Online Mindfulness Training Versus Health Education for Fibromyalgia

NCT ID: NCT01748786

Last Updated: 2016-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-07-31

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.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness Emotion Regulation

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

Group Type EXPERIMENTAL

Mindfulness Emotion Regulation

Intervention Type BEHAVIORAL

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

Placebo

12 on-line modules providing information regarding health behaviors

Group Type PLACEBO_COMPARATOR

Health Education

Intervention Type OTHER

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

Interventions

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Mindfulness Emotion Regulation

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

Intervention Type BEHAVIORAL

Health Education

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arizona Institute for Mental Health Research

UNKNOWN

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona State University

Tempe, Arizona, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23670111 (View on PubMed)

Other Identifiers

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AZIMHR-01

Identifier Type: -

Identifier Source: org_study_id

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