Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome

Fibromyalgia Syndrome Clinical Trial

Official title:

Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome: A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02800720
• Other study ID #: NTU-MATFMS
• Status: Completed
• Phase: N/A
• First received: June 6, 2016
• Last updated: June 9, 2016
• Start date: November 2012

Study information

• Verified date: June 2016
• Source: Nottingham Trent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Nottingham Trent University College of Business Law and Social Sciences Research Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes
• Syndrome

Intervention

Behavioral:
• Meditation Awareness Training
8 Week Meditation Intervention
• Cognitive Behavioral Therapy for Groups
8 week intervention based on Cognitive Behavioral Theory

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham Trent University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revised Fibromyalgia Impact Questionnaire	Scale Reference: Bennett, Friend, Jones, Ward, Han & Ross (2009)	8 weeks	No
Primary	Short Form McGill Pain Questionnaire	Scale Reference: Melzack (1987)	8 weeks	No
Primary	Pittsburgh Sleep Quality Index	Scale Reference: Buysse, Reynolds Monk, Berman, & Kupfer (1989)	8 weeks	No
Primary	Depression Anxiety and Stress Scale	Scale Reference: Lovibond & Lovibond (1995)	8 weeks	No