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Online Mindfulness Training Versus Health Education for Fibromyalgia (EGIFT)

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.
 
ClinicalTrials.gov Identifier: NCT01748786
Recruitment Status : Completed
First Posted : December 13, 2012
Last Update Posted : February 23, 2016
Sponsor:
Collaborators:
Arizona Institute for Mental Health Research
Pfizer
Information provided by (Responsible Party):
Arizona State University

Tracking Information
First Submitted Date  ICMJE December 7, 2012
First Posted Date  ICMJE December 13, 2012
Last Update Posted Date February 23, 2016
Study Start Date  ICMJE January 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
  • Positive and negative affect [ 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 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 ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2016)
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)
Original Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
Enjoyment and Stressfulness 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Online Mindfulness Training Versus Health Education for Fibromyalgia
Official Title  ICMJE Emotional Resilience in Fibromyalgia: A Pilot Study of Web-based Treatment
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Behavioral: Mindfulness Emotion Regulation
    12 on-line modules provide didactic information and practice instructions re: mindfulness meditation for pain and distress
  • Other: Health Education
    12 on-line modules that provide information regarding health behaviors, but no information regarding how to put behaviors into practice
Study Arms  ICMJE
  • Experimental: Mindfulness Emotion Regulation
    12 on-line modules targeting social and emotional regulation through mindfulness training
    Intervention: Behavioral: Mindfulness Emotion Regulation
  • Placebo Comparator: Placebo
    12 on-line modules providing information regarding health behaviors
    Intervention: Other: Health Education
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2012)
94
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01748786
Other Study ID Numbers  ICMJE AZIMHR-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arizona State University
Study Sponsor  ICMJE Arizona State University
Collaborators  ICMJE
  • Arizona Institute for Mental Health Research
  • Pfizer
Investigators  ICMJE Not Provided
PRS Account Arizona State University
Verification Date February 2016

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