Cognitive Behavioral Therapy Trial in Fibromyalgia

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.

Conditions

• Fibromyalgia

Interventions

BEHAVIORAL

Cognitive behavioral therapy

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

OTHER

Waiting list

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

Sponsors & Collaborators

• Uppsala County Council, Sweden

  collaborator OTHER_GOV

• National Social Insurance Board, Sweden

  collaborator UNKNOWN

• The Swedish Society of Medicine

  collaborator OTHER

• Reumatikerförbundet

  collaborator UNKNOWN

• Uppsala University

  lead OTHER

Principal Investigators

• Bo Karlsson, MD · Uppsala University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-01-31

Primary Completion

2003-12-31

Completion

2008-12-31

Countries

• Sweden

Study Locations