Stress Reduction Program Based on Mindfulness for Patients With Discopathies

NCT ID: NCT03911375

Last Updated: 2022-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-03

Study Completion Date

2020-03-30

Brief Summary

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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

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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

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Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness Based Stress Reduction (MBSR)

Intervention Type 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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Investigación y Formación en Ciencias Cognitivas - Nirakara

UNKNOWN

Sponsor Role collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role collaborator

Fundación Eduardo Anitua

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fundación Eduardo Anitua

Vitoria-Gasteiz, Alava, Spain

Site Status

Instituto de Investigación y Formación en Ciencias Cognitivas - Nirakara

Madrid, Colmenarejo, Spain

Site Status

Facultad de Psicología de la Universidad Complutense de Madrid.

Madrid, Somosaguas, Spain

Site Status

Countries

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Spain

Other Identifiers

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FIBEA-01-EC/18/MIND

Identifier Type: -

Identifier Source: org_study_id

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