Online Mindfulness Training Versus Health Education for Fibromyalgia

Study Overview
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Brief Summary
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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.

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: Mindfulness Emotion Regulation
* Other: Health Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Emotion Regulation<br>12 on-line modules targeting social and emotional regulation through mindfulness training | Behavioral: Mindfulness Emotion Regulation<br>* 12 on-line modules provide didactic information and practice instructions re: mindfulness meditation for pain and distress<br>|
| Placebo Comparator: Placebo<br>12 on-line modules providing information regarding health behaviors | Other: Health Education<br>* 12 on-line modules that provide information regarding health behaviors, but no information regarding how to put behaviors into practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Mindfulness, On-line intervention, Chronic pain