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

NCT01611831 | Unknown

• 1 other identifier: PI11/024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

fibromyalgia; Acceptation & Commitment Therapy; randomized controlled trial

Outcome Measures

Primary Outcomes (4)

• GLOBAL FUNCTION

  GLOBAL FUNCTION is assessed with the Fibromyalgia Impact Questionnaire (FIQ), a 10-item self report questionnaire to evaluate health status of patients with fibromyalgia. The Spanish version will be used.

  At baseline

• GLOBAL FUNCTION

  GLOBAL FUNCTION is assessed with the Fibromyalgia Impact Questionnaire (FIQ), a 10-item self report questionnaire to evaluate health status of patients with fibromyalgia. The Spanish version will be used.

  At month 3

• GLOBAL FUNCTION

  GLOBAL FUNCTION is assessed with the Fibromyalgia Impact Questionnaire (FIQ), a 10-item self report questionnaire to evaluate health status of patients with fibromyalgia. The Spanish version will be used.

  At month 6

• GLOBAL FUNCTION

  GLOBAL FUNCTION is assessed with the Fibromyalgia Impact Questionnaire (FIQ), a 10-item self report questionnaire to evaluate health status of patients with fibromyalgia. The Spanish version will be used.

  At month 9

Secondary Outcomes (21)

• DEMOGRAPHIC AND CLINICAL DATA

  At Baseline

• PAIN CATASTROPHIZING

  At Baseline

• ANXIETY AND DEPRESSION

  At Baseline

• PSYCHIATRIC DIAGNOSIS

  At baseline

• PAIN

  At baseline

Study Arms (2)

ACT in group

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).

Behavioral: ACT in group

Improved Treatment as usual by General practitioner

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.

Behavioral: Improved treatment as usual by General Practitioners

Interventions

ACT in group BEHAVIORAL

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.

Also known as: Acceptation Committment Therapy in group.

ACT in group

Improved treatment as usual by General Practitioners BEHAVIORAL

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.

Also known as: Improved Treatment as Usual

Improved Treatment as usual by General practitioner

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-65 year old
• Discontinuation drug treatment 7 days before the start of the trial
• Not having received psychological treatment previously or at least in the last 2 years
• Ability to understand Spanish
• Given consent to participate in the study

You may not qualify if:

• Age: \<18 year old and \> 65 year old
• 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)

Sponsors & Collaborators

• Dr. Marta Alda: lead
• Instituto Aragones de Ciencias de la Salud: collaborator
• Carlos III Health Institute: collaborator

Study Sites (1)

Mental Health Unit, Primary Care Center "Torrero-La Paz"

Zaragoza, Zaragoza, 50009, Spain

Location

Related Publications (12)

• 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.

  PMID: 2306288 BACKGROUND

• Garcia-Campayo J, Sanz-Carrillo C, Baringo T, Ceballos C. SPECT scan in somatization disorder patients: an exploratory study of eleven cases. Aust N Z J Psychiatry. 2001 Jun;35(3):359-63. doi: 10.1046/j.1440-1614.2001.00909.x.

  PMID: 11437810 BACKGROUND

• Cook DB, Lange G, Ciccone DS, Liu WC, Steffener J, Natelson BH. Functional imaging of pain in patients with primary fibromyalgia. J Rheumatol. 2004 Feb;31(2):364-78.

  PMID: 14760810 BACKGROUND

• McCracken LM. Learning to live with the pain: acceptance of pain predicts adjustment in persons with chronic pain. Pain. 1998 Jan;74(1):21-27. doi: 10.1016/S0304-3959(97)00146-2.

  PMID: 9514556 BACKGROUND

• McCracken LM, Vowles KE, Eccleston C. Acceptance of chronic pain: component analysis and a revised assessment method. Pain. 2004 Jan;107(1-2):159-66. doi: 10.1016/j.pain.2003.10.012.

  PMID: 14715402 BACKGROUND

• Leuchter AF, Cook IA, Lufkin RB, Dunkin J, Newton TF, Cummings JL, Mackey JK, Walter DO. Cordance: a new method for assessment of cerebral perfusion and metabolism using quantitative electroencephalography. Neuroimage. 1994 Jun;1(3):208-19. doi: 10.1006/nimg.1994.1006.

  PMID: 9343572 BACKGROUND

• Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.

  PMID: 16300724 BACKGROUND

• Garcia-Campayo J, Pascual A, Alda M, Marzo J, Magallon R, Fortes S. The Spanish version of the FibroFatigue Scale: validation of a questionnaire for the observer's assessment of fibromyalgia and chronic fatigue syndrome. Gen Hosp Psychiatry. 2006 Mar-Apr;28(2):154-60. doi: 10.1016/j.genhosppsych.2005.12.001.

  PMID: 16516066 BACKGROUND

• Garcia-Campayo J, Pascual A, Alda M, Ramirez MTG. Coping with fibromialgia: usefulness of the Chronic Pain Coping Inventory-42. Pain. 2007 Nov;132 Suppl 1:S68-S76. doi: 10.1016/j.pain.2007.02.013. Epub 2007 Apr 2.

  PMID: 17400387 BACKGROUND

• Garcia Campayo J, Rodero B, Alda M, Sobradiel N, Montero J, Moreno S. [Validation of the Spanish version of the Pain Catastrophizing Scale in fibromyalgia]. Med Clin (Barc). 2008 Oct 18;131(13):487-92. doi: 10.1157/13127277. Spanish.

  PMID: 19007576 BACKGROUND

• Garcia-Campayo J, Serrano-Blanco A, Rodero B, Magallon R, Alda M, Andres E, Luciano JV, del Hoyo YL. Effectiveness of the psychological and pharmacological treatment of catastrophization in patients with fibromyalgia: a randomized controlled trial. Trials. 2009 Apr 23;10:24. doi: 10.1186/1745-6215-10-24.

  PMID: 19389246 BACKGROUND

• Garcia-Campayo J, Magdalena J, Magallon R, Fernandez-Garcia E, Salas M, Andres E. A meta-analysis of the efficacy of fibromyalgia treatment according to level of care. Arthritis Res Ther. 2008;10(4):R81. doi: 10.1186/ar2455. Epub 2008 Jul 15.

  PMID: 18627602 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Marta Alda

  Hospital Miguel Servet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: June 5, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: January 1, 2013
• Last Updated: June 5, 2012

Record last verified: 2012-05

Locations

ES (1)