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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
Nottingham Trent University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia Syndrome focused on measuring Fibromyalgia Syndromey

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 6, 2016
    Last Updated
    June 9, 2016
    Sponsor
    Nottingham Trent University
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    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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