Stress Reduction Program Based on Mindfulness for Patients With Discopathies

• ClinicalTrials.gov Identifier: NCT03911375
• Recruitment Status: Active, not recruiting
• First Posted: April 11, 2019
• Last Update Posted: July 22, 2021
• Sponsor: Fundación Eduardo Anitua
• Collaborators: Instituto de Investigación y Formación en Ciencias Cognitivas - Nirakara; Universidad Complutense de Madrid
• Information provided by (Responsible Party): Fundación Eduardo Anitua

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Back Pain	Other: Mindfulness Based Stress Reduction (MBSR)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Stress Reduction Program Based on Mindfulness for Patients With Discopathies
• Actual Study Start Date: April 3, 2019
• Estimated Primary Completion Date: July 30, 2021
• Estimated Study Completion Date: July 30, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Stress change [ Time Frame: Baseline and Six months ]
   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.
2. Variation of cytokines [ Time Frame: Baseline and Six months ]
   ((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.
3. Variation of the nocturnal apnea index. [ Time Frame: Baseline and Six months ]
   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.

Secondary Outcome Measures :

1. Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: Baseline and Six months ]
   39 items scale that offers a total score of a person's level of mindfulness.
2. Self-Compassion Scale (SCS) [ Time Frame: Baseline and Six months ]
   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.
3. Perceived Stress Scale (PSS) [ Time Frame: Baseline and Six months ]
   Evaluates the level of perceived stress during the last month. It consists of 14 items scored on a Likert scale from 0 to 4.
4. DASS-21 [ Time Frame: Baseline and Six months ]
   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.
5. Chronic Pain Grade Scale (CPGS; 90) [ Time Frame: Baseline and Six months ]
   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.
6. Brief Pain Inventory (BPI) [ Time Frame: Baseline and Six months ]
   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.
7. Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R) [ Time Frame: Baseline and Six months ]
   Instrument designed to assess the acceptance of pain. The scale consists of 20 items scored on a Likert scale from 0 to 6.
8. Pain Catastrophising Scale (PCS) [ Time Frame: Baseline and Six months ]
   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.
9. Brief Fatigue Inventory (BFI) [ Time Frame: Baseline and Six months ]
   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.
10. Pain Self-Efficacy Questionnaire (PSEQ) [ Time Frame: Baseline and Six months ]
    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.
11. Survey of Pain Attitudes - Brief (SOPA-B) [ Time Frame: Baseline and Six months ]
    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.
12. Pain Coping Inventory (PC) [ Time Frame: Baseline and Six months ]
    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.
13. Short Form-36 Bodily Pain Scale (SF-36 BPS) [ Time Frame: Baseline and Six months ]
    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.
14. Pain and Sleep Questionnaire (PSQ) [ Time Frame: Baseline and Six months ]
    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.
15. Satisfaction with Life questionnaire (SWLS) [ Time Frame: Baseline and Six months ]
    5-item brief scale designed to measure a person's overall cognitive judgments about their satisfaction with life.
16. WHO-5 Well Being Index [ Time Frame: Baseline and Six months ]
    5 item scale designed to evaluate the subjective psychological well-being of the person.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Spain

Fundación Eduardo Anitua

Vitoria, Alava, Spain, 01007

Instituto de Investigación y Formación en Ciencias Cognitivas - Nirakara

Madrid, Colmenarejo, Spain, 28070

Facultad de Psicología de la Universidad Complutense de Madrid.

Madrid, Somosaguas, Spain, 28223

Sponsors and Collaborators

Fundación Eduardo Anitua

Instituto de Investigación y Formación en Ciencias Cognitivas - Nirakara

Universidad Complutense de Madrid

More Information

• Responsible Party: Fundación Eduardo Anitua
• ClinicalTrials.gov Identifier: NCT03911375
• Other Study ID Numbers: FIBEA-01-EC/18/MIND
• First Posted: April 11, 2019
• Last Update Posted: July 22, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Back Pain; Pain; Neurologic Manifestations