Participants (N = 198 adolescents) were recruited from a large public middle school in southern California. Participants were randomly assigned to sitting meditation, hatha yoga, or a waitlist control group. Participants were asked to complete a computerized working memory task, and self-report measures of perceived stress, anxiety, and mindfulness at pre- and post-intervention/waitlist, as well as one-month follow-up. A series of mixed-design analyses of variance (ANOVAs) were used to examine changes in working memory, stress, anxiety, and mindfulness between groups at pre- and post- intervention.
- Conditions
- Anxiety, Psychological Stress
- Being tested
- Sitting Meditation, Hatha yoga
- Keywords
- mindfulness, adolescents, working memory, stress, anxiety
- Medical subject headings
- Anxiety Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitting MeditationBehavioural
4 weeks Sitting Meditation
Hatha yogaBehavioural
4 weeks of Hatha yoga
| Study group | Role | What they receive |
|---|---|---|
| Sitting Meditation | Experimental | 4 weeks (45-min sessions, 2x per week) of sitting meditation, based on MBSR. The sitting meditation condition consisted of three parts: (a) breathing techniques, (b) meditation, and (c) discussion. Participants in the sitting meditation group learned new types of sitting meditation each week. Participants in the sitting meditation group received a CD that consisted of audio meditations that they could follow along at home. The sitting meditation participants were encouraged to practice formal sitting meditation for 15 to 30 minutes every day and asked to record details of their practice on their daily home practice logs. Receives: Behavioral: Sitting Meditation |
| Hatha Yoga | Experimental | 4 weeks(45-min sessions, 2x per week) of Hatha Yoga. The adolescent hatha yoga curriculum was used with permission from Shanti Generation Yoga © (2009) created by Abby Wills. The hatha yoga sessions consisted of three parts: (a) breathing techniques, (b) yoga poses, and (c) discussion. Participants in the hatha yoga group learned a series of new yoga poses each week, as well as reviewed old poses. During the first session, participants in the hatha yoga group received a DVD that contained five yoga lessons corresponding to the yoga poses being taught in the intervention. Participants were encouraged to practice the series of yoga poses at home for 15 to 30 minutes each day and record their home practice in their daily home practice logs. Receives: Behavioral: Hatha yoga |
| Waitlist Control | No intervention | 4-week waitlist control condition. Completed all study measures at same time points as experimental groups. Were randomly assigned to one of the two active treatment conditions after completing the waitlist period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working Memory Capacity: Automated Operational Span Task (AOSPAN)
Participants completed the AOSPAN prior to beginning their group condition (sitting meditation, Hatha yoga, or waitlist control) and again at the end of the 4-week intervention (waitlist) period.
Measured: pre-intervention and post-intervention (waitlist), t the end of the 4-week intervention (waitlist) period
Secondary outcomes (3)
Stress: Perceived Stress Scale (PSS-10)
Participants completed the PSS-10 prior to beginning their group condition (sitting meditation, Hatha yoga, or waitlist control) and again at the end of the 4-week intervention (waitlist) period.
Measured: pre-intervention and post-intervention (waitlist), t the end of the 4-week intervention (waitlist) period
Anxiety: Screen for Child Anxiety and Related Emotional Disorders (SCARED)
Participants completed the SCARED prior to beginning their group condition (sitting meditation, Hatha yoga, or waitlist control) and again at the end of the 4-week intervention (waitlist) period.
Measured: pre-intervention and post-intervention, t the end of the 4-week intervention (waitlist) period
Mindfulness: Child Acceptance and Mindfulness Measure (CAMM)
Participants completed the CAMM prior to beginning their group condition (sitting meditation, Hatha yoga, or waitlist control) and again at the end of the 4-week intervention (waitlist) period.
Measured: pre-intervention and post-intervention (waitlist), t the end of the 4-week intervention (waitlist) period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliant International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen Jastrowski Mano, Alliant International University
- Investigators
- Kristen Jastrowski Mano, Ph.D., Principal investigator, Alliant International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339363
- Sponsor's protocol ID
- Quach-1-2013
- Status last verified
- Jan 2015
- First submitted
- 9 Jan 2015
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Quach D, Jastrowski Mano KE, Alexander K. A Randomized Controlled Trial Examining the Effect of Mindfulness Meditation on Working Memory Capacity in Adolescents. J Adolesc Health. 2016 May;58(5):489-96. doi: 10.1016/j.jadohealth.2015.09.024. Epub 2015 Nov 11.
PubMed 26576819
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effects of Sitting Meditation and Hatha Yoga on Working Memory, Stress, and Mindfulness Among Adolescents in a School Setting
- ClinicalTrials.gov ID
- NCT02339363
- Acronym / sponsor ID
- Quach-1-2013
- Conditions
- Anxiety, Psychological Stress
- Keywords
- mindfulness, adolescents, working memory, stress, anxiety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Alliant International UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Jan 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.
The present study was a randomized controlled trial that explored the feasibility, acceptability, and effectiveness of short-term mindfulness training among adolescents. The primary purpose was to investigate the effectiveness of two main Mindfulness-Based Stress Reduction components-sitting meditation and hatha yoga-on working memory, stress, anxiety and mindfulness. The influence of daily home practice compliance on intervention outcomes was also examined.
Detailed description
The present study was a randomized controlled trial that explored the feasibility, acceptability, and effectiveness of short-term mindfulness training among adolescents. The primary purpose was to investigate the effectiveness of two main Mindfulness-Based Stress Reduction components-sitting meditation and hatha yoga-on working memory, stress, anxiety and mindfulness. The influence of daily home practice compliance on intervention outcomes was also examined. Participants (N = 198 adolescents) were recruited from a large public middle school in southern California. Participants were randomly assigned to sitting meditation, hatha yoga, or a waitlist control group. Participants were asked to complete a computerized working memory task, and self-report measures of perceived stress, anxiety, and mindfulness at pre- and post-intervention/waitlist, as well as one-month follow-up. A series of mixed-design analyses of variance (ANOVAs) were used to examine changes in working memory, stress, anxiety, and mindfulness between groups at pre- and post- intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sitting Meditation | Experimental | Behavioral: Sitting Meditation4 weeks (45-min sessions, 2x per week) of sitting meditation, based on MBSR. The sitting meditation condition consisted of three parts: (a) breathing techniques, (b) meditation, and (c) discussion. Participants in the sitting meditation group learned new types of sitting meditation each week. Participants in the sitting meditation group received a CD that consisted of audio meditations that they could follow along at home. The sitting meditation participants were encouraged to practice formal sitting meditation for 15 to 30 minutes every day and asked to record details of their practice on their daily home practice logs. |
| Hatha Yoga | Experimental | Behavioral: Hatha yoga4 weeks(45-min sessions, 2x per week) of Hatha Yoga. The adolescent hatha yoga curriculum was used with permission from Shanti Generation Yoga © (2009) created by Abby Wills. The hatha yoga sessions consisted of three parts: (a) breathing techniques, (b) yoga poses, and (c) discussion. Participants in the hatha yoga group learned a series of new yoga poses each week, as well as reviewed old poses. During the first session, participants in the hatha yoga group received a DVD that contained five yoga lessons corresponding to the yoga poses being taught in the intervention. Participants were encouraged to practice the series of yoga poses at home for 15 to 30 minutes each day and record their home practice in their daily home practice logs. |
| Waitlist Control | No intervention | –4-week waitlist control condition. Completed all study measures at same time points as experimental groups. Were randomly assigned to one of the two active treatment conditions after completing the waitlist period. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Students currently enrolled in school
- Between the ages of 12 - 17 years old
- English speaking-to understand and complete the measures
- Able to attend the weekly hatha yoga or sitting meditation sessions
- Not reporting any injuries or health condition(s) that might limit their physical activity
Key exclusion criteria (1 listed)
- hearing impairments, injuries, or physical disabilities that would hinder them from fully participating in intervention
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 |
|---|---|---|
| Sitting Meditation4 weeks Sitting Meditation | Behavioural | Sitting Meditation |
| Hatha yoga4 weeks of Hatha yoga | Behavioural | Hatha Yoga |
Primary outcome
Working Memory Capacity: Automated Operational Span Task (AOSPAN)
Time frame: pre-intervention and post-intervention (waitlist), t the end of the 4-week intervention (waitlist) period
Participants completed the AOSPAN prior to beginning their group condition (sitting meditation, Hatha yoga, or waitlist control) and again at the end of the 4-week intervention (waitlist) period.
3 secondary outcomes
Stress: Perceived Stress Scale (PSS-10)
Time frame: pre-intervention and post-intervention (waitlist), t the end of the 4-week intervention (waitlist) period
Anxiety: Screen for Child Anxiety and Related Emotional Disorders (SCARED)
Time frame: pre-intervention and post-intervention, t the end of the 4-week intervention (waitlist) period
Mindfulness: Child Acceptance and Mindfulness Measure (CAMM)
Time frame: pre-intervention and post-intervention (waitlist), t the end of the 4-week intervention (waitlist) period
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 15 Jan 2015.
- Derived from this study: PubMed 26576819Quach D, Jastrowski Mano KE, Alexander K. A Randomized Controlled Trial Examining the Effect of Mindfulness Meditation on Working Memory Capacity in Adolescents. J Adolesc Health. 2016 May;58(5):489-96. doi: 10.1016/j.jadohealth.2015.09.024. Epub 2015 Nov 11.
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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.
Kristen Jastrowski Mano, Ph.D. principal investigator
Alliant International University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sitting Meditation and Hatha yoga in people with Anxiety and Psychological Stress, run by Alliant International 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 5 inclusion and 1 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 15 Jan 2015. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Working Memory Capacity: Automated Operational Span Task (AOSPAN) (time frame: pre-intervention and post-intervention (waitlist), t the end of the 4-week intervention (waitlist) period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02339363, which also lists 1 linked publication.
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 15 Jan 2015.