Online Mindfulness Training Versus Health Education for Fibromyalgia (EGIFT)
This study has been completed.
Sponsor:
Arizona State University
Collaborators:
Arizona Institute for Mental Health Research
Pfizer
Information provided by (Responsible Party):
Arizona State University
ClinicalTrials.gov Identifier:
NCT01748786
First received: December 7, 2012
Last updated: December 11, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Fibromyalgia |
Behavioral: Mindfulness meditation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Emotional Resilience in Fibromyalgia: A Pilot Study of Web-based Treatment |
Resource links provided by NLM:
Further study details as provided by Arizona State University:
Primary Outcome Measures:
- Positive and negative affect [ Time Frame: Daily during 6-week intervention ] [ Designated as safety issue: No ]Trajectory of change in positive affect over the course of the trial is assessed via daily diaries. Positive and negative affect are assessed daily with the Positive (10 items) and Negative (10 items) Affect Schedule (PANAS; Watson, Clark, & Tellegen, 1988).
- Pain and Stress Coping Efficacy [ Time Frame: Daily over 6-week intervention ] [ Designated as safety issue: No ]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:
- Enjoyment and Stressfulness of Family Relations [ Time Frame: Daily during 6-week intervention ] [ Designated as safety issue: No ]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)
| Enrollment: | 94 |
| Study Start Date: | January 2011 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Mindfulness Emotion Regulation
12 module on-line training for emotion regulation via mindfulness meditation
|
Behavioral: Mindfulness meditation |
|
Placebo Comparator: Health Education
12 module on-line information about lifestyle health behaviors
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Arizona State University |
| ClinicalTrials.gov Identifier: | NCT01748786 History of Changes |
| Other Study ID Numbers: | AZIMHR-01 |
| Study First Received: | December 7, 2012 |
| Last Updated: | December 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Arizona State University:
|
Fibromyalgia Mindfulness On-line intervention Chronic pain |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013