Back PainNCT03911375

Stress Reduction Program Based on Mindfulness for Patients With Discopathies

A study testing Mindfulness Based Stress Reduction (MBSR) in people with Back Pain, run by Fundación Eduardo Anitua at 3 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Back Pain
What is being tested?: Mindfulness Based Stress Reduction (MBSR)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 3 sitesSpain
Study dates: 3 Apr 2019to 30 Mar 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

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

Other trials in Spain

About this study

Read the 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.

Conditions: Back Pain
Being tested: Mindfulness Based Stress Reduction (MBSR)
Medical subject headings: Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT03911375
Study group	Role	What they receive
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. Receives: Other: Mindfulness Based Stress Reduction (MBSR)
Control	No intervention	Participants assigned to the control group will follow the usual treatment, according to their diagnosis.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Baseline and Six months

Secondary outcomes (16)

Five Facet Mindfulness Questionnaire (FFMQ)
39 items scale that offers a total score of a person's level of mindfulness.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Six months
WHO-5 Well Being Index
5 item scale designed to evaluate the subjective psychological well-being of the person.
Measured: Baseline and Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 201930 Mar 2020

First posted11 Apr 2019
Study start3 Apr 2019
Primary completion30 Mar 2020
Study completion30 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03911375
Sponsor's protocol ID: FIBEA-01-EC/18/MIND
Status last verified: Jul 2021
First submitted: 2 Apr 2019
Last updated: 6 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Stress Reduction Program Based on Mindfulness for Patients With Discopathies
ClinicalTrials.gov ID: NCT03911375
Acronym / sponsor ID: FIBEA-01-EC/18/MIND
Conditions: Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Fundación Eduardo AnituaUniversity, hospital or other
Collaborators: Instituto de Investigación y Formación en Ciencias Cognitivas - Nirakara, Universidad Complutense de Madrid
Study start: 3 Apr 2019 (actual)
Primary completion: 30 Mar 2020 (actual)
Study completion: 30 Mar 2020 (actual)
First posted: 11 Apr 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Mindfulness Based Stress Reduction (MBSR)	Experimental	Other: 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.
Control	No intervention	–Participants assigned to the control group will follow the usual treatment, according to their diagnosis.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

Serious psychopathologies
Suicidal thoughts.
Deep depression
Psychosis
Drug addiction

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Other	Mindfulness Based Stress Reduction (MBSR)

Primary outcome

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.
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.
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.

16 secondary outcomes

Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Baseline and Six months
Self-Compassion Scale (SCS)
Time frame: Baseline and Six months
Perceived Stress Scale (PSS)
Time frame: Baseline and Six months
DASS-21
Time frame: Baseline and Six months
Chronic Pain Grade Scale (CPGS; 90)
Time frame: Baseline and Six months
Brief Pain Inventory (BPI)
Time frame: Baseline and Six months
Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)
Time frame: Baseline and Six months
Pain Catastrophising Scale (PCS)
Time frame: Baseline and Six months
Brief Fatigue Inventory (BFI)
Time frame: Baseline and Six months
Pain Self-Eﬃcacy Questionnaire (PSEQ)
Time frame: Baseline and Six months
Survey of Pain Attitudes - Brief (SOPA-B)
Time frame: Baseline and Six months
Pain Coping Inventory (PC)
Time frame: Baseline and Six months
Short Form-36 Bodily Pain Scale (SF-36 BPS)
Time frame: Baseline and Six months
Pain and Sleep Questionnaire (PSQ)
Time frame: Baseline and Six months
Satisfaction with Life questionnaire (SWLS)
Time frame: Baseline and Six months
WHO-5 Well Being Index
Time frame: Baseline and Six months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.

Related trials for Back Pain

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Recruiting
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Based Stress Reduction (MBSR) in people with Back Pain, run by Fundación Eduardo Anitua at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stress change (time frame: Baseline and Six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03911375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.