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Completed

NCT Number: NCT02800720

Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meditation Awareness Training

Behavioral

8 Week Meditation Intervention

Cognitive Behavioral Therapy for Groups

Behavioral

8 week intervention based on Cognitive Behavioral Theory

Primary outcomes

  1. Revised Fibromyalgia Impact Questionnaire

    Time frame: 8 weeks

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

  2. Short Form McGill Pain Questionnaire

    Time frame: 8 weeks

    Scale Reference: Melzack (1987)

  3. Pittsburgh Sleep Quality Index

    Time frame: 8 weeks

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

  4. Depression Anxiety and Stress Scale

    Time frame: 8 weeks

    Scale Reference: Lovibond & Lovibond (1995)

Sponsors and collaborators

Lead sponsor

Nottingham Trent University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
First posted
Jun 15, 2016
Registry last updated
Jun 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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