Efficacy of Psychological Therapy in Chronic Pain and Fibromyalgia

NCT ID: NCT03992612

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2021-06-30

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.

Conditions

Fibromyalgia; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control group

The patients received usual medical care.

Group Type: OTHER

control group: usual medical care

Intervention Type: OTHER

The patients received usual medical care.

MBPM- Minfulness- Based Pain Management

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

Group Type: EXPERIMENTAL

MBPM- Mindfulness-Based Pain Management

Intervention Type: BEHAVIORAL

8 group session of maindfulness-based treatment to management pain

Interventions

control group: usual medical care

The patients received usual medical care.

Intervention Type: OTHER

MBPM- Mindfulness-Based Pain Management

8 group session of maindfulness-based treatment to management pain

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of the Basque Country (UPV/EHU)

OTHER

Sponsor Role: lead

Responsible Party

Karmele Salaberria

PhD. Lecturer in Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karmele Salaberria, PH.D

Role: PRINCIPAL_INVESTIGATOR

University of Basque Country

Locations

University of Basque Country

San Sebastián, Guipuzcoa, Spain

Countries

Spain

Other Identifiers

PI2018162

Identifier Type: -

Identifier Source: org_study_id