HealthyPhase 2NCT00179504
The Effect of Relaxation Response Training on Declarative Memory and Learning in High School Students
A Phase 2 study testing Relaxation Response in people with Healthy, run by Beth Israel Deaconess Medical Center.
Trial summary
Stress contributes to health and behavioral issues in students, but will not be integrated into schools without evidence of benefit. This study was conducted to determine if a 6-week relaxation response (RR) curriculum improves cognitive performance in ninth grade students. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Relaxation Response
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jul 2000to Sep 2007
- Phase
- Phase 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- a member of 9th grade at a residential preparatory school.
Who cannot join
- none
About this study
Stress contributes to health and behavioral issues in students, but will not be integrated into schools without evidence of benefit. This study was conducted to determine if a 6-week relaxation response (RR) curriculum improves cognitive performance in ninth grade students.
Read the detailed description
Stress contributes to health and behavioral issues in students, but will not be integrated into schools without evidence of benefit. This study was conducted to determine if a 6-week relaxation response (RR) curriculum improves cognitive performance in ninth grade students.
- Conditions
- Healthy
- Being tested
- Relaxation Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation ResponseBehavioural
Relaxation training
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if a 6-week relaxation response (RR) curriculum improves cognitive performance.
Measured: 6 weeks
Secondary outcomes (1)
Evaluate whether the program would influence levels of salivary cortisol and whether there would be a correlation between cortisol levels and performance on the cognitive tasks.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2000
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jeffery A Dusek, PhD, Principal investigator, Beth Israel Deaconess Medical Center, Mind/Body Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179504
- Sponsor's protocol ID
- 2001-P-000110
- Status last verified
- Nov 2007
- First submitted
- 13 Sep 2005
- Last updated
- 5 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Relaxation Response Training on Declarative Memory and Learning in High School Students
- ClinicalTrials.gov ID
- NCT00179504
- Acronym / sponsor ID
- 2001-P-000110
- Conditions
- Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jul 2000
- Study completion
- Sep 2007 (actual)
- First posted
- 16 Sep 2005 (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.
Stress contributes to health and behavioral issues in students, but will not be integrated into schools without evidence of benefit. This study was conducted to determine if a 6-week relaxation response (RR) curriculum improves cognitive performance in ninth grade students.
Detailed description
Stress contributes to health and behavioral issues in students, but will not be integrated into schools without evidence of benefit. This study was conducted to determine if a 6-week relaxation response (RR) curriculum improves cognitive performance in ninth grade students.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- a member of 9th grade at a residential preparatory school.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Relaxation ResponseRelaxation training | Behavioural | – |
Primary outcome
Determine if a 6-week relaxation response (RR) curriculum improves cognitive performance.
Time frame: 6 weeks
1 secondary outcome
Evaluate whether the program would influence levels of salivary cortisol and whether there would be a correlation between cortisol levels and performance on the cognitive tasks.
Time frame: 6 weeks
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 5 Nov 2007.
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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.
Jeffery A Dusek, PhD principal investigator
Beth Israel Deaconess Medical Center, Mind/Body Medical Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Relaxation Response in people with Healthy, run by Beth Israel Deaconess Medical Center.
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 5 Nov 2007. 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 phase mean?
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?
Determine if a 6-week relaxation response (RR) curriculum improves cognitive performance. (time frame: 6 weeks). 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 5 Nov 2007.