Clinical trial NCT03992612: Efficacy of Psychological Therapy in Chronic Pain and Fibromyalgia
Official title: Efficacy of Mindfulness-based Pain Management in Patients With Chronic Pain With and Without Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Chronic Pain
Keywords: Fibromyalgia
Chronic Pain
Psychological Treatment
Effectiveness
MBPM
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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:

1. To study the sociodemographic and clinical profile of patients with chronic pain, with and without fibromyalgia.
2. 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).
3. Check the effectiveness of psychological therapies MBPM depending on the presence of fibromyalgia.
4. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Present a cognitive impairment, such as a dementia
* Present a diagnosis of a psychotic disease, bipolar disease or additive disease

Primary outcomes:
measure: Change in Lattinen Index- IL
timeFrame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Secondary outcomes:
measure: Change in the Fibromyalgia Impact Questionnaire- FIQ
timeFrame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
measure: Change in the Listado de Sintomas Breve- LSB-50
timeFrame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
measure: Change in the Short Form 12 Health Survey- SF-12
timeFrame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
measure: Change in Cuestionario de afrontamiento del dolor- CAD-R
timeFrame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
measure: Change in Connor-Davison Resilience Scale- CDRISC
timeFrame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
measure: Change in Inventaire of negative thoughts in response to pain- INTRP
timeFrame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
measure: Change Pain Catastrophizing Scale- PCS
timeFrame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
measure: Change in Chronic Pain Acceptance Questionnaire- CPAQ
timeFrame: base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Other outcomes:
measure: Client Satisfaction Questionnaire
timeFrame: end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)
Locations:
city: San Sebastián
country: Spain
facility: University of Basque Country
state: Guipuzcoa
Study officials:
affiliation: University of Basque Country
name: Karmele Salaberria, PH.D
role: PRINCIPAL_INVESTIGATOR
References: