NCT02683278

Brief Summary

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 17, 2016

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

5.9 years

First QC Date

February 7, 2016

Last Update Submit

February 16, 2016

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (5)

  • Physical Functioning

    Assessed via the SF-36 physical functioning subscale (Reference: Ware JE, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36: I. conceptual framework and item selection. Med Care 1992; 30(6):473-83.

    Change from baseline, 6-mo followup, and 12-mo followup

  • Bodily Pain

    Assessed via the SF-36 Bodily Pain subscale (Reference: Ware JE, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36): I. conceptual framework and item selection. Med Care 1992; 30(6):473-83.

    Change from baseline, 6-mo followup, and 12-mo followup

  • Vitality

    Assessed via the SF-36 Vitality subscale (Reference: Ware JE, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36): I. conceptual framework and item selection. Med Care 1992; 30(6):473-83.

    Change from baseline, 6-mo followup, and 12-mo followup

  • Depressive symptoms

    Assessed via the Hamilton Depression Inventory (Reference: Reynolds WM, Kobak KA. Reliability and validity of the Hamilton Depression Inventory: A paper-and-pencil version of the Hamilton Depression Rating Scale Clinical Interview. Psychological Assessment 1995; 7(4): 472-83.

    Change from baseline, 6-mo followup, 12-mo followup

  • Social Functioning

    Assessed via the SF-36 Social Functioning subscale (Reference: Ware JE, Sherbourne CD. The MOS 36-Item Short-Form Health Survey (SF-36): I. conceptual framework and item selection. Med Care 1992; 30(6):473-83.

    Change from baseline, 6-mo followup, and 12-mo followup

Study Arms (3)

Cognitive-Behavioral Therapy

EXPERIMENTAL

Group-based cognitive-behavioral manualized treatment

Behavioral: Cognitive-behavioral

Mindfulness-acceptance Therapy

EXPERIMENTAL

Group-based mindfulness-acceptance manualized treatment

Behavioral: Mindfulness-acceptance

Education

ACTIVE COMPARATOR

Group-based manualized pain education

Other: Pain Education

Interventions

Cognitive-behavioralBEHAVIORAL

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

Cognitive-Behavioral Therapy
Mindfulness-acceptanceBEHAVIORAL

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

Mindfulness-acceptance Therapy
Pain EducationOTHER

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

Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Mary Davis, Ph.D.

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 7, 2016

First Posted

February 17, 2016

Study Start

November 1, 2008

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

February 17, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share