Online Mindfulness Training Versus Health Education for Fibromyalgia

NCT01748786 | Completed

• 1 other identifier: AZIMHR-01
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Mindfulness; On-line intervention; Chronic pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Daily Enjoyment (1 item rated 1-5) and Stressfulness (1 item rated 1-5) of Family Relations

  Daily during 6-week intervention

Study Arms (2)

Mindfulness Emotion Regulation

EXPERIMENTAL

12 on-line modules targeting social and emotional regulation through mindfulness training

Behavioral: Mindfulness Emotion Regulation

Placebo

PLACEBO COMPARATOR

12 on-line modules providing information regarding health behaviors

Other: Health Education

Interventions

Mindfulness Emotion Regulation BEHAVIORAL

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

Mindfulness Emotion Regulation

Health Education OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Self-report of physician diagnosis of fibromyalgia
• Able to read and understand English
• Daily access to the internet

You may not qualify if:

• Self-report of more than 5 past episodes of depression

Sponsors & Collaborators

• Arizona State University: lead
• Arizona Institute for Mental Health Research: collaborator
• Pfizer: collaborator

Study Sites (1)

Arizona State University

Tempe, Arizona, 85287-1104, United States

Location

Related Publications (1)

• Davis MC, Zautra AJ. An online mindfulness intervention targeting socioemotional regulation in fibromyalgia: results of a randomized controlled trial. Ann Behav Med. 2013 Dec;46(3):273-84. doi: 10.1007/s12160-013-9513-7.

  PMID: 23670111 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 13, 2012
• Study Start: January 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

US (1)