NCT02800720

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
Last Updated

June 15, 2016

Status Verified

June 1, 2016

Enrollment Period

1.8 years

First QC Date

June 6, 2016

Last Update Submit

June 9, 2016

Conditions

Fibromyalgia Syndrome

Keywords

Fibromyalgia Syndromey

Outcome Measures

Primary Outcomes (4)

  • Revised Fibromyalgia Impact Questionnaire

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

    8 weeks

  • Short Form McGill Pain Questionnaire

    Scale Reference: Melzack (1987)

    8 weeks

  • Pittsburgh Sleep Quality Index

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

    8 weeks

  • Depression Anxiety and Stress Scale

    Scale Reference: Lovibond \& Lovibond (1995)

    8 weeks

Study Arms (2)

Meditation Awareness Training

EXPERIMENTAL

Target Intervention Arm: 8-week meditation intervention

Behavioral: Meditation Awareness Training

Cognitive Behavioural Therapy for Groups

ACTIVE COMPARATOR

Active Comparator Arm: 8-week CBT-based intervention

Behavioral: Cognitive Behavioral Therapy for Groups

Interventions

Meditation Awareness TrainingBEHAVIORAL

8 Week Meditation Intervention

Meditation Awareness Training
Cognitive Behavioral Therapy for GroupsBEHAVIORAL

8 week intervention based on Cognitive Behavioral Theory

Cognitive Behavioural Therapy for Groups

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Currently undergoing formal psychotherapy
  • Changes in psychopharmacology type or dosage one-month prior to intervention
  • Currently practicing mindfulness or meditation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fibromyalgia

Interventions

Cognitive Behavioral TherapyPopulation Groups

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesDemographyPopulation Characteristics

Study Officials

  • William Van Gordon

    Nottingham Trent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 6, 2016

First Posted

June 15, 2016

Study Start

November 1, 2012

Primary Completion

September 1, 2014

Last Updated

June 15, 2016

Record last verified: 2016-06