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Online Mindfulness Training Versus Health Education for Fibromyalgia (EGIFT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01748786
First Posted: December 13, 2012
Last Update Posted: February 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Arizona Institute for Mental Health Research
Pfizer
Information provided by (Responsible Party):
Arizona State University
  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 Emotion Regulation Other: Health Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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:
  • Daily Positive affect (10 items rated 1-5, averaged) and negative affect (10 items rated 1-5, averaged) [ Time Frame: Daily during 6-week intervention ]
    Trajectory of change in positive affect over the course of the trial is assessed via daily diaries. Positive and negative affect subscales are assessed daily with the Positive (10 items) and Negative (10 items) Affect Schedule (PANAS; Watson, Clark, & Tellegen, 1988).

  • Daily Pain Coping Efficacy (1 item rated 1-5) and Stress Coping Efficacy (2 item rated 1-5, averaged) [ Time Frame: Daily over 6-week intervention ]
    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:
  • Daily Enjoyment (1 item rated 1-5) and Stressfulness (1 item rated 1-5) of Family Relations [ Time Frame: Daily during 6-week intervention ]
    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 on-line modules targeting social and emotional regulation through mindfulness training
Behavioral: Mindfulness Emotion Regulation
12 on-line modules provide didactic information and practice instructions re: mindfulness meditation for pain and distress
Placebo Comparator: Placebo
12 on-line modules providing information regarding health behaviors
Other: Health Education
12 on-line modules that provide information regarding health behaviors, but no information regarding how to put behaviors into practice

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: December 7, 2012
First Posted: December 13, 2012
Last Update Posted: February 23, 2016
Last Verified: February 2016

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