Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome

NCT ID: NCT02800720

Last Updated: 2016-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30

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.

Conditions

Fibromyalgia Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Meditation Awareness Training

Target Intervention Arm:

8-week meditation intervention

Group Type: EXPERIMENTAL

Meditation Awareness Training

Intervention Type: BEHAVIORAL

8 Week Meditation Intervention

Cognitive Behavioural Therapy for Groups

Active Comparator Arm:

8-week CBT-based intervention

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy for Groups

Intervention Type: BEHAVIORAL

8 week intervention based on Cognitive Behavioral Theory

Interventions

Meditation Awareness Training

8 Week Meditation Intervention

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy for Groups

8 week intervention based on Cognitive Behavioral Theory

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nottingham Trent University

OTHER

Sponsor Role: lead

Responsible Party

William Van Gordon

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William Van Gordon

Role: PRINCIPAL_INVESTIGATOR

Nottingham Trent University

Study Documents

Document Type: Embedded Qualitative Study

View Document

Other Identifiers

NTU-MATFMS

Identifier Type: -

Identifier Source: org_study_id