NCT00167271

Brief Summary

Body worn sensors and the Internet can be used to self-monitor daily behavior and promote a healthier lifestyle in women with fibromyalgia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

October 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

February 21, 2011

Status Verified

February 1, 2011

Enrollment Period

4.1 years

First QC Date

September 9, 2005

Last Update Submit

February 18, 2011

Conditions

Fibromyalgia

Keywords

Cognitive therapy

Outcome Measures

Primary Outcomes (1)

  • Fibromyalgia Impact Questionnaire, symptom reduction

    Queries about symptoms

    6 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Computerized cognitive, behavioral therapy with Body Media armband to collect data about activity, which subjects could review each evening.

Behavioral: Cognitive Behavior Therapy

Control

ACTIVE COMPARATOR

Subjects given pamphlets from the Arthritis Foundation

Behavioral: Cognitive Behavior Therapy

Interventions

Cognitive Behavior TherapyBEHAVIORAL

Experimental: Computerized cognitive, behavioral therapy with Body Media armband to collect data about activity, which subjects could review each evening.

Also known as: Control
ControlExperimental

Eligibility Criteria

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

You may qualify if:

  • be at least 18 years of age
  • meet the American College of Rheumatology criteria for fibromyalgia
  • diagnosed with fibromyalgia at least 1 year prior to admission to the study
  • have sufficient vision to operate a computer
  • be English speaking
  • have a private telephone line

You may not qualify if:

  • live beyond a 40 mile radius of Pittsburgh

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Subjects' homes

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Joan C. Rogers, Ph.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

October 1, 2002

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

February 21, 2011

Record last verified: 2011-02

Locations

US(1)