Efficacy of Psychological Therapy in Chronic Pain and Fibromyalgia (DOLORTRATPSI)

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.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Fibromyalgia
• Intervention / Treatment: Other: control group: usual medical care; Behavioral: MBPM- Mindfulness-Based Pain Management

Detailed Description

The objetive of this research are the study of efficacy in chronic pain and fybromyalgia of mindfulness therapy.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Guipuzcoa
    • San Sebastián, Guipuzcoa, Spain, 20018
      • University of Basque Country

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: control group; The patients received usual medical care.	Other: control group: usual medical care; The patients received usual medical care.
EXPERIMENTAL: 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	Behavioral: MBPM- Mindfulness-Based Pain Management; 8 group session of maindfulness-based treatment to management pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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)	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)	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)	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.	base line (week 0), end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire	This scale assesses clients satisfaction with the treatment through 8 items, using a Likert scale from 0 to 4. (Larsen et al., 1978)	end of treatment (week 12); and during maintenance phase (weeks 17, 29 and 41)

Collaborators and Investigators

• Sponsor: University of the Basque Country (UPV/EHU)
• Investigators: Principal Investigator: Karmele Salaberria, PH.D, University of Basque Country

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ACTUAL): January 30, 2021
• Study Completion (ACTUAL): June 30, 2021

Study Registration Dates

• First Submitted: June 14, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (ACTUAL): June 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Chronic Pain; Fibromyalgia; Effectiveness; Psychological Treatment; MBPM
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Chronic Pain; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: PI2018162

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No