Online Mindfulness Training Versus Health Education for Fibromyalgia (EGIFT)

This study has been completed.
Sponsor:
Collaborators:
Arizona Institute for Mental Health Research
Pfizer
Information provided by (Responsible Party):
Arizona State University
ClinicalTrials.gov Identifier:
NCT01748786
First received: December 7, 2012
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to compare an online 12-module intervention designed to improve emotion regulation and social relations via mindfulness training with a 12-module program that provides information about health behaviors to individuals with fibromyalgia. The mindfulness training program is expected to produce greater day-to-day improvements than the education condition in individuals' efficacy for coping with pain and stress, positive and negative affect, and positive engagement in social relations assessed via online diaries completed each evening during the intervention period.


Condition Intervention
Fibromyalgia
Behavioral: Mindfulness meditation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Emotional Resilience in Fibromyalgia: A Pilot Study of Web-based Treatment

Resource links provided by NLM:


Further study details as provided by Arizona State University:

Primary Outcome Measures:
  • Positive and negative affect [ Time Frame: Daily during 6-week intervention ] [ Designated as safety issue: No ]
    Trajectory of change in positive affect over the course of the trial is assessed via daily diaries. Positive and negative affect are assessed daily with the Positive (10 items) and Negative (10 items) Affect Schedule (PANAS; Watson, Clark, & Tellegen, 1988).

  • Pain and Stress Coping Efficacy [ Time Frame: Daily over 6-week intervention ] [ Designated as safety issue: No ]
    Trajectory of change over the course of the intervention via daily diary reports. Pain and stress coping efficacy (PCE and SCE) are assessed with 2 items each, with items combined to form a mean score for PCE and for SCE (Johnson, Zautra, & Davis 2006). "The first was "How satisfied are you with how you coped with your symptoms (stress)?" referring to that day, rated on a 5-point Likert scale ranging from 1=very dissatisfied to 5=very satisfied. The second item was "If you had this level of pain (stress) again, how certain are you that you would be able to cope well with its negative aspects?" rated on a 5-point Likert scale, ranging from 1=very uncertain to 5 = very certain.


Secondary Outcome Measures:
  • Enjoyment and Stressfulness of Family Relations [ Time Frame: Daily during 6-week intervention ] [ Designated as safety issue: No ]
    Trajectory of change over the course of the trial via daily diaries. Daily family relations were assessed by two items asking how enjoyable (1 item) and how stressful (1 item) individuals found the time they spent with family on that day, with each item rated on a 4-point scale ranging from 1=not at all to 4 = extremely. These items were drawn from the Inventory of Small Life Events scale (Zautra, Guarnaccia, & Dohrenwend, 1986)


Enrollment: 94
Study Start Date: January 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness Emotion Regulation
12 module on-line training for emotion regulation via mindfulness meditation
Behavioral: Mindfulness meditation
Placebo Comparator: Health Education
12 module on-line information about lifestyle health behaviors

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Self-report of physician diagnosis of fibromyalgia
  • Able to read and understand English
  • Daily access to the internet

Exclusion Criteria:

  • Self-report of more than 5 past episodes of depression
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748786

Locations
United States, Arizona
Arizona State University
Tempe, Arizona, United States, 85287-1104
Sponsors and Collaborators
Arizona State University
Arizona Institute for Mental Health Research
Pfizer
  More Information

No publications provided by Arizona State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arizona State University
ClinicalTrials.gov Identifier: NCT01748786     History of Changes
Other Study ID Numbers: AZIMHR-01
Study First Received: December 7, 2012
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Arizona State University:
Fibromyalgia
Mindfulness
On-line intervention
Chronic pain

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 01, 2014