Stress Reduction Program Based on Mindfulness for Patients With Discopathies

This study evaluates the influence of stress on inflammation and the symptomatology of the patient with back pain. Mindfulness Based Stress Reduction (MBSR) will be used in half of participants, a validated psychopedagogical intervention for stress reduction, and the participants assigned to the control group will follow the usual treatment, according to their diagnosis.

Study Overview

• Status: Completed
• Conditions: Back Pain
• Intervention / Treatment: Other: Mindfulness Based Stress Reduction (MBSR)

Detailed Description

The Mindfulness based stress reduction (MBSR) is a psycho-educational program of stress reduction based on mindfulness. It consists of a program of 30 hours of duration divided into 9 sessions with a weekly frequency of 2.5 h and an intensive session between the week 6 and 7 of the program with a duration of 7.5 hours. Each week, the theoretical contents that are necessary to understand the attention development practices will be covered. In addition, basic concepts of the psychobiology and psychology of stress and pain will be explained. The subjects will have a homework load of approximately 45 minutes per day during the intervention program.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alava
    • Vitoria, Alava, Spain, 01007
      • Fundación Eduardo Anitua
  • Colmenarejo
    • Madrid, Colmenarejo, Spain, 28070
      • Instituto de Investigación y Formación en Ciencias Cognitivas - Nirakara
  • Somosaguas
    • Madrid, Somosaguas, Spain, 28223
      • Facultad de Psicología de la Universidad Complutense de Madrid.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• To be diagnosed with symptomatic disc disease (Participants must provide a medical report that certifies the discopathy).
• Normal or moderate mobility
• Normal cognitive state
• Patients who have previously read and signed the informed consent.
• Patients that are capable and willing to comply with the study procedures.

Exclusion Criteria:

• Serious psychopathologies
• Suicidal thoughts.
• Deep depression
• Psychosis
• Drug addiction
• Very limited functional capacity and cognitive impairment: Patientsconfined in a bed or a chair. They need the help of a third person.
• Do not incorporate during the program any clinical, psychological or pharmacological treatments different from those ones that are normally used to controlled the pain, or any drastic changes in lifestyle.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Based Stress Reduction (MBSR); Program of 30 hours of duration divided into 9 sessions with a weekly frequency of 2.5 h and an intensive session between week 6 and 7 of the program with a duration of 7.5 hours.	Other: Mindfulness Based Stress Reduction (MBSR); Psycho-educational program of stress reduction based on mindfulness. Program of 30 hours of duration divided into 9 sessions with a weekly frequency of 2.5 h and an intensive session between week 6 and 7 of the program with a duration of 7.5 hours. Each week the theoretical contents necessary to understand the attention development practices proposed in mindfulness-based interventions will be covered. In addition, basic concepts of the psychobiology and psychology of stress and pain are explained. The subjects will have a homework load of approximately 45 minutes per day during the duration of the intervention.
No Intervention: Control; Participants assigned to the control group will follow the usual treatment, according to their diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress change	Measured with the variation of cortisol in blood. These samples are obtained from a blood test that will be done to the participants before and after starting the experimental and control programs.	Baseline and Six months
Variation of cytokines	((TNF) -α and interleukin (IL) -1β, IL-6 and IL17), as an approximate biomarker of inflammation. Bio-chemical markers of the discopathy: Cytokines ((TNF) -α, interleukin (IL) -1β, IL-6 and IL-17). These samples are obtained from a blood test that will be done to the participants before and after starting the experimental and control programs.	Baseline and Six months
Variation of the nocturnal apnea index.	Sleep and breathing analysis: The performance of the sleep and breathing registration tests will be carried out in the patient's home. The sleep study will be done with a validated respiratory polygraphy (BTI-APNiA®). The sleep analysis will be controlled by a sleep technician and supervised by a sleep medicine specialist. The sleep analysis will be done to the participants before and after starting the experimental and control programs.	Baseline and Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Five Facet Mindfulness Questionnaire (FFMQ)	39 items scale that offers a total score of a person's level of mindfulness.	Baseline and Six months
Self-Compassion Scale (SCS)	Evaluates the person's ability to be kind and understanding with themselves. The scale consists of 26 items scored on a 5-point likert scale.	Baseline and Six months
Perceived Stress Scale (PSS)	Evaluates the level of perceived stress during the last month. It consists of 14 items scored on a Likert scale from 0 to 4.	Baseline and Six months
DASS-21	Scale designed to assess negative mood by means of three subscales: stress, anxiety and depression. The scale has 21 items scored on a Likert scale from 0 to 3.	Baseline and Six months
Chronic Pain Grade Scale (CPGS; 90)	Scale that assesses the intensity of pain and disability caused by pain. It is a widely used measure for the evaluation of chronic musculoskeletal pain and back pain. The scale consists of 7 items scored on a Likert scale from 0 to 10.	Baseline and Six months
Brief Pain Inventory (BPI)	It measures both the intensity of pain (sensory dimension) and the interference of pain in the patient's life (reactive dimension) in patients with chronic pain caused by osteoarthritis, back pain and cancer.	Baseline and Six months
Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)	Instrument designed to assess the acceptance of pain. The scale consists of 20 items scored on a Likert scale from 0 to 6.	Baseline and Six months
Pain Catastrophising Scale (PCS)	Evaluates the tendency to magnify the threat of a painful stimulus and the feeling of helplessness in the presence of pain, as well as the inability to prevent or inhibit thoughts related to pain (both before, during, and after the painful event). The scale consists of 13 items scored on a Likert scale from 0 to 4.	Baseline and Six months
Brief Fatigue Inventory (BFI)	The objective of this scale is to assess the severity of fatigue and the impact of fatigue caused by pain in the daily functioning of people. The scale consists of 9 items scored on a scale likert type from 0 to 10.	Baseline and Six months
Pain Self-Efficacy Questionnaire (PSEQ)	Evaluates to what extent a person with pain believes they are capable of performing their daily activities regardless of their pain. The scale consists of 10 items scored on a scale likert type from 0 to 6.	Baseline and Six months
Survey of Pain Attitudes - Brief (SOPA-B)	Evaluates the patient's attitude to seven dimensions of the experience of chronic pain: control of pain, disability associated with pain, medical cues of pain, request for help from others when in pain, medication for pain, the influence of emotions on pain and pain as an indicator of physical damage. The scale consists of 30 items scored on a Likert scale from 0 to 4.	Baseline and Six months
Pain Coping Inventory (PC)	Instrument designed to evaluate the pain coping strategies used by patients with chronic pain. The scale consists of 34 items scored on a Likert scale from 1 to 4.	Baseline and Six months
Short Form-36 Bodily Pain Scale (SF-36 BPS)	It is one of the eight subscales of the SF-36 questionnaire (Ware, Kosinski & Keller, 1994) designed as a generic measure of health status for population studies.	Baseline and Six months
Pain and Sleep Questionnaire (PSQ)	Evaluates the impact of chronic pain on sleep quality. The scale consists of 8 items scored on a visual analog scale from 0 to 100.	Baseline and Six months
Satisfaction with Life questionnaire (SWLS)	5-item brief scale designed to measure a person's overall cognitive judgments about their satisfaction with life.	Baseline and Six months
WHO-5 Well Being Index	5 item scale designed to evaluate the subjective psychological well-being of the person.	Baseline and Six months

Collaborators and Investigators

• Sponsor: Fundación Eduardo Anitua
• Collaborators: Universidad Complutense de Madrid; Instituto de Investigación y Formación en Ciencias Cognitivas - Nirakara

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: April 2, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: FIBEA-01-EC/18/MIND

Drug and device information, study documents

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