Fibromyalgia SyndromeNCT02800720
Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome
A study testing Meditation Awareness Training and Cognitive Behavioral Therapy for Groups in people with Fibromyalgia Syndrome, run by Nottingham Trent University.
Trial summary
A Randomised Controlled Trial to evaluate the effectiveness of a Second-Generation Mindfulness-Based Intervention known as Meditation Awareness Training (MAT) for treating fibromyalgia syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia Syndrome
- What is being tested?
- Meditation Awareness Training and Cognitive Behavioral Therapy for Groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Sep 2014
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current diagnosis of fibromyalgia syndrome
- Aged between 18 and 65 years
- Able to read and write using the English language
- Available to complete an eight-week intervention and six-month follow-up assessment
Who cannot join
- Currently undergoing formal psychotherapy
- Changes in psychopharmacology type or dosage one-month prior to intervention
- Currently practicing mindfulness or meditation
About this study
Official title: Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome: A Randomised Controlled Trial
A Randomised Controlled Trial to evaluate the effectiveness of a Second-Generation Mindfulness-Based Intervention known as Meditation Awareness Training (MAT) for treating fibromyalgia syndrome.
Read the detailed description
Background: Fibromyalgia syndrome (FMS) is a chronic pain disorder that frequently leads to poor quality of life. The need for more effective FMS treatments has prompted empirical investigations into the applications of mindfulness for treating the condition. However, studies have predominantly focused on first-generation mindfulness-based interventions (FG-MBIs). To date, a randomised controlled trial (RCT) assessing the effectiveness of a second-generation mindfulness-based intervention (SG-MBI) for treating FMS has not been undertaken. SG-MBIs are distinct from FG-MBIs because they are overtly spiritual in nature and employ (i) a greater range of (normally secularised) meditative/spiritual techniques, (ii) ethics as a key component of the taught programme, and (iii) an instructor training programme that typically requires several years of supervised mindfulness practice.
Aims: To evaluate the effectiveness of Meditation Awareness Training (MAT) - an SG-MBI - for treating FMS.
Method: Adults with FMS will receive MAT or an active control intervention known as Cognitive-Behavioural Therapy for Groups. Assessments will be performed at pre-intervention, post-intervention, and follow-up phases.
- Conditions
- Fibromyalgia Syndrome
- Being tested
- Meditation Awareness Training, Cognitive Behavioral Therapy for Groups
- Keywords
- Fibromyalgia Syndromey
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation Awareness TrainingBehavioural
8 Week Meditation Intervention
Cognitive Behavioral Therapy for GroupsBehavioural
8 week intervention based on Cognitive Behavioral Theory
| Study group | Role | What they receive |
|---|---|---|
| Meditation Awareness Training | Experimental | Target Intervention Arm:
8-week meditation intervention Receives: Behavioral: Meditation Awareness Training |
| Cognitive Behavioural Therapy for Groups | Active comparator | Active Comparator Arm:
8-week CBT-based intervention Receives: Behavioral: Cognitive Behavioral Therapy for Groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revised Fibromyalgia Impact Questionnaire
Scale Reference: Bennett, Friend, Jones, Ward, Han \& Ross (2009)
Measured: 8 weeks
Short Form McGill Pain Questionnaire
Scale Reference: Melzack (1987)
Measured: 8 weeks
Pittsburgh Sleep Quality Index
Scale Reference: Buysse, Reynolds Monk, Berman, \& Kupfer (1989)
Measured: 8 weeks
Depression Anxiety and Stress Scale
Scale Reference: Lovibond \& Lovibond (1995)
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 posted15 Jun 2016 (estimated)
- Study startNov 2012
- Primary completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham Trent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Van Gordon, Nottingham Trent University
- Investigators
- William Van Gordon, Principal investigator, Nottingham Trent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800720
- Sponsor's protocol ID
- NTU-MATFMS
- Status last verified
- Jun 2016
- First submitted
- 6 Jun 2016
- Last updated
- 15 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02800720
- Acronym / sponsor ID
- NTU-MATFMS
- Conditions
- Fibromyalgia Syndrome
- Keywords
- Fibromyalgia Syndromey
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Nottingham Trent UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2014 (actual)
- First posted
- 15 Jun 2016 (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.
A Randomised Controlled Trial to evaluate the effectiveness of a Second-Generation Mindfulness-Based Intervention known as Meditation Awareness Training (MAT) for treating fibromyalgia syndrome.
Detailed description
Background: Fibromyalgia syndrome (FMS) is a chronic pain disorder that frequently leads to poor quality of life. The need for more effective FMS treatments has prompted empirical investigations into the applications of mindfulness for treating the condition. However, studies have predominantly focused on first-generation mindfulness-based interventions (FG-MBIs). To date, a randomised controlled trial (RCT) assessing the effectiveness of a second-generation mindfulness-based intervention (SG-MBI) for treating FMS has not been undertaken. SG-MBIs are distinct from FG-MBIs because they are overtly spiritual in nature and employ (i) a greater range of (normally secularised) meditative/spiritual techniques, (ii) ethics as a key component of the taught programme, and (iii) an instructor training programme that typically requires several years of supervised mindfulness practice.
Aims: To evaluate the effectiveness of Meditation Awareness Training (MAT) - an SG-MBI - for treating FMS.
Method: Adults with FMS will receive MAT or an active control intervention known as Cognitive-Behavioural Therapy for Groups. Assessments will be performed at pre-intervention, post-intervention, and follow-up phases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditation Awareness Training | Experimental | Behavioral: Meditation Awareness TrainingTarget Intervention Arm: 8-week meditation intervention |
| Cognitive Behavioural Therapy for Groups | Active comparator | Behavioral: Cognitive Behavioral Therapy for GroupsActive Comparator Arm: 8-week CBT-based intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current diagnosis of fibromyalgia syndrome
- Aged between 18 and 65 years
- Able to read and write using the English language
- Available to complete an eight-week intervention and six-month follow-up assessment
Key exclusion criteria (3 listed)
- Currently undergoing formal psychotherapy
- Changes in psychopharmacology type or dosage one-month prior to intervention
- Currently practicing mindfulness or meditation
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 |
|---|---|---|
| Meditation Awareness Training8 Week Meditation Intervention | Behavioural | Meditation Awareness Training |
| Cognitive Behavioral Therapy for Groups8 week intervention based on Cognitive Behavioral Theory | Behavioural | Cognitive Behavioural Therapy for Groups |
Primary outcome
Revised Fibromyalgia Impact Questionnaire
Time frame: 8 weeks
Scale Reference: Bennett, Friend, Jones, Ward, Han \& Ross (2009)
Short Form McGill Pain Questionnaire
Time frame: 8 weeks
Scale Reference: Melzack (1987)
Pittsburgh Sleep Quality Index
Time frame: 8 weeks
Scale Reference: Buysse, Reynolds Monk, Berman, \& Kupfer (1989)
Depression Anxiety and Stress Scale
Time frame: 8 weeks
Scale Reference: Lovibond \& Lovibond (1995)
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 Jun 2016.
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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.
William Van Gordon principal investigator
Nottingham Trent University
Questions about this trial
What is this clinical trial studying?
A study testing Meditation Awareness Training and Cognitive Behavioral Therapy for Groups in people with Fibromyalgia Syndrome, run by Nottingham Trent 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 4 inclusion and 3 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 Jun 2016. 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.
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?
Revised Fibromyalgia Impact Questionnaire (time frame: 8 weeks). The study lists 4 primary outcomes in all. 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 Jun 2016.