NCT01004458

Brief Summary

Previous studies have shown that the disorder fibromyalgia often is preceded by long-term stress. Moreover, an association has been shown between stress, pain and co-morbidity in these patients. Cognitive behavioral therapy (CBT) has been shown effective in reducing stress, anxiety and pain in rheumatoid arthritis and fibromyalgia. The purpose of the present trial was to assess whether CBT may reduce pain and other symptoms and increase well-being and general function, affect biological markers for pain and long-term stress, to a larger extent than treatment "as usual". Forty eight women with verified fibromyalgia were randomly allocated to an early treatment group or a waiting list group. The early treatment group received CBT group treatment during six months. Measurements of outcome and potential outcome affecting variables were made at baseline, after six months and one year after baseline. The waiting list group received the same CBT treatment as the early treatment group after six months on the waiting list. The design is thus a traditional "waiting list design", allowing a two parallel group comparison during the first six months and a "before-after" analysis in both groups when the treatment was concluded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2001

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

January 1, 2001

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2009

Completed
Last Updated

October 30, 2009

Status Verified

October 1, 2009

Enrollment Period

2.9 years

First QC Date

October 29, 2009

Last Update Submit

October 29, 2009

Conditions

Fibromyalgia

Keywords

fibromyalgiacognitive behavioral therapywomenpainstresstype A behavior

Outcome Measures

Primary Outcomes (1)

  • Multidimensional Pain Inventory (MPI) score

    At baseline and at 6 and 12 months after baseline

Secondary Outcomes (1)

  • Type A behavior measures

    At baseline and at 6 and 12 months after baseline

Study Arms (2)

Early treatment group

ACTIVE COMPARATOR

The experimental group receiving CBT

Behavioral: Cognitive behavioral therapy

Waiting list group

NO INTERVENTION

The waiting list group served as referents during the trial

Other: Waiting list

Interventions

Cognitive behavioral therapyBEHAVIORAL

The treatment, adopted to reduce hostility and stress behavior, was given during group sessions once a week during six months with two follow-up occasions during the next six months

Early treatment group
Waiting listOTHER

The group served as referents during the trial and received no intervention other than measurements at the same points in time as the intervention group

Waiting list group

Eligibility Criteria

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

You may qualify if:

  • Fibromyalgia according to the American College of Rheumatology criteria
  • Women
  • Age 18-65
  • Living in Östhammar municipality, Sweden
  • Swedish speaking

You may not qualify if:

  • severe mental disease
  • drug or alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Public Health and Caring Sciences, Family Medicin and Clinical Epidemiology Section

Uppsala, SE-75122, Sweden

Location

Related Publications (1)

  • Karlsson B, Nyberg F, Svardsudd K, Burell G, Bjorkegren K, Kristiansson P. Neuropeptide Y and measures of stress in a longitudinal study of women with the fibromyalgia syndrome. Scand J Pain. 2022 Jun 21;23(1):59-65. doi: 10.1515/sjpain-2022-0016. Print 2023 Jan 27.

    PMID: 35728621DERIVED

Related Links

MeSH Terms

Conditions

FibromyalgiaPain

Interventions

Cognitive Behavioral TherapyWaiting Lists

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesAppointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Bo Karlsson, MD

    Uppsala University

    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

October 29, 2009

First Posted

October 30, 2009

Study Start

January 1, 2001

Primary Completion

December 1, 2003

Study Completion

December 1, 2008

Last Updated

October 30, 2009

Record last verified: 2009-10

Locations

SE(1)