Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome

• Sponsor: Nottingham Trent University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02800720
• Collaborator: (none)
• Enrollment: 148
• Arms: 2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Syndrome	Behavioral: Meditation Awareness Training; Behavioral: Cognitive Behavioral Therapy for Groups	N/A

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

• Study Type: Interventional
• Actual Enrollment: 148 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome: A Randomised Controlled Trial
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Sep 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Revised Fibromyalgia Impact Questionnaire [8 weeks]

   Scale Reference: Bennett, Friend, Jones, Ward, Han & Ross (2009)

2. Short Form McGill Pain Questionnaire [8 weeks]

   Scale Reference: Melzack (1987)

3. Pittsburgh Sleep Quality Index [8 weeks]

   Scale Reference: Buysse, Reynolds Monk, Berman, & Kupfer (1989)

4. Depression Anxiety and Stress Scale [8 weeks]

   Scale Reference: Lovibond & Lovibond (1995)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Nottingham Trent University

Investigators

• Principal Investigator: William Van Gordon, Nottingham Trent University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: William Van Gordon, Principal Investigator, Nottingham Trent University
• ClinicalTrials.gov Identifier: NCT02800720
• Other Study ID Numbers: NTU-MATFMS
• First Posted: Jun 15, 2016
• Last Update Posted: Jun 15, 2016
• Last Verified: Jun 1, 2016

• Keywords provided by William Van Gordon, Principal Investigator, Nottingham Trent University: Fibromyalgia Syndromey
• Additional relevant MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome

Study Results

No Results Posted as of Jun 15, 2016