Fibromyalgia: Interventions for Pain and Mood Regulation

Arizona State University (ASU) logo

Arizona State University (ASU)

Status

Completed

Conditions

Fibromyalgia

Treatments

Behavioral: Cognitive-behavioral
Behavioral: Mindfulness-acceptance
Other: Pain Education

Study type

Interventional

Funder types

Other

Identifiers

NCT02683278
R01AR053245

Details and patient eligibility

About

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).

Full description

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.

Enrollment

170 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

170 participants in 3 patient groups

Cognitive-Behavioral Therapy
Experimental group
Description:
Group-based cognitive-behavioral manualized treatment
Treatment:
Behavioral: Cognitive-behavioral
Mindfulness-acceptance Therapy
Experimental group
Description:
Group-based mindfulness-acceptance manualized treatment
Treatment:
Behavioral: Mindfulness-acceptance
Education
Active Comparator group
Description:
Group-based manualized pain education
Treatment:
Other: Pain Education

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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