Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Fibromyalgia is a long-term (chronic) condition that causes pain all over the body. The effects of psychological treatments for fibromyalgia are relatively small but comparable to those reported for drug treatments used for this disorder. Acceptance and commitment therapy, a form of talking therapy, is a promising treatment for chronic pain disorders, but so far there are no studies on fibromyalgia. The aim of this study is to assess the effectiveness of group acceptance and commitment therapy for the treatment of fibromyalgia.

Who can participate?
Patients aged 18–65 with fibromyalgia

What does the study involve?
Participants are randomly allocated to one of three groups. Participants in the first group attend an 8-week group acceptance and commitment therapy program. Participants in the second group receive the recommended pharmacological (drug) treatment for fibromyalgia. Participants in the third group are put on a waiting list for treatment. Fibromyalgia symptoms are assessed in all three groups after 6 months.

What are the possible benefits and risks of participating?
Possible benefits include an improvement in fibromyalgia symptoms with either of the two treatments as has been demonstrated in previous studies. The risks in the acceptance and commitment therapy group are minimal. In the drug treatment group the drugs used may have minor side effects.

Where is the study run from?
Spanish Research Network of Preventative Activities in Primary Care, Instituto de Salud Carlos III, from the Spanish Ministry of Health

When is the study starting and how long is it expected to run for?
September 2012 to June 2013

Who is funding the study?
Spanish Research Network of Preventative Activities in Primary Care, Instituto de Salud Carlos III, from the Spanish Ministry of Health

Who is the main contact?
Prof. Javier Garcia-Campayo

Trial website

Contact information



Primary contact

Prof Javier Garcia-Campayo


Contact details

Miguel Servet University Hospital
Avda Isabel la Catolica 1
+34 (0)976 253621

Additional identifiers

EudraCT number number

Protocol/serial number

Protocol 7/2011

Study information

Scientific title

EFFIcacy of Group Acceptance & Commitment Therapy in fibromyalgia (EFFIGACT): a three-armed randomized controlled trial



Study hypothesis

Group acceptance & commitment therapy will be more effective than recommended pharmacological treatment and more effective than wait-list for the treatment of fibromyalgia (FM).

Ethics approval

Aragón Ethical Review Board, 06/05/2011, ref: 07/2011

Study design

Randomized controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Fibromyalgia (chronic pain conditions)


Patients with FM will be randomly assigned to:

Group Acceptance & Commitment Therapy (GACT):
Consists of an 8-week structured program in groups (90 minutes duration, 12-15 participants in each group) based on Acceptance & Commitment Therapya and specifically tailored for fibromyalgia.

Recommended pharmacological treatment:
Pharmacological treatment as recommended by Clinical Guidelines. In summary, main treatment: pregabaline (300-600mg/day), and whether depression is diagnosed duloxetine (60-120 mg/day). Analgesics, hypnotics and other symptomatic treatments are allowed following guides.

No active treatment will be offered during the period of study.

Intervention type



Drug names

Primary outcome measure

Fibromyalgia Impact Questionnaire (FIQ) - a 10-item self-report questionnaire developed to measure the health status of FM patients

Secondary outcome measures

1. Sociodemographic variables (gender, age, marital status, ethnic group, living arrangements, educational level, employment status and income)
2. Psychiatric diagnosis (assessed with MINI)
3. Pain catastrophising scale
4. Pain visual analog scale
5. Chronic Pain Acceptance Questionnaire
6. Pain threshold assessed by sphygmomanometer
7. Hospital Anxiety Depression Scale

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Patients will be recruited from the primary care health centres in the region of Aragon, Spain
2. Patients aged 18–-65 years, able to understand and read Spanish
3. Patients who fulfil criteria for FM according to the American College of Rheumatology criteria
4. Patients with no previous psychological treatment during previous year
5. Patients with signed informed consent

Participant type


Age group




Target number of participants

150 participants, 50 patients in each of the three arms.

Participant exclusion criteria

1. Patients with severe Axis I psychiatric disorders (dementia, schizophrenia, paranoid disorder, alcohol and/or drug use disorders)
2. Patients with severe somatic disorders which, from the clinician’s point of view, prevent patients from carrying out a psychological assessment
3. Patients participating in other clinical trials

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Miguel Servet University Hospital

Sponsor information


Miguel Servet University Hospital (Spain)

Sponsor details

c/o Javier Garcia Campayo
Department if Psychiatry
Avda Isabel La Catolica 1
+34 (0)976 253621

Sponsor type

Hospital/treatment centre



Funder type

Research organisation

Funder name

The Aragon Health Sciences Institute [Instituto Aragonés de Ciencias de la Salud (I+CS)] (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

The Research Network on Preventative Activities and Health Promotion [Red de Actividades Preventivas y de Promoción de la Salud (REDIAPP)] (Spain) ref: B76 & RD06/0018/0020

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2013 results in:

Publication citations

  1. Results

    Luciano JV, Guallar JA, Aguado J, López-Del-Hoyo Y, Olivan B, Magallón R, Alda M, Serrano-Blanco A, Gili M, Garcia-Campayo J, Effectiveness of group acceptance and commitment therapy for fibromyalgia: a 6-month randomized controlled trial (EFFIGACT study)., Pain, 2014, 155, 4, 693-702, doi: 10.1016/j.pain.2013.12.029.

Additional files

Editorial Notes

11/08/2016: Plain English summary added.