Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome
Primary Purpose
Fibromyalgia Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Meditation Awareness Training
Cognitive Behavioral Therapy for Groups
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia Syndrome focused on measuring Fibromyalgia Syndromey
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Currently undergoing formal psychotherapy
- Changes in psychopharmacology type or dosage one-month prior to intervention
- Currently practicing mindfulness or meditation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Meditation Awareness Training
Cognitive Behavioural Therapy for Groups
Arm Description
Target Intervention Arm: 8-week meditation intervention
Active Comparator Arm: 8-week CBT-based intervention
Outcomes
Primary Outcome Measures
Revised Fibromyalgia Impact Questionnaire
Scale Reference: Bennett, Friend, Jones, Ward, Han & Ross (2009)
Short Form McGill Pain Questionnaire
Scale Reference: Melzack (1987)
Pittsburgh Sleep Quality Index
Scale Reference: Buysse, Reynolds Monk, Berman, & Kupfer (1989)
Depression Anxiety and Stress Scale
Scale Reference: Lovibond & Lovibond (1995)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02800720
Brief Title
Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome
Official Title
Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nottingham Trent University
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia Syndrome
Keywords
Fibromyalgia Syndromey
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meditation Awareness Training
Arm Type
Experimental
Arm Description
Target Intervention Arm:
8-week meditation intervention
Arm Title
Cognitive Behavioural Therapy for Groups
Arm Type
Active Comparator
Arm Description
Active Comparator Arm:
8-week CBT-based intervention
Intervention Type
Behavioral
Intervention Name(s)
Meditation Awareness Training
Intervention Description
8 Week Meditation Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Groups
Intervention Description
8 week intervention based on Cognitive Behavioral Theory
Primary Outcome Measure Information:
Title
Revised Fibromyalgia Impact Questionnaire
Description
Scale Reference: Bennett, Friend, Jones, Ward, Han & Ross (2009)
Time Frame
8 weeks
Title
Short Form McGill Pain Questionnaire
Description
Scale Reference: Melzack (1987)
Time Frame
8 weeks
Title
Pittsburgh Sleep Quality Index
Description
Scale Reference: Buysse, Reynolds Monk, Berman, & Kupfer (1989)
Time Frame
8 weeks
Title
Depression Anxiety and Stress Scale
Description
Scale Reference: Lovibond & Lovibond (1995)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Currently undergoing formal psychotherapy
Changes in psychopharmacology type or dosage one-month prior to intervention
Currently practicing mindfulness or meditation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Van Gordon
Organizational Affiliation
Nottingham Trent University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Available IPD and Supporting Information:
Available IPD/Information Type
Embedded Qualitative Study
Available IPD/Information URL
http://link.springer.com/article/10.1007/s12671-015-0458-8
Learn more about this trial
Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome
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