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Stress Reduction Program Based on Mindfulness for Patients With Discopathies

Primary Purpose

Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mindfulness Based Stress Reduction (MBSR)
Sponsored by
Fundación Eduardo Anitua
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fundación Eduardo Anitua
  • Instituto de Investigación y Formación en Ciencias Cognitivas - Nirakara
  • Facultad de Psicología de la Universidad Complutense de Madrid.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness Based Stress Reduction (MBSR)

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Five Facet Mindfulness Questionnaire (FFMQ)
39 items scale that offers a total score of a person's level of mindfulness.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Satisfaction with Life questionnaire (SWLS)
5-item brief scale designed to measure a person's overall cognitive judgments about their satisfaction with life.
WHO-5 Well Being Index
5 item scale designed to evaluate the subjective psychological well-being of the person.

Full Information

First Posted
April 2, 2019
Last Updated
May 5, 2022
Sponsor
Fundación Eduardo Anitua
Collaborators
Instituto de Investigación y Formación en Ciencias Cognitivas - Nirakara, Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT03911375
Brief Title
Stress Reduction Program Based on Mindfulness for Patients With Discopathies
Official Title
Stress Reduction Program Based on Mindfulness for Patients With Discopathies
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 3, 2019 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Eduardo Anitua
Collaborators
Instituto de Investigación y Formación en Ciencias Cognitivas - Nirakara, Universidad Complutense de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Based Stress Reduction (MBSR)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants assigned to the control group will follow the usual treatment, according to their diagnosis.
Intervention Type
Other
Intervention Name(s)
Mindfulness Based Stress Reduction (MBSR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stress change
Description
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.
Time Frame
Baseline and Six months
Title
Variation of cytokines
Description
((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.
Time Frame
Baseline and Six months
Title
Variation of the nocturnal apnea index.
Description
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.
Time Frame
Baseline and Six months
Secondary Outcome Measure Information:
Title
Five Facet Mindfulness Questionnaire (FFMQ)
Description
39 items scale that offers a total score of a person's level of mindfulness.
Time Frame
Baseline and Six months
Title
Self-Compassion Scale (SCS)
Description
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.
Time Frame
Baseline and Six months
Title
Perceived Stress Scale (PSS)
Description
Evaluates the level of perceived stress during the last month. It consists of 14 items scored on a Likert scale from 0 to 4.
Time Frame
Baseline and Six months
Title
DASS-21
Description
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.
Time Frame
Baseline and Six months
Title
Chronic Pain Grade Scale (CPGS; 90)
Description
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.
Time Frame
Baseline and Six months
Title
Brief Pain Inventory (BPI)
Description
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.
Time Frame
Baseline and Six months
Title
Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)
Description
Instrument designed to assess the acceptance of pain. The scale consists of 20 items scored on a Likert scale from 0 to 6.
Time Frame
Baseline and Six months
Title
Pain Catastrophising Scale (PCS)
Description
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.
Time Frame
Baseline and Six months
Title
Brief Fatigue Inventory (BFI)
Description
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.
Time Frame
Baseline and Six months
Title
Pain Self-Efficacy Questionnaire (PSEQ)
Description
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.
Time Frame
Baseline and Six months
Title
Survey of Pain Attitudes - Brief (SOPA-B)
Description
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.
Time Frame
Baseline and Six months
Title
Pain Coping Inventory (PC)
Description
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.
Time Frame
Baseline and Six months
Title
Short Form-36 Bodily Pain Scale (SF-36 BPS)
Description
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.
Time Frame
Baseline and Six months
Title
Pain and Sleep Questionnaire (PSQ)
Description
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.
Time Frame
Baseline and Six months
Title
Satisfaction with Life questionnaire (SWLS)
Description
5-item brief scale designed to measure a person's overall cognitive judgments about their satisfaction with life.
Time Frame
Baseline and Six months
Title
WHO-5 Well Being Index
Description
5 item scale designed to evaluate the subjective psychological well-being of the person.
Time Frame
Baseline and Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Fundación Eduardo Anitua
City
Vitoria
State/Province
Alava
ZIP/Postal Code
01007
Country
Spain
Facility Name
Instituto de Investigación y Formación en Ciencias Cognitivas - Nirakara
City
Madrid
State/Province
Colmenarejo
ZIP/Postal Code
28070
Country
Spain
Facility Name
Facultad de Psicología de la Universidad Complutense de Madrid.
City
Madrid
State/Province
Somosaguas
ZIP/Postal Code
28223
Country
Spain

12. IPD Sharing Statement

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Stress Reduction Program Based on Mindfulness for Patients With Discopathies

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