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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Hospital Miguel Servet.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Instituto Aragones de Ciencias de la Salud
Carlos III Health Institute
Information provided by (Responsible Party):
Dr. Marta Alda, Hospital Miguel Servet
ClinicalTrials.gov Identifier:
NCT01611831
First received: May 11, 2012
Last updated: June 4, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Fibromyalgia
Behavioral: ACT in group
Behavioral: Improved treatment as usual by General Practitioners

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Acceptance and Commitment Therapy (ACT) in Group in Fibromyalgia: a Randomized, Controlled Study.

Resource links provided by NLM:


Further study details as provided by Hospital Miguel Servet:

Primary Outcome Measures:
  • GLOBAL FUNCTION [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    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.

  • GLOBAL FUNCTION [ Time Frame: At month 3 ] [ Designated as safety issue: No ]
    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.

  • GLOBAL FUNCTION [ Time Frame: At month 6 ] [ Designated as safety issue: No ]
    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.

  • GLOBAL FUNCTION [ Time Frame: At month 9 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • DEMOGRAPHIC AND CLINICAL DATA [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    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)

  • PAIN CATASTROPHIZING [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    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.

  • ANXIETY AND DEPRESSION [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    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.

  • PSYCHIATRIC DIAGNOSIS [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    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.

  • PAIN [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    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)

  • COST-EFFECTIVENESS ANALYSIS [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    COST-EFFECTIVENESS ANALYSIS: Includes a) Drug profile, and b) Services.

  • PAIN ACCEPTANCE [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
    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.

  • CORDANCE [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    CORDANCE: the Fast Fourier Transform (FFT) will be applied to artefact-free electroencephalogram activity segments to calculate absolute and relative powers for each electrode.

  • PAIN CATASTROPHIZING [ Time Frame: At month 3 ] [ Designated as safety issue: No ]
    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.

  • PAIN CATASTROPHIZING [ Time Frame: At month 6 ] [ Designated as safety issue: No ]
    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.

  • ANXIETY AND DEPRESSION [ Time Frame: At month 3 ] [ Designated as safety issue: No ]
    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.

  • ANXIETY AND DEPRESSION [ Time Frame: At month 6 ] [ Designated as safety issue: No ]
    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.

  • PAIN [ Time Frame: At month 3 ] [ Designated as safety issue: No ]
    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)

  • PAIN [ Time Frame: At month 6 ] [ Designated as safety issue: No ]
    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)

  • COST-EFFECTIVENESS ANALYSIS [ Time Frame: At month 3 ] [ Designated as safety issue: No ]
    COST-EFFECTIVENESS ANALYSIS: Includes a) Drug profile, and b) Services.

  • COST-EFFECTIVENESS ANALYSIS [ Time Frame: At month 6 ] [ Designated as safety issue: No ]
    COST-EFFECTIVENESS ANALYSIS: Includes a) Drug profile, and b) Services.

  • COST-EFFECTIVENESS ANALYSIS [ Time Frame: At month 9 ] [ Designated as safety issue: No ]
    COST-EFFECTIVENESS ANALYSIS: Includes a) Drug profile, and b) Services.

  • PAIN ACCEPTANCE [ Time Frame: At month 3 ] [ Designated as safety issue: No ]
    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.

  • PAIN ACCEPTANCE [ Time Frame: At month 6 ] [ Designated as safety issue: No ]
    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.

  • PAIN ACCEPTANCE [ Time Frame: At month 9 ] [ Designated as safety issue: No ]
    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.

  • CORDANCE [ Time Frame: At month 3 ] [ Designated as safety issue: No ]
    CORDANCE: the Fast Fourier Transform (FFT) will be applied to artefact-free electroencephalogram activity segments to calculate absolute and relative powers for each electrode.


Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Improved Treatment as Usual

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611831

Locations
Spain
Mental Health Unit, Primary Care Center "Torrero-La Paz"
Zaragoza, Spain, 50009
Sponsors and Collaborators
Dr. Marta Alda
Instituto Aragones de Ciencias de la Salud
Carlos III Health Institute
Investigators
Principal Investigator: Marta Alda Hospital Miguel Servet
  More Information

Publications:

Responsible Party: Dr. Marta Alda, Principal Investigator, Hospital Miguel Servet
ClinicalTrials.gov Identifier: NCT01611831     History of Changes
Other Study ID Numbers: PI11/024
Study First Received: May 11, 2012
Last Updated: June 4, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Miguel Servet:
fibromyalgia
Acceptation & Commitment Therapy
randomized controlled trial

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 16, 2014