FibromyalgiaACTGROUPNCT01611831

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

A study testing ACT in group and Improved treatment as usual by General Practitioners in people with Fibromyalgia, run by Dr. Marta Alda at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Fibromyalgia
What is being tested?: ACT in group and Improved treatment as usual by General Practitioners
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteSpain
Study dates: Jan 2012to Jan 2013
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Spain1 site

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

Other trials in Spain

About this study

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

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.

Read the 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.

Conditions: Fibromyalgia
Being tested: ACT in group, Improved treatment as usual by General Practitioners
Keywords: fibromyalgia, Acceptation & Commitment Therapy, randomized controlled trial
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ACT in groupBehavioural
Also called 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.
Improved treatment as usual by General PractitionersBehavioural
Also called 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.

Study groups in NCT01611831
Study group	Role	What they receive
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). Receives: 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. Receives: Behavioral: Improved treatment as usual by General Practitioners

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At month 9

Secondary outcomes (21)

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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: At baseline
COST-EFFECTIVENESS ANALYSIS
COST-EFFECTIVENESS ANALYSIS: Includes a) Drug profile, and b) Services.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: At month 6
COST-EFFECTIVENESS ANALYSIS
COST-EFFECTIVENESS ANALYSIS: Includes a) Drug profile, and b) Services.
Measured: At month 3
COST-EFFECTIVENESS ANALYSIS
COST-EFFECTIVENESS ANALYSIS: Includes a) Drug profile, and b) Services.
Measured: At month 6
COST-EFFECTIVENESS ANALYSIS
COST-EFFECTIVENESS ANALYSIS: Includes a) Drug profile, and b) Services.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Jan 2013

First posted5 Jun 2012 (estimated)
Study startJan 2012
Primary completionJul 2012 (estimated)
Study completionJan 2013 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01611831
Sponsor's protocol ID: PI11/024
Acronym: ACTGROUP
Status last verified: May 2012
First submitted: 11 May 2012
Last updated: 5 Jun 2012
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 2306288
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.
PubMed 11437810
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.
PubMed 14760810
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.
PubMed 9514556
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.
PubMed 14715402
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.
PubMed 9343572
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.
PubMed 16300724
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.
PubMed 16516066
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.
PubMed 17400387
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.
PubMed 19007576
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.
PubMed 19389246
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.
PubMed 18627602

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Acceptance and Commitment Therapy (ACT) in Group in Fibromyalgia: a Randomized, Controlled Study.
ClinicalTrials.gov ID: NCT01611831
Acronym / sponsor ID: ACTGROUP / PI11/024
Conditions: Fibromyalgia
Keywords: fibromyalgia, Acceptation & Commitment Therapy, randomized controlled trial
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: Dr. Marta AldaUniversity, hospital or other
Collaborators: Instituto Aragones de Ciencias de la Salud, Carlos III Health Institute
Study start: Jan 2012
Primary completion: Jul 2012 (estimated)
Study completion: Jan 2013 (estimated)
First posted: 5 Jun 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ACT in group	Experimental	Behavioral: ACT in groupPatients 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).
Improved Treatment as usual by General practitioner	Active comparator	Behavioral: Improved treatment as usual by General PractitionersPatients 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (2 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ACT in groupAlso: 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.	Behavioural	ACT in group
Improved treatment as usual by General PractitionersAlso: Improved Treatment as UsualGeneral 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.	Behavioural	Improved Treatment as usual by General practitioner

Primary outcome

GLOBAL FUNCTION
Time frame: At baseline
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
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
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
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.

21 secondary outcomes

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2012.
Background: PubMed 2306288Wolfe 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.
Background: PubMed 11437810Garcia-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.
Background: PubMed 14760810Cook 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.
Background: PubMed 9514556McCracken 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.
Background: PubMed 14715402McCracken 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.
Background: PubMed 9343572Leuchter 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.
Background: PubMed 16300724Hayes 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.
Background: PubMed 16516066Garcia-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.
Background: PubMed 17400387Garcia-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.
Background: PubMed 19007576Garcia 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.
Background: PubMed 19389246Garcia-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.
Background: PubMed 18627602Garcia-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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marta Alda principal investigator

Hospital Miguel Servet

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ACT in group and Improved treatment as usual by General Practitioners in people with Fibromyalgia, run by Dr. Marta Alda at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

GLOBAL FUNCTION (time frame: At baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01611831, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2012.