Fibromyalgia: Interventions for Pain and Mood Regulation

NCT ID: NCT02683278

Last Updated: 2016-02-17

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

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2014-10-31

Brief Summary

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This study compares the impact of cognitive-behavioral therapy for pain (CBT-P), mindful awareness and acceptance treatment (M), and arthritis education as an active control condition (E) on mental and physical health outcomes among adults with chronic pain due to fibromyalgia (FM).

Detailed Description

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Both cognitive-behavioral and mindful-acceptance based treatments impact pain and disability in people with chronic pain conditions like fibromyalgia. However, these treatments target different mechanisms. The focus of CBT is on helping individuals manage their thoughts and behaviors related to pain. In contrast, the focus of M is on improving individuals' ability be aware of and accept their experiences, and to develop their positive emotional resources.

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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Cognitive-Behavioral Therapy

Group-based cognitive-behavioral manualized treatment

Group Type EXPERIMENTAL

Cognitive-behavioral

Intervention Type BEHAVIORAL

Seven sessions of group-based treatment targeting skills to improve dysfunctional pain-related thoughts and behaviors

Mindfulness-acceptance Therapy

Group-based mindfulness-acceptance manualized treatment

Group Type EXPERIMENTAL

Mindfulness-acceptance

Intervention Type BEHAVIORAL

Seven sessions of group-based treatment targeting skills to improve mindful awareness and acceptance of pain and stress, and increase positive emotional experiences

Education

Group-based manualized pain education

Group Type ACTIVE_COMPARATOR

Pain Education

Intervention Type OTHER

Seven sessions of group-based education to provide information regarding managing a chronic pain condition, but with no exercises to promote skill development

Interventions

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Cognitive-behavioral

Seven sessions of group-based treatment targeting skills to improve dysfunctional pain-related thoughts and behaviors

Intervention Type BEHAVIORAL

Mindfulness-acceptance

Seven sessions of group-based treatment targeting skills to improve mindful awareness and acceptance of pain and stress, and increase positive emotional experiences

Intervention Type BEHAVIORAL

Pain Education

Seven sessions of group-based education to provide information regarding managing a chronic pain condition, but with no exercises to promote skill development

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pain in at least 11 of 18 tenderpoints
* Able to participate in study assessments and group-based meetings
* Willing to be randomized to treatment condition

Exclusion Criteria

* Unable to understand written and spoken English
* Involved in pain-related litigation
* Currently involved in psychological treatment for pain and/or mood symptoms
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Mary Davis

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Davis, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Other Identifiers

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R01AR053245

Identifier Type: NIH

Identifier Source: org_study_id

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