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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

December 7, 2012
December 11, 2012
January 2011
July 2012   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01748786 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
Online Mindfulness Training Versus Health Education for Fibromyalgia
Emotional Resilience in Fibromyalgia: A Pilot Study of Web-based Treatment

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fibromyalgia
Behavioral: Mindfulness meditation
  • Experimental: Mindfulness Emotion Regulation
    12 module on-line training for emotion regulation via mindfulness meditation
    Intervention: Behavioral: Mindfulness meditation
  • Placebo Comparator: Health Education
    12 module on-line information about lifestyle health behaviors
Davis MC, Zautra AJ. An online mindfulness intervention targeting socioemotional regulation in fibromyalgia: results of a randomized controlled trial. Ann Behav Med. 2013 Dec;46(3):273-84. doi: 10.1007/s12160-013-9513-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01748786
AZIMHR-01
No
Arizona State University
Arizona State University
  • Arizona Institute for Mental Health Research
  • Pfizer
Not Provided
Arizona State University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP