FibromyalgiaDOLORTRATPSINCT03992612
Efficacy of Psychological Therapy in Chronic Pain and Fibromyalgia
A study testing MBPM- Mindfulness-Based Pain Management in people with Fibromyalgia and Chronic Pain, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.
Trial summary
Today, one of the most important challenges of the health system is the attitude towards chronic disorders. That implies changing from a health structure established for the treatment of acute diseases to a continued care system. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia, Chronic Pain
- What is being tested?
- MBPM- Mindfulness-Based Pain Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2019to 30 Jun 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to complete the assessment protocol
- Suffer from chronic non-oncological pain, lasting longer than 6 months
- Not being receiving psychological treatment
- Sign the informed consent
Who cannot join
- Present a cognitive impairment, such as a dementia
- Present a diagnosis of a psychotic disease, bipolar disease or additive disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Mindfulness-based Pain Management in Patients With Chronic Pain With and Without Fibromyalgia
Today, one of the most important challenges of the health system is the attitude towards chronic disorders. That implies changing from a health structure established for the treatment of acute diseases to a continued care system.
In this sense, the approach of chronic pain, of non-oncological origin, supposes an important care challenge, to which this project wishes to respond.
Read more
Chronic pain affects one of every Europeans (19%), and has a prevalence of 11% in Spain, being one of the most important causes of medical consultation and is associated with high personal, social and economic costs. For example, in 2017 it was calculated that it has an economic impact of between 1.7 and 2.1% of Spain's GDP.
Referred to the psychological consequences of the disease, it has been found that 42% of people who have chronic pain suffer insomnia, a 40% anxiety, and 24% depressive symptoms. Hence the importance of implementing evidence-based psychological treatments along with their treatment as usual The main objective is comparing the efficacy of mindfulness-based pain management (MBPM), together with the usual medical treatment, in patients diagnosed with chronic pain, with and without comorbid fibromyalgia.
Specific objectives are:
- To study the sociodemographic and clinical profile of patients with chronic pain, with and without fibromyalgia.
- Define the characteristics of patients who are in the different stages of the disease: stage 1 (less than two years since diagnosis); stage 2 (between 2 and 4 years); stage 3 (between 5 and 8 years), and stage 4 (more than 8 years).
- Check the effectiveness of psychological therapies MBPM depending on the presence of fibromyalgia.
- Check the effectiveness of the psychological treatment in function of the stage of the disease.
Method:
A quasi-experimental design of two groups will be used. Patients will be assigned to experimental group: 50 subjects will receive MBPM and control group 40 subjects, 3-months wait list, after which time they will also receive MBPM.
All the participants will be assessed in the baseline; at the end of the treatment; and in the 1, 3, 6 and 12 months follow-ups. Group 2 (waiting list) will be assessed in the baseline, and re-assessed before starting the treatment; at the end of the psychological therapy; and in the 1, 3, 6 and 12 months follow-ups.
Read the detailed description
The objetive of this research are the study of efficacy in chronic pain and fybromyalgia of mindfulness therapy.
- Conditions
- Fibromyalgia, Chronic Pain
- Being tested
- control group: usual medical care, MBPM- Mindfulness-Based Pain Management
- Keywords
- Fibromyalgia, Chronic Pain, Psychological Treatment, Effectiveness, MBPM
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control group: usual medical careOther
The patients received usual medical care.
MBPM- Mindfulness-Based Pain ManagementBehavioural
8 group session of maindfulness-based treatment to management pain
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | The patients received usual medical care. Receives: Other: control group: usual medical care |
| MBPM- Minfulness- Based Pain Management | Experimental | Psychological intervention with 8 group sessions ( 8 -10 subjects) with a duration of 2 and a half hours per session and a weekly periodicity (total hours 1080).
It is centered on training on the awareness of physical, cognitive and emotional sensations, and the attentional processes to become an observer of one's own thoughts and emotions. With the aim to provide greater flexibility to manage pain Receives: Behavioral: MBPM- Mindfulness-Based Pain Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lattinen Index- IL
It is a scale with five items to assess variables associated with pain: frequency, intensity, disability, drugs usage and sleep problems. These are assessed by a Likert scale of 0 to 4, in order to explain the discomfort that pain generates. (Gonzalez-Escada, 2012)
Measured: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Secondary outcomes (8)
Change in the Fibromyalgia Impact Questionnaire- FIQ
its a 10 item scale that assesses the impact of the disease. The first item evaluates the interference of the disease in skills such as home care and work. The second item assesses how they felt last week; the third item values the days of last week that the disease prevented him from performing his usual tasks. Finally, the fourth item assesses the interference caused by pain and other items of the disease.
It will only be completed by patients diagnosed with fibromyalgia. (Esteve et al., 2007)
Measured: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Change in the Listado de Sintomas Breve- LSB-50
it is composed of 50 items, which are rated on a Likert scale from 0 to 4, depending on the level of discomfort caused by each item to the subject. it includes two scales of validity, three general indices, clinical scales (psychoreactivity, hypersensitivity, obsession, anxiety, hostility, somatization, depression, and sleep disturbances) and a psychological risk index. (de Rivera \& Abuin, 2012)
Measured: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Change in the Short Form 12 Health Survey- SF-12
It assesses a patient's health perception in 12 areas like physical function, physical role, body pain, general health, vitality, social function, emotional role, and mental health.
It is completed with Likert type response options from 3 to 5 points.(Schmidt et al., 2012)
Measured: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Change in Cuestionario de afrontamiento del dolor- CAD-R
It consists of 31 items related to the strategies that the patient performs when suffer pain. The strategies are valued from 1 (never use) to 5 (always use). The items are grouped into the following factors: religion, catharsis, distraction, information search, self-control, and self-affirmation. (Soriano \& Monsaslve, 2002)
Measured: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Change in Connor-Davison Resilience Scale- CDRISC
The CD-RISC scale assesses resilience. Consist in 25 items and the subject has to indicate what extent each of the statements has been true, in his case, during the last month on a scale ranging from 0 (not true at all) to 4 (almost always true). Fernández-Lansac \& Soberón, 2014)
Measured: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Change in Inventaire of negative thoughts in response to pain- INTRP
This questionnaire assesses the presence of negative thinking in response to pain. It consists of 21 items distributed in 5 factors: general negative thoughts, negative social thoughts, thoughts of disability, thoughts of lack of control, and thoughts of self-blame (Cano \& Rodriguez, 2002)
Measured: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Change Pain Catastrophizing Scale- PCS
The scale evaluates through 13 items the thoughts and feelings related to the experiences of pain. It is divided into three subscales, scored from 0 (never) to 4 (always), rumination, desperation, and magnification (Lami et al., 2013)
Measured: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Change in Chronic Pain Acceptance Questionnaire- CPAQ
The scale evaluates strategies of the pain experience. It consists of 20 items, scored from 0 (never true) to 6 (always true), from which three scores are obtained: involvement in activities, openness to pain, and total punctuation.
Measured: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Jun 2019
- Primary completion30 Jan 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Basque Country (UPV/EHU)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karmele Salaberria, University of the Basque Country (UPV/EHU)
- Investigators
- Karmele Salaberria, PH.D, Principal investigator, University of Basque Country
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992612
- Sponsor's protocol ID
- PI2018162
- Acronym
- DOLORTRATPSI
- Status last verified
- Mar 2022
- First submitted
- 14 Jun 2019
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mindfulness-based Pain Management in Patients With Chronic Pain With and Without Fibromyalgia
- ClinicalTrials.gov ID
- NCT03992612
- Acronym / sponsor ID
- DOLORTRATPSI / PI2018162
- Conditions
- Fibromyalgia, Chronic Pain
- Keywords
- Fibromyalgia, Chronic Pain, Psychological Treatment, Effectiveness, MBPM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of the Basque Country (UPV/EHU)University, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 20 Jun 2019 (actual)
- 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.
Today, one of the most important challenges of the health system is the attitude towards chronic disorders. That implies changing from a health structure established for the treatment of acute diseases to a continued care system.
In this sense, the approach of chronic pain, of non-oncological origin, supposes an important care challenge, to which this project wishes to respond.
Chronic pain affects one of every Europeans (19%), and has a prevalence of 11% in Spain, being one of the most important causes of medical consultation and is associated with high personal, social and economic costs. For example, in 2017 it was calculated that it has an economic impact of between 1.7 and 2.1% of Spain's GDP.
Referred to the psychological consequences of the disease, it has been found that 42% of people who have chronic pain suffer insomnia, a 40% anxiety, and 24% depressive symptoms. Hence the importance of implementing evidence-based psychological treatments along with their treatment as usual The main objective is comparing the efficacy of mindfulness-based pain management (MBPM), together with the usual medical treatment, in patients diagnosed with chronic pain, with and without comorbid fibromyalgia.
Specific objectives are:
- To study the sociodemographic and clinical profile of patients with chronic pain, with and without fibromyalgia.
- Define the characteristics of patients who are in the different stages of the disease: stage 1 (less than two years since diagnosis); stage 2 (between 2 and 4 years); stage 3 (between 5 and 8 years), and stage 4 (more than 8 years).
- Check the effectiveness of psychological therapies MBPM depending on the presence of fibromyalgia.
- Check the effectiveness of the psychological treatment in function of the stage of the disease.
Method:
A quasi-experimental design of two groups will be used. Patients will be assigned to experimental group: 50 subjects will receive MBPM and control group 40 subjects, 3-months wait list, after which time they will also receive MBPM.
All the participants will be assessed in the baseline; at the end of the treatment; and in the 1, 3, 6 and 12 months follow-ups. Group 2 (waiting list) will be assessed in the baseline, and re-assessed before starting the treatment; at the end of the psychological therapy; and in the 1, 3, 6 and 12 months follow-ups.
Detailed description
The objetive of this research are the study of efficacy in chronic pain and fybromyalgia of mindfulness therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: control group: usual medical careThe patients received usual medical care. |
| MBPM- Minfulness- Based Pain Management | Experimental | Behavioral: MBPM- Mindfulness-Based Pain ManagementPsychological intervention with 8 group sessions ( 8 -10 subjects) with a duration of 2 and a half hours per session and a weekly periodicity (total hours 1080). It is centered on training on the awareness of physical, cognitive and emotional sensations, and the attentional processes to become an observer of one's own thoughts and emotions. With the aim to provide greater flexibility to manage pain |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be able to complete the assessment protocol
- Suffer from chronic non-oncological pain, lasting longer than 6 months
- Not being receiving psychological treatment
- Sign the informed consent
Key exclusion criteria (2 listed)
- Present a cognitive impairment, such as a dementia
- Present a diagnosis of a psychotic disease, bipolar disease or additive disease
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 |
|---|---|---|
| control group: usual medical careThe patients received usual medical care. | Other | control group |
| MBPM- Mindfulness-Based Pain Management8 group session of maindfulness-based treatment to management pain | Behavioural | MBPM- Minfulness- Based Pain Management |
Primary outcome
Change in Lattinen Index- IL
Time frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
It is a scale with five items to assess variables associated with pain: frequency, intensity, disability, drugs usage and sleep problems. These are assessed by a Likert scale of 0 to 4, in order to explain the discomfort that pain generates. (Gonzalez-Escada, 2012)
8 secondary outcomes
Change in the Fibromyalgia Impact Questionnaire- FIQ
Time frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Change in the Listado de Sintomas Breve- LSB-50
Time frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Change in the Short Form 12 Health Survey- SF-12
Time frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Change in Cuestionario de afrontamiento del dolor- CAD-R
Time frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Change in Connor-Davison Resilience Scale- CDRISC
Time frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Change in Inventaire of negative thoughts in response to pain- INTRP
Time frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Change Pain Catastrophizing Scale- PCS
Time frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Change in Chronic Pain Acceptance Questionnaire- CPAQ
Time frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
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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.
Karmele Salaberria, PH.D principal investigator
University of Basque Country
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBPM- Mindfulness-Based Pain Management in people with Fibromyalgia and Chronic Pain, run by University of the Basque Country (UPV/EHU) 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 4 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: finished, as of the sponsor's last update on 16 Mar 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Lattinen Index- IL (time frame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2022.