Efficacy of group acceptance & commitment therapy in fibromyalgia
| ISRCTN | ISRCTN96465010 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96465010 |
| Secondary identifying numbers | Protocol 7/2011 |
- Submission date
- 11/08/2012
- Registration date
- 16/08/2012
- Last edited
- 11/08/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
jgarcamp@arrakis.es
Contact information
Scientific
Miguel Servet University Hospital
Avda Isabel la Catolica 1
Zaragoza
50009
Spain
| Phone | +34 (0)976 253621 |
|---|---|
| jgarcamp@arrakis.es |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | EFFIcacy of Group Acceptance & Commitment Therapy in fibromyalgia (EFFIGACT): a three-armed randomized controlled trial |
| Study acronym | EFFIGACT |
| Study objectives | 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(s) | Aragón Ethical Review Board, 06/05/2011, ref: 07/2011 |
| Health condition(s) or problem(s) studied | Fibromyalgia (chronic pain conditions) |
| Intervention | 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. Wait-list: No active treatment will be offered during the period of study. |
| Intervention type | Mixed |
| 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 study start date | 01/09/2012 |
| Completion date | 30/06/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 150 participants, 50 patients in each of the three arms. |
| Key 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 |
| Key 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 clinicians point of view, prevent patients from carrying out a psychological assessment 3. Patients participating in other clinical trials |
| Date of first enrolment | 01/09/2012 |
| Date of final enrolment | 30/06/2013 |
Locations
Countries of recruitment
- Spain
Study participating centre
50009
Spain
Sponsor information
Hospital/treatment centre
c/o Javier Garcia Campayo
Department if Psychiatry
Avda Isabel La Catolica 1
Zaragoza
50009
Spain
| Phone | +34 (0)976 253621 |
|---|---|
| jgarcamp@arrakis.es | |
| Website | http://sectorzaragozados.salud.aragon.es/ |
"ROR" |
https://ror.org/01r13mt55 |
Funders
Funder type
Research organisation
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2014 | Yes | No |
Editorial Notes
11/08/2016: Plain English summary added.
