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Online Mindfulness Training Versus Health Education for Fibromyalgia (EGIFT)

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Emotion Regulation
Health Education
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Mindfulness, On-line intervention, Chronic pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mindfulness Emotion Regulation

Placebo

Arm Description

12 on-line modules targeting social and emotional regulation through mindfulness training

12 on-line modules providing information regarding health behaviors

Outcomes

Primary Outcome Measures

Daily Positive affect (10 items rated 1-5, averaged) and negative affect (10 items rated 1-5, averaged)
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)
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
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)

Full Information

First Posted
December 7, 2012
Last Updated
February 19, 2016
Sponsor
Arizona State University
Collaborators
Arizona Institute for Mental Health Research, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01748786
Brief Title
Online Mindfulness Training Versus Health Education for Fibromyalgia
Acronym
EGIFT
Official Title
Emotional Resilience in Fibromyalgia: A Pilot Study of Web-based Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University
Collaborators
Arizona Institute for Mental Health Research, Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Mindfulness, On-line intervention, Chronic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Emotion Regulation
Arm Type
Experimental
Arm Description
12 on-line modules targeting social and emotional regulation through mindfulness training
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
12 on-line modules providing information regarding health behaviors
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Emotion Regulation
Intervention Description
12 on-line modules provide didactic information and practice instructions re: mindfulness meditation for pain and distress
Intervention Type
Other
Intervention Name(s)
Health Education
Intervention Description
12 on-line modules that provide information regarding health behaviors, but no information regarding how to put behaviors into practice
Primary Outcome Measure Information:
Title
Daily Positive affect (10 items rated 1-5, averaged) and negative affect (10 items rated 1-5, averaged)
Description
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).
Time Frame
Daily during 6-week intervention
Title
Daily Pain Coping Efficacy (1 item rated 1-5) and Stress Coping Efficacy (2 item rated 1-5, averaged)
Description
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.
Time Frame
Daily over 6-week intervention
Secondary Outcome Measure Information:
Title
Daily Enjoyment (1 item rated 1-5) and Stressfulness (1 item rated 1-5) of Family Relations
Description
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)
Time Frame
Daily during 6-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Arizona State University
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85287-1104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23670111
Citation
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.
Results Reference
derived

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Online Mindfulness Training Versus Health Education for Fibromyalgia

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