Online Mindfulness Training Versus Health Education for Fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Behavioral: Mindfulness Emotion Regulation; Other: Health Education

• Registration Number: NCT01748786
• Lead Sponsor: Arizona State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-13
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-19
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Emotion Regulation	Mindfulness Emotion Regulation	12 on-line modules targeting social and emotional regulation through mindfulness training
Placebo	Health Education	12 on-line modules providing information regarding health behaviors

Primary Outcome Measures

Name	Time	Method
Daily Positive affect (10 items rated 1-5, averaged) and negative affect (10 items rated 1-5, averaged)	Daily during 6-week intervention	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)	Daily over 6-week intervention	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

Name	Time	Method
Daily Enjoyment (1 item rated 1-5) and Stressfulness (1 item rated 1-5) of Family Relations	Daily during 6-week intervention	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)

Trial Locations

Locations (1)

Arizona State University; 🇺🇸 Tempe, Arizona, United States