Online Mindfulness Training Versus Health Education for Fibromyalgia

Fibromyalgia Clinical Trial

— EGIFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748786
• Other study ID #: AZIMHR-01
• Status: Completed
• Phase: N/A
• First received: December 7, 2012
• Last updated: February 19, 2016
• Start date: January 2011
• Est. completion date: July 2012

Study information

• Verified date: February 2016
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
United States	Arizona State University	Tempe	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Arizona State University	Arizona Institute for Mental Health Research, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 during 6-week intervention	No
Primary	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.	Daily over 6-week intervention	No
Secondary	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)	Daily during 6-week intervention	No