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

Efficacy of Acceptance and Commitment Therapy (ACT) in Group in Fibromyalgia: a Randomized, Controlled Study.

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.

Study Overview

• Status: Unknown
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: ACT in group; Behavioral: Improved treatment as usual by General Practitioners

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50009
    • Mental Health Unit, Primary Care Center "Torrero-La Paz"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACT in group; 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; 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.; Other Names: Acceptation Committment Therapy in group.
Active Comparator: Improved Treatment as usual by General practitioner; 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; 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.; Other Names: Improved Treatment as Usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
DEMOGRAPHIC AND CLINICAL DATA	It has been designed a questionnaire to collect demographic data (sex, age, marital status, education level, job, work disability) and clinical data (psychiatric medical history, disease duration, main symptoms, medical comorbidity etc)	At Baseline
PAIN CATASTROPHIZING	It is described as a negative and exaggerated reaction towards painful stimulus. It is measured with the Pain Catastrophizing Scale that allows investigators to discriminate 3 sub-scales: rumination, magnification and helplessness. The Spanish validation of this scale will be used.	At Baseline
ANXIETY AND DEPRESSION	They will be evaluated with the Hospital Anxiety and Depression Scale (HADS), a scale to detect anxiety and depression in people with medical diseases such as fibromyalgia. It is a 14-item self report scale in which items are scored in a Likert scale from 1 to 4. It includes 2 subscales: anxiety and depression, scored independently. The HADS has been validated in Spanish.	At Baseline
PSYCHIATRIC DIAGNOSIS	The Standardized Polyvalent Psychiatric Interview (SPPI) will be used. It is a psychiatric interview developed by our research group to assess psychiatric morbidity in primary care. It allows the use of different diagnosis criteria like DSM-IV and ICD-10. The Posttraumatic stress disorder will be assessed specifically as it has been shown to be related to a worse prognosis in fibromyalgia.	At baseline
PAIN	It will be assessed with The Analogue Visual Pain Scale. Pain is self-reported by the patient in a visual analogue scale from 0 (pain absence) to 100 (the worst pain anyone can ever imagine)	At baseline
COST-EFFECTIVENESS ANALYSIS	COST-EFFECTIVENESS ANALYSIS: Includes a) Drug profile, and b) Services.	At Baseline
PAIN ACCEPTANCE	Acceptance is related to a better adaptation to pain response, no matter the influence of outcomes such as depression, pain intensity or anxiety. The Chronic Pain Acceptance Questionnaire will be used. This outcome will be measured with the Spanish version validated by our research group.	At Baseline
CORDANCE	CORDANCE: the Fast Fourier Transform (FFT) will be applied to artefact-free electroencephalogram activity segments to calculate absolute and relative powers for each electrode.	At baseline
PAIN CATASTROPHIZING	It is described as a negative and exaggerated reaction towards painful stimulus. It is measured with the Pain Catastrophizing Scale that allows investigators to discriminate 3 sub-scales: rumination, magnification and helplessness. The Spanish validation of this scale will be used.	At month 3
PAIN CATASTROPHIZING	It is described as a negative and exaggerated reaction towards painful stimulus. It is measured with the Pain Catastrophizing Scale that allows investigators to discriminate 3 sub-scales: rumination, magnification and helplessness. The Spanish validation of this scale will be used.	At month 6
ANXIETY AND DEPRESSION	They will be evaluated with the Hospital Anxiety and Depression Scale (HADS), a scale to detect anxiety and depression in people with medical diseases such as fibromyalgia. It is a 14-item self report scale in which items are scored in a Likert scale from 1 to 4. It includes 2 subscales: anxiety and depression, scored independently. The HADS has been validated in Spanish.	At month 3
ANXIETY AND DEPRESSION	They will be evaluated with the Hospital Anxiety and Depression Scale (HADS), a scale to detect anxiety and depression in people with medical diseases such as fibromyalgia. It is a 14-item self report scale in which items are scored in a Likert scale from 1 to 4. It includes 2 subscales: anxiety and depression, scored independently. The HADS has been validated in Spanish.	At month 6
PAIN	It will be assessed with The Analogue Visual Pain Scale. Pain is self-reported by the patient in a visual analogue scale from 0 (pain absence) to 100 (the worst pain anyone can ever imagine)	At month 3
PAIN	It will be assessed with The Analogue Visual Pain Scale. Pain is self-reported by the patient in a visual analogue scale from 0 (pain absence) to 100 (the worst pain anyone can ever imagine)	At month 6
COST-EFFECTIVENESS ANALYSIS	COST-EFFECTIVENESS ANALYSIS: Includes a) Drug profile, and b) Services.	At month 3
COST-EFFECTIVENESS ANALYSIS	COST-EFFECTIVENESS ANALYSIS: Includes a) Drug profile, and b) Services.	At month 6
COST-EFFECTIVENESS ANALYSIS	COST-EFFECTIVENESS ANALYSIS: Includes a) Drug profile, and b) Services.	At month 9
PAIN ACCEPTANCE	Acceptance is related to a better adaptation to pain response, no matter the influence of outcomes such as depression, pain intensity or anxiety. The Chronic Pain Acceptance Questionnaire will be used. This outcome will be measured with the Spanish version validated by our research group.	At month 3
PAIN ACCEPTANCE	Acceptance is related to a better adaptation to pain response, no matter the influence of outcomes such as depression, pain intensity or anxiety. The Chronic Pain Acceptance Questionnaire will be used. This outcome will be measured with the Spanish version validated by our research group.	At month 6
PAIN ACCEPTANCE	Acceptance is related to a better adaptation to pain response, no matter the influence of outcomes such as depression, pain intensity or anxiety. The Chronic Pain Acceptance Questionnaire will be used. This outcome will be measured with the Spanish version validated by our research group.	At month 9
CORDANCE	CORDANCE: the Fast Fourier Transform (FFT) will be applied to artefact-free electroencephalogram activity segments to calculate absolute and relative powers for each electrode.	At month 3

Collaborators and Investigators

• Sponsor: Dr. Marta Alda
• Collaborators: Carlos III Health Institute; Instituto Aragones de Ciencias de la Salud
• Investigators: Principal Investigator: Marta Alda, Hospital Miguel Servet

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: May 11, 2012
• First Submitted That Met QC Criteria: June 4, 2012
• First Posted (Estimate): June 5, 2012

Study Record Updates

• Last Update Posted (Estimate): June 5, 2012
• Last Update Submitted That Met QC Criteria: June 4, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: randomized controlled trial; fibromyalgia; Acceptation & Commitment Therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: PI11/024