HealthyPhase 2NCT00179530
The Effect of Relaxation Response Training on Declarative Memory and Salivary Cortisol in Older Adults
A Phase 2 study testing Relaxation Response in people with Healthy, run by Beth Israel Deaconess Medical Center.
Trial summary
To evaluate whether a 5-week relaxation response intervention influences the learning, memory or attention of healthy older adults. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy 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
- 16 participants
- Where
- No sites listed yet
- Study dates
- May 1999to 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 to 80 years od age
- No prior or current psychiatric or neurological condition.
- score above 24 on the Mini-Mental State Exam (MMSE)
Who cannot join
None listed.
About this study
To evaluate whether a 5-week relaxation response intervention influences the learning, memory or attention of healthy older adults.
- 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.
Evaluate whether a RR training program would decrease anxiety levels, improve attention, declarative memory performance in healthy older adults.
Measured: 8 weeks
Secondary outcomes (1)
Evaluate whether a RR training program would decrease salivary cortisol levels in healthy older adults.
Measured: 8 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 startMay 1999
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 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
- NCT00179530
- Sponsor's protocol ID
- 2001-P-002249
- 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 Salivary Cortisol in Older Adults
- ClinicalTrials.gov ID
- NCT00179530
- Acronym / sponsor ID
- 2001-P-002249
- Conditions
- Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- May 1999
- 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.
To evaluate whether a 5-week relaxation response intervention influences the learning, memory or attention of healthy older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 to 80 years od age
- No prior or current psychiatric or neurological condition.
- score above 24 on the Mini-Mental State Exam (MMSE)
Key exclusion criteria (0 listed)
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
Evaluate whether a RR training program would decrease anxiety levels, improve attention, declarative memory performance in healthy older adults.
Time frame: 8 weeks
1 secondary outcome
Evaluate whether a RR training program would decrease salivary cortisol levels in healthy older adults.
Time frame: 8 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.
Related trials for Healthy
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
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 3 inclusion and 0 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?
Evaluate whether a RR training program would decrease anxiety levels, improve attention, declarative memory performance in healthy older adults. (time frame: 8 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.