Stress Reduction Program Based on Mindfulness for Patients With Discopathies

NCT03911375 | Completed

• 1 other identifier: FIBEA-01-EC/18/MIND
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Back Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (16)

• Five Facet Mindfulness Questionnaire (FFMQ)

  Baseline and Six months

• Self-Compassion Scale (SCS)

  Baseline and Six months

• Perceived Stress Scale (PSS)

  Baseline and Six months

• DASS-21

  Baseline and Six months

• Chronic Pain Grade Scale (CPGS; 90)

  Baseline and Six months

Study Arms (2)

Mindfulness Based Stress Reduction (MBSR)

EXPERIMENTAL

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)

Control

NO INTERVENTION

Participants assigned to the control group will follow the usual treatment, according to their diagnosis.

Interventions

Mindfulness Based Stress Reduction (MBSR) OTHER

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.

Mindfulness Based Stress Reduction (MBSR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Eduardo Anitua: lead
• Instituto de Investigación y Formación en Ciencias Cognitivas - Nirakara: collaborator
• Universidad Complutense de Madrid: collaborator

Study Sites (3)

Fundación Eduardo Anitua

Vitoria-Gasteiz, Alava, 01007, Spain

Location

Instituto de Investigación y Formación en Ciencias Cognitivas - Nirakara

Madrid, Colmenarejo, 28070, Spain

Location

Facultad de Psicología de la Universidad Complutense de Madrid.

Madrid, Somosaguas, 28223, Spain

Location

MeSH Terms

Conditions

Back Pain

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 11, 2019
• Study Start: April 3, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: May 6, 2022

Record last verified: 2021-07

Locations

ES (3)