Overview

This trial is active, not recruiting.

Condition fibromyalgia
Treatments act in group, improved treatment as usual by general practitioners
Sponsor Dr. Marta Alda
Collaborator Instituto Aragones de Ciencias de la Salud
Start date January 2012
End date July 2012
Trial size 80 participants
Trial identifier NCT01611831, PI11/024

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients assigned to this arm will receive Acceptation and Commitment Therapy (ACT) in groups of 8-12 patients. Intervention has been protocolized. Therapy will be administered by two experienced therapists (psychologists).
act in group Acceptation Committment Therapy 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.
(Active Comparator)
Patients assigned to this arm will receive treatment as usual by their General Practitioner in the Primary Care center. To enhance treatment, investigators participating in the trial will receive the Guidelines for fibromyalgia treatment in Primary Care handed by Health Service in Aragón.
improved treatment as usual by general practitioners Improved Treatment as Usual
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.

Primary Outcomes

Measure
GLOBAL FUNCTION
time frame: At baseline
GLOBAL FUNCTION
time frame: At month 3
GLOBAL FUNCTION
time frame: At month 6
GLOBAL FUNCTION
time frame: At month 9

Secondary Outcomes

Measure
DEMOGRAPHIC AND CLINICAL DATA
time frame: At Baseline
PAIN CATASTROPHIZING
time frame: At Baseline
ANXIETY AND DEPRESSION
time frame: At Baseline
PSYCHIATRIC DIAGNOSIS
time frame: At baseline
PAIN
time frame: At baseline
COST-EFFECTIVENESS ANALYSIS
time frame: At Baseline
PAIN ACCEPTANCE
time frame: At Baseline
CORDANCE
time frame: At baseline
PAIN CATASTROPHIZING
time frame: At month 3
PAIN CATASTROPHIZING
time frame: At month 6
ANXIETY AND DEPRESSION
time frame: At month 3
ANXIETY AND DEPRESSION
time frame: At month 6
PAIN
time frame: At month 3
PAIN
time frame: At month 6
COST-EFFECTIVENESS ANALYSIS
time frame: At month 3
COST-EFFECTIVENESS ANALYSIS
time frame: At month 6
COST-EFFECTIVENESS ANALYSIS
time frame: At month 9
PAIN ACCEPTANCE
time frame: At month 3
PAIN ACCEPTANCE
time frame: At month 6
PAIN ACCEPTANCE
time frame: At month 9
CORDANCE
time frame: At month 3

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: 1. Age: 18-65 year old 2. Discontinuation drug treatment 7 days before the start of the trial 3. Not having received psychological treatment previously or at least in the last 2 years 4. Ability to understand Spanish 5. Given consent to participate in the study Exclusion Criteria: 1. Age: <18 year old and > 65 year old 2. Clinical or psychological disease that, at investigator's opinion, can interfere the psychological examination or the adherence to psychotherapy (dementia, alcohol or drug abuse, psychosis, severe personality disorder)

Additional Information

Official title Efficacy of Acceptance and Commitment Therapy (ACT) in Group in Fibromyalgia: a Randomized, Controlled Study.
Principal investigator Marta Alda
Description The main outcome will be pain acceptance. Other outcome measures will be global function (assessed with the Fibromyalgia Impact Questionnaire, FIQ), cost-effectiveness (evaluated by the Client Service Receipt Inventory, CSRI) and electroencephalographic cordance. The mediating variables included are anxiety and depression (assessed with the Hospital Anxiety and Depression scale, HADS) and pain (measured with an analog visual scale). A psychiatric interview will be administered to the participants to diagnose Posttraumatic Stress Disorder. Statistical analysis will be carried out for intention to treat, and using the method Last Observation Carried Forward. A Repeated Measures Mixed Model will be used to study the main outcome. All calculations will be made with two tails and a significance of 0.05.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Hospital Miguel Servet.