Stress Reduction Program Based on Mindfulness for Patients With Discopathies

Fundación Eduardo Anitua

Status: Completed

Conditions: Back Pain

Treatments: Other: Mindfulness Based Stress Reduction (MBSR)

Study type: Interventional

Funder types: Other

Identifiers

NCT03911375

FIBEA-01-EC/18/MIND

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 2 patient groups

Mindfulness Based Stress Reduction (MBSR)

Experimental group

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.

Treatment:

Other: Mindfulness Based Stress Reduction (MBSR)

Control

No Intervention group

Description:

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