Online Mindfulness Training Versus Health Education for Fibromyalgia

NCT01748786

Last updated date
Study Location
Arizona State University
Tempe, Arizona, 85287-1104, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fibromyalgia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Self-report of more than 5 past episodes of depression

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

FibromyalgiaFibromyalgia of Less Than One Year Duration. Study of Pregabalin
NCT01397006
  1. Newton, Massachusetts
ALL GENDERS
18 Years+
years
MULTIPLE SITES
FibromyalgiaFixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
NCT01226667
  1. Beverly Hills, California
  2. Beverly Hills, California
  3. Huntington Beach, California
  4. Tucson, California
  5. West Hills, California
Female
18 Years+
years
MULTIPLE SITES
FibromyalgiaOnline Mindfulness Training Versus Health Education for Fibromyalgia
NCT01748786
  1. Tempe, Arizona
ALL GENDERS
18 Years+
years
MULTIPLE SITES
FibromyalgiaAn Open-Label Trial of Pregabalin in Patients With Fibromyalgia
NCT00151528
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Huntsville, Alabama
  4. Phoenix, Arizona
  5. Phoenix, Arizona
  6. Scottsdale, Arizona
  7. Hot Springs, Arkansas
  8. Little Rock, Arkansas
  9. Beverly Hills, California
  10. Los Alamitos, California
  11. Newport Beach, California
  12. Northridge, California
  13. Pismo Beach, California
  14. Redondo Beach, California
  15. Riverside, California
  16. Walnut Creek, California
  17. Whittier, California
  18. Danbury, Connecticut
  19. New Milford, Connecticut
  20. Stratford, Connecticut
  21. Clearwater, Florida
  22. Miami, Florida
  23. Ocala, Florida
  24. Palm Beach Gardens, Florida
  25. Seminole, Florida
  26. St. Petersburg, Florida
  27. St. Petersburg, Florida
  28. St. Petersburg, Florida
  29. Sunrise, Florida
  30. West Palm Beach, Florida
  31. Atlanta, Georgia
  32. Decatur, Georgia
  33. Boise, Idaho
  34. Chicago, Illinois
  35. Maywood, Illinois
  36. Oak Brook, Illinois
  37. Peoria, Illinois
  38. Kansas City, Kansas
  39. Overland Park, Kansas
  40. Madisonville, Kentucky
  41. New Orleans, Louisiana
  42. Newton, Massachusetts
  43. Kalamazoo, Michigan
  44. Lansing, Michigan
  45. Kansas City, Missouri
  46. Lebanon, New Hampshire
  47. Princeton, New Jersey
  48. Albany, New York
  49. New York, New York
  50. Rochester, New York
  51. Charlotte, North Carolina
  52. Wilmington, North Carolina
  53. Wilmington, North Carolina
  54. Winston Salem, North Carolina
  55. Winston-Salem, North Carolina
  56. Cincinnati, Ohio
  57. Columbus, Ohio
  58. Columbus, Ohio
  59. Mogadore, Ohio
  60. Toledo, Ohio
  61. Oklahoma City, Oklahoma
  62. Eugene, Oregon
  63. Medford, Oregon
  64. Portland, Oregon
  65. Altoona, Pennsylvania
  66. Duncansville, Pennsylvania
  67. Johnstown, Pennsylvania
  68. Mechanicsburg, Pennsylvania
  69. Philadelphia, Pennsylvania
  70. Philadelphia, Pennsylvania
  71. Pittsburgh, Pennsylvania
  72. Pittsburgh, Pennsylvania
  73. Pittsburgh, Pennsylvania
  74. Pottstown, Pennsylvania
  75. West Reading, Pennsylvania
  76. Wyomissing, Pennsylvania
  77. Anderson, South Carolina
  78. Charleston, South Carolina
  79. Greer, South Carolina
  80. Memphis, Tennessee
  81. Memphis, Tennessee
  82. Nashville, Tennessee
  83. Austin, Texas
  84. Dallas, Texas
  85. Lubbock, Texas
  86. Richardson, Texas
  87. San Antonio, Texas
  88. San Antonio, Texas
  89. Salt Lake City, Utah
  90. Woodstock, Vermont
  91. Virginia Beach, Virginia
  92. Seattle, Washington
  93. Seattle, Washington
  94. Yakima, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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