Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome

June 9, 2016 updated by: William Van Gordon, Nottingham Trent University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Meditation Awareness Training

Target Intervention Arm:

8-week meditation intervention
Behavioral: Meditation Awareness Training
8 Week Meditation Intervention
Active Comparator: Cognitive Behavioural Therapy for Groups

Active Comparator Arm:

8-week CBT-based intervention
Behavioral: Cognitive Behavioral Therapy for Groups
8 week intervention based on Cognitive Behavioral Theory

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Revised Fibromyalgia Impact Questionnaire
Time Frame: 8 weeks
Scale Reference: Bennett, Friend, Jones, Ward, Han & Ross (2009)
8 weeks
Short Form McGill Pain Questionnaire
Time Frame: 8 weeks
Scale Reference: Melzack (1987)
8 weeks
Pittsburgh Sleep Quality Index
Time Frame: 8 weeks
Scale Reference: Buysse, Reynolds Monk, Berman, & Kupfer (1989)
8 weeks
Depression Anxiety and Stress Scale
Time Frame: 8 weeks
Scale Reference: Lovibond & Lovibond (1995)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham Trent University

Investigators

  • Principal Investigator: William Van Gordon, Nottingham Trent University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

June 9, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Estimate)

June 15, 2016

Last Update Submitted That Met QC Criteria

June 9, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTU-MATFMS

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Embedded Qualitative Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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