Stress Reduction Program Based on Mindfulness for Patients With Discopathies

Back Pain Clinical Trial

Official title:

Stress Reduction Program Based on Mindfulness for Patients With Discopathies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911375
• Other study ID #: FIBEA-01-EC/18/MIND
• Status: Completed
• Phase: N/A
• Start date: April 3, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: July 2021
• Source: Fundación Eduardo Anitua
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain

Intervention

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.

Locations

Country	Name	City	State
Spain	Facultad de Psicología de la Universidad Complutense de Madrid.	Madrid	Somosaguas
Spain	Instituto de Investigación y Formación en Ciencias Cognitivas - Nirakara	Madrid	Colmenarejo
Spain	Fundación Eduardo Anitua	Vitoria	Alava

Sponsors (3)

Lead Sponsor	Collaborator
Fundación Eduardo Anitua	Instituto de Investigación y Formación en Ciencias Cognitivas - Nirakara, Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Variation of cytokines	((TNF) -a and interleukin (IL) -1ß, IL-6 and IL17), as an approximate biomarker of inflammation. Bio-chemical markers of the discopathy: Cytokines ((TNF) -a, interleukin (IL) -1ß, 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
Primary	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	Five Facet Mindfulness Questionnaire (FFMQ)	39 items scale that offers a total score of a person's level of mindfulness.	Baseline and Six months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pain Self-E?cacy 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	WHO-5 Well Being Index	5 item scale designed to evaluate the subjective psychological well-being of the person.	Baseline and Six months