AnxietyNCT03718845
A Mind-Body Medicine Curriculum for Peer Counselors
An observational study of Anxiety, run by The Center for Mind-Body Medicine at 1 site in United States.
Trial summary
This study will evaluate a Mind-Body Medicine curriculum for high school peer counselors in order to answer the following research questions: 1. Will peer counselor participation in the Mind-Body Medicine curriculum increase their sense of self-regulation, responsibility, social competence, and empathy; decrease… Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Mind-Body Medicine Curriculum
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2018to 30 Jun 2019
- Phase
- Observational
- 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 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: High school students who are participating in the Peer Counseling Program at Marjory Stoneman Douglas High School
Who may be able to join
- All high school students who are participating in the Peer Counseling Program at Marjory Stoneman Douglas High School
Who cannot join
- None (as long as the students meet the inclusion criteria)
Trial locations and contacts
1 site in 1 country.
United States1 site
Marjory Stoneman Douglas High School
Parkland, Florida, 33076
About this study
Official title: Evaluation of a Mind-Body Medicine Curriculum for High School Peer Counselors
This study will evaluate a Mind-Body Medicine curriculum for high school peer counselors in order to answer the following research questions:
- Will peer counselor participation in the Mind-Body Medicine curriculum increase their sense of self-regulation, responsibility, social competence, and empathy; decrease anxiety; and increase hope?
- What are the experiences of peer support counselors participating in the Mind-Body Medicine curriculum?
Read the detailed description
The study will be done at the Marjory Stoneman Douglas High School. The research will use a mixed-methods design by collecting both quantitative and qualitative data. The quantitative data will be in the form of standardized research instruments and the qualitative data will be gathered through focus group interviews with the peer-counselors.
- Conditions
- Anxiety
- Being tested
- Mind-Body Medicine Curriculum
- Keywords
- Empathy, Hope
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body Medicine CurriculumBehavioural
Also called Mind-Body Skills Groups
The Mind-Body Medicine curriculum consists of presentations on different mind-body techniques as well as the research supporting the use of these techniques.The mind-body technique is then practiced in a supportive small group setting. Mind-body techniques will include guided imagery, relaxation techniques, several forms of meditation, autogenic training and biofeedback.
| Study group | Role | What they receive |
|---|---|---|
| Peer Counselors | Mind-Body Medicine Curriculum Receives: Behavioral: Mind-Body Medicine Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State-Trait Anxiety Inventory (STAI) scores
The State-Trait Anxiety Inventory has two subscales: State Anxiety and Trait Anxiety. Each has a minimum score of 20 and a maximum score of 80. Higher scores indicate more anxiety which is a worse outcome.
Measured: baseline, approximately 2 months, approximately 8 months
Secondary outcomes (2)
Change in the Social Emotional Assets and Resilience Scales for Adolescents (SEARS-A)
The Social Emotional Assets and Resilience Scales for Adolescents (SEARS-A) has a total score and four subscales. The score ranges are as follows: Total Score 0-105; Self-Regulation 0-24; Social Competence 0-30; Empathy 0-33; Responsibility 0-18. Lower scores indicate a worse outcome. Subscales are summed to obtain the total score.
Measured: baseline, approximately 2 months, approximately 8 months
Change in the Adult Hope Scale
The Adult Hope Scale has a total score and 2 subscales. The score ranges are as follows: Total Score 8-24; Agency subscale 4-32; Pathways subscale 4-32. Lower scores indicate a worse outcome. Subscales are summed to obtain the total score.
Measured: baseline, approximately 2 months, approximately 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start22 Oct 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Mind-Body Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Silicon Valley Community Foundation
- Responsible party
- Principal investigator, James S. Gordon, M.D., The Center for Mind-Body Medicine
- Investigators
- James S Gordon, MD, Principal investigator, The Center for Mind-Body Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718845
- Sponsor's protocol ID
- BCPS-001
- Status last verified
- Aug 2022
- First submitted
- 8 Oct 2018
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Mind-Body Medicine Curriculum for High School Peer Counselors
- ClinicalTrials.gov ID
- NCT03718845
- Acronym / sponsor ID
- BCPS-001
- Conditions
- Anxiety
- Keywords
- Empathy, Hope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- The Center for Mind-Body MedicineUniversity, hospital or other
- Collaborators
- Silicon Valley Community Foundation
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 25 Oct 2018 (actual)
- 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 a Mind-Body Medicine curriculum for high school peer counselors in order to answer the following research questions:
- Will peer counselor participation in the Mind-Body Medicine curriculum increase their sense of self-regulation, responsibility, social competence, and empathy; decrease anxiety; and increase hope?
- What are the experiences of peer support counselors participating in the Mind-Body Medicine curriculum?
Detailed description
The study will be done at the Marjory Stoneman Douglas High School. The research will use a mixed-methods design by collecting both quantitative and qualitative data. The quantitative data will be in the form of standardized research instruments and the qualitative data will be gathered through focus group interviews with the peer-counselors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peer Counselors | – | Behavioral: Mind-Body Medicine CurriculumMind-Body Medicine Curriculum |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- High school students who are participating in the Peer Counseling Program at Marjory Stoneman Douglas High School
Key inclusion criteria (1 listed)
- All high school students who are participating in the Peer Counseling Program at Marjory Stoneman Douglas High School
Key exclusion criteria (1 listed)
- None (as long as the students meet the inclusion criteria)
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 |
|---|---|---|
| Mind-Body Medicine CurriculumAlso: Mind-Body Skills GroupsThe Mind-Body Medicine curriculum consists of presentations on different mind-body techniques as well as the research supporting the use of these techniques.The mind-body technique is then practiced in a supportive small group setting. Mind-body techniques will include guided imagery, relaxation techniques, several forms of meditation, autogenic training and biofeedback. | Behavioural | Peer Counselors |
Primary outcome
Change in State-Trait Anxiety Inventory (STAI) scores
Time frame: baseline, approximately 2 months, approximately 8 months
The State-Trait Anxiety Inventory has two subscales: State Anxiety and Trait Anxiety. Each has a minimum score of 20 and a maximum score of 80. Higher scores indicate more anxiety which is a worse outcome.
2 secondary outcomes
Change in the Social Emotional Assets and Resilience Scales for Adolescents (SEARS-A)
Time frame: baseline, approximately 2 months, approximately 8 months
Change in the Adult Hope Scale
Time frame: baseline, approximately 2 months, approximately 8 months
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 31 Aug 2022.
- The Center for Mind-Body Medicine websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
James S Gordon, MD principal investigator
The Center for Mind-Body Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety, run by The Center for Mind-Body Medicine at 1 site in United States.
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 1 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 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in State-Trait Anxiety Inventory (STAI) scores (time frame: baseline, approximately 2 months, approximately 8 months). 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 31 Aug 2022.