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Completed

NCT Number: NCT01748786

Online Mindfulness Training Versus Health Education for Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Chronic Pain Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Tempe, Arizona, 85287-1104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness Emotion Regulation

Behavioral

12 on-line modules provide didactic information and practice instructions re: mindfulness meditation for pain and distress

Health education

Other

12 on-line modules that provide information regarding health behaviors, but no information regarding how to put behaviors into practice

Primary outcomes

  1. 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).

  2. 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 outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • Arizona Institute for Mental Health Research
  • Pfizer

Registry information

Official study title

Emotional Resilience in Fibromyalgia: A Pilot Study of Web-based Treatment

Acronym: EGIFT

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 13, 2012
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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