Skip to content

Online Mindfulness Training Versus Health Education for Fibromyalgia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01748786
Acronym
EGIFT
Enrollment
94
Registered
2012-12-13
Start date
2011-01-31
Completion date
2012-07-31
Last updated
2016-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Fibromyalgia, Mindfulness, On-line intervention, Chronic pain

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.

Interventions

BEHAVIORALMindfulness Emotion Regulation

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

OTHERHealth Education

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

Sponsors

Arizona Institute for Mental Health Research
CollaboratorUNKNOWN
Pfizer
CollaboratorINDUSTRY
Arizona State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Daily Positive affect (10 items rated 1-5, averaged) and negative affect (10 items rated 1-5, averaged)Daily during 6-week interventionTrajectory 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)Daily over 6-week interventionTrajectory 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

MeasureTime frameDescription
Daily Enjoyment (1 item rated 1-5) and Stressfulness (1 item rated 1-5) of Family RelationsDaily during 6-week interventionTrajectory 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026