CancerPhase 1mbsrNCT01599143
Identifying Therapeutic Factors in an 8-Week (30 Hour) Mindfulness-Based Stress Reduction (MBSR) Program
A Phase 1 study testing Teaching Mindfulness-based Stress Reduction strategies in people with Cancer and Diabetes, run by North York General Hospital.
Trial summary
Since it's introduction in 1979 at the University of Massachusetts Medical Center by Dr. Jon Kabat-Zinn, Mindfulness-Based Stress Reduction (MBSR) has become a respected adjunct to conventional treatment for patients suffering from many diverse chronic ailments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Diabetes, Hypertension
- What is being tested?
- Teaching Mindfulness-based Stress Reduction strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Apr 2012
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years old
- suffer from a chronic health problem
- referred by their physician
Who cannot join
- acute illness (physical or psychiatric)
- suicidal
- problem use of alcohol or other substances
- inability to do one hour of daily homework
- inability to attend all 8 sessions
About this study
Since it's introduction in 1979 at the University of Massachusetts Medical Center by Dr. Jon Kabat-Zinn, Mindfulness-Based Stress Reduction (MBSR) has become a respected adjunct to conventional treatment for patients suffering from many diverse chronic ailments. Three decades of research have documented it's benefits, but few papers have focused on identifying which particular aspect of MBSR directly correlates with it's degree of therapeutic efficacy. This study will use 7 well validated questionnaires to compare participants responses prior to, and following completion of an eight-week MBSR program at the North York General Hospital, as well as follow-up results at 1 month and 1 year post completion of the MBSR group.
Read the detailed description
As above
- Conditions
- Cancer, Diabetes, Hypertension
- Being tested
- Teaching Mindfulness-based Stress Reduction strategies
- Keywords
- Mindfulness, Pain Disorder (Chronic physical or mental health complaints:, Fibromyalgia; Migraines; Back Pain; etc), Anxiety Disorder/Anxiety State
- Medical subject headings
- Neoplasms, Diabetes Mellitus, Hypertension, Somatoform Disorders, Fibromyalgia, Migraine Disorders, Back Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teaching Mindfulness-based Stress Reduction strategiesBehavioural
Also called MBSR
Daily meditation, Hatha yoga,and cognitive restructuring
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Stress Reduction group | Experimental | All eligible participants attend a 3-hour weekly session, for 8 consecutive weeks, to learn meditation and simple Hatha Yoga techniques, and incorporate them into their daily lives. Receives: Behavioral: Teaching Mindfulness-based Stress Reduction strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSS-10
Patients' Stress Scores on the PSS-10 are used to assess self-reported perceptions of stress at baseline, at 8 weeks when the intervention ends, and again at one month and one year follow-up (to see if any change is sustained).
Measured: baseline, 8 weeks and follow-ups at 1 month and 1 year
Secondary outcomes (1)
Toronto Mindfulness Scale (TMS)
Measure of patients' self-reported capacity for detached curiosity / decentering (aspects of mindfulness), prior to intervention, at the end of the intervention (8 weeks), and at short-term (one month)and long-term (one year) follow-up.
Measured: Baseline, 8 weeks and follow up at 1 month and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startJan 2009
- Primary completionMar 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- North York General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Katalin Margittai, North York General Hospital
- Investigators
- Katalin J Margittai, MD, Principal investigator, North York General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599143
- Sponsor's protocol ID
- NYGH REB # 09-0041
- Acronym
- mbsr
- Status last verified
- May 2012
- First submitted
- 30 Apr 2012
- Last updated
- 15 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Therapeutic Factors in an 8-Week (30 Hour) Mindfulness-Based Stress Reduction (MBSR) Program
- ClinicalTrials.gov ID
- NCT01599143
- Acronym / sponsor ID
- mbsr / NYGH REB # 09-0041
- Conditions
- Cancer, Diabetes, Hypertension
- Keywords
- Mindfulness, Pain Disorder (Chronic physical or mental health complaints:, Fibromyalgia; Migraines; Back Pain; etc), Anxiety Disorder/Anxiety State
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- North York General HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 15 May 2012 (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.
Since it's introduction in 1979 at the University of Massachusetts Medical Center by Dr. Jon Kabat-Zinn, Mindfulness-Based Stress Reduction (MBSR) has become a respected adjunct to conventional treatment for patients suffering from many diverse chronic ailments. Three decades of research have documented it's benefits, but few papers have focused on identifying which particular aspect of MBSR directly correlates with it's degree of therapeutic efficacy. This study will use 7 well validated questionnaires to compare participants responses prior to, and following completion of an eight-week MBSR program at the North York General Hospital, as well as follow-up results at 1 month and 1 year post completion of the MBSR group.
Detailed description
As above
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Stress Reduction group | Experimental | Behavioral: Teaching Mindfulness-based Stress Reduction strategiesAll eligible participants attend a 3-hour weekly session, for 8 consecutive weeks, to learn meditation and simple Hatha Yoga techniques, and incorporate them into their daily lives. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over 18 years old
- suffer from a chronic health problem
- referred by their physician
Key exclusion criteria (5 listed)
- acute illness (physical or psychiatric)
- suicidal
- problem use of alcohol or other substances
- inability to do one hour of daily homework
- inability to attend all 8 sessions
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 |
|---|---|---|
| Teaching Mindfulness-based Stress Reduction strategiesAlso: MBSRDaily meditation, Hatha yoga,and cognitive restructuring | Behavioural | Mindfulness-based Stress Reduction group |
Primary outcome
PSS-10
Time frame: baseline, 8 weeks and follow-ups at 1 month and 1 year
Patients' Stress Scores on the PSS-10 are used to assess self-reported perceptions of stress at baseline, at 8 weeks when the intervention ends, and again at one month and one year follow-up (to see if any change is sustained).
1 secondary outcome
Toronto Mindfulness Scale (TMS)
Time frame: Baseline, 8 weeks and follow up at 1 month and 1 year
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 May 2012.
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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.
Katalin J Margittai, MD principal investigator
North York General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Teaching Mindfulness-based Stress Reduction strategies in people with Cancer and Diabetes, run by North York General Hospital.
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 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 15 May 2012. 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 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.
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?
PSS-10 (time frame: baseline, 8 weeks and follow-ups at 1 month and 1 year). 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 15 May 2012.