Clinical trial NCT01611831: Efficacy of Acceptance and Commitment Therapy (ACT) in Group in Fibromyalgia
Official title: Efficacy of Acceptance and Commitment Therapy (ACT) in Group in Fibromyalgia: a Randomized, Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
Acceptation & Commitment Therapy
randomized controlled trial
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
Collaborators: name: Instituto Aragones de Ciencias de la Salud
name: Carlos III Health Institute
First posted: 2012-06-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: GLOBAL FUNCTION
timeFrame: At baseline
measure: GLOBAL FUNCTION
timeFrame: At month 3
measure: GLOBAL FUNCTION
timeFrame: At month 6
measure: GLOBAL FUNCTION
timeFrame: At month 9
Secondary outcomes:
measure: DEMOGRAPHIC AND CLINICAL DATA
timeFrame: At Baseline
measure: PAIN CATASTROPHIZING
timeFrame: At Baseline
measure: ANXIETY AND DEPRESSION
timeFrame: At Baseline
measure: PSYCHIATRIC DIAGNOSIS
timeFrame: At baseline
measure: PAIN
timeFrame: At baseline
measure: COST-EFFECTIVENESS ANALYSIS
timeFrame: At Baseline
measure: PAIN ACCEPTANCE
timeFrame: At Baseline
measure: CORDANCE
timeFrame: At baseline
measure: PAIN CATASTROPHIZING
timeFrame: At month 3
measure: PAIN CATASTROPHIZING
timeFrame: At month 6
measure: ANXIETY AND DEPRESSION
timeFrame: At month 3
measure: ANXIETY AND DEPRESSION
timeFrame: At month 6
measure: PAIN
timeFrame: At month 3
measure: PAIN
timeFrame: At month 6
measure: COST-EFFECTIVENESS ANALYSIS
timeFrame: At month 3
measure: COST-EFFECTIVENESS ANALYSIS
timeFrame: At month 6
measure: COST-EFFECTIVENESS ANALYSIS
timeFrame: At month 9
measure: PAIN ACCEPTANCE
timeFrame: At month 3
measure: PAIN ACCEPTANCE
timeFrame: At month 6
measure: PAIN ACCEPTANCE
timeFrame: At month 9
measure: CORDANCE
timeFrame: At month 3
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Mental Health Unit, Primary Care Center "Torrero-La Paz"
Study officials:
affiliation: Hospital Miguel Servet
name: Marta Alda
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
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