Efficacy of Acceptance and Commitment Therapy (ACT) in Group in Fibromyalgia

Summary

The main objective is to assess the efficacy of Acceptance \& Commitment Therapy (ACT) in group for the treatment of fibromyalgia. The secondary aims are: 1.- To assess the cost-effectiveness of ACT and 2.- To assess the efficacy of ACT in other variables such as anxiety, depression, pain or global function. 3.- To evaluate the usefulness or electroencephalographic cordance as a prognostic variable of the treatment.

HYPOTHESIS: ACT in group is effective for improvement of pain acceptance and other outcome variables (pain, anxiety, depression, global function) in fibromyalgia, and it is cost-effective. Cordance is an useful predictor of treatment efficacy in these patients.

DESIGN: Multicentre, randomized, controlled study, with parallel groups, and a 6-month follow-up period. Participants will be randomly allocated to one of two conditions: 1.- Group Acceptation \& Commitment Therapy or 2.- Treatment as usual by his general practitioner. Patients diagnosed of fibromyalgia, according to the American College of Rheumatology, will be recruited in primary care. Assuming an alpha=0.05 and p=80%, using two tails, and calculating 5% of refusals, it will be necessary a sample size of 55 patients for each group of patients.

Conditions

• Fibromyalgia

Interventions

BEHAVIORAL

ACT in group

A protocol based on the main research studies describing the therapy and adapted for fibromyalgia treatment by our research group will be used. This protocol is available for the investigators. There will be 9 group sessions of 90 minutes duration each. Patients assigned to this arm will be allowed to occasionally take minor analgesics.

BEHAVIORAL

Improved treatment as usual by General Practitioners

General practitioners (GPs) will administer treatment as usual to the patients with fibromyalgia. To enhance the intervention, the Clinical Guidelines on the Treatment of Fibromyalgia approved by the Health Services of Aragon will be provided to the GPs.

Sponsors & Collaborators

• Instituto Aragones de Ciencias de la Salud

  collaborator OTHER_GOV

• Carlos III Health Institute

  collaborator OTHER_GOV

• Dr. Marta Alda

  lead OTHER

Principal Investigators

• Marta Alda · Hospital Miguel Servet

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2012-07-31

Completion

2013-01-31

Countries

• Spain

Study Locations