Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome

Not Applicable

Completed

• Conditions: Fibromyalgia Syndrome
• Interventions: Behavioral: Cognitive Behavioral Therapy for Groups; Behavioral: Meditation Awareness Training

• Registration Number: NCT02800720
• Lead Sponsor: Nottingham Trent University

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.

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2014-09
• Status Verified: 2016-06
• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-06-09
• Last Update Submitted: 2016-06-09
• Study First Posted: 2016-06-15
• Last Update Posted: 2016-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioural Therapy for Groups	Cognitive Behavioral Therapy for Groups	Active Comparator Arm: 8-week CBT-based intervention
Meditation Awareness Training	Meditation Awareness Training	Target Intervention Arm: 8-week meditation intervention

Primary Outcome Measures

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