Clinical trial NCT03911375: 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
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Lead sponsor: Fundación Eduardo Anitua
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación y Formación en Ciencias Cognitivas - Nirakara
name: Universidad Complutense de Madrid
First posted: 2019-04-11
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Stress change
timeFrame: Baseline and Six months
measure: Variation of cytokines
timeFrame: Baseline and Six months
measure: Variation of the nocturnal apnea index.
timeFrame: Baseline and Six months
Secondary outcomes:
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline and Six months
measure: Self-Compassion Scale (SCS)
timeFrame: Baseline and Six months
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline and Six months
measure: DASS-21
timeFrame: Baseline and Six months
measure: Chronic Pain Grade Scale (CPGS; 90)
timeFrame: Baseline and Six months
measure: Brief Pain Inventory (BPI)
timeFrame: Baseline and Six months
measure: Chronic Pain Acceptance Questionnaire-Revised (CPAQ-R)
timeFrame: Baseline and Six months
measure: Pain Catastrophising Scale (PCS)
timeFrame: Baseline and Six months
measure: Brief Fatigue Inventory (BFI)
timeFrame: Baseline and Six months
measure: Pain Self-Eﬃcacy Questionnaire (PSEQ)
timeFrame: Baseline and Six months
measure: Survey of Pain Attitudes - Brief (SOPA-B)
timeFrame: Baseline and Six months
measure: Pain Coping Inventory (PC)
timeFrame: Baseline and Six months
measure: Short Form-36 Bodily Pain Scale (SF-36 BPS)
timeFrame: Baseline and Six months
measure: Pain and Sleep Questionnaire (PSQ)
timeFrame: Baseline and Six months
measure: Satisfaction with Life questionnaire (SWLS)
timeFrame: Baseline and Six months
measure: WHO-5 Well Being Index
timeFrame: Baseline and Six months
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Fundación Eduardo Anitua
state: Alava
city: Madrid
country: Spain
facility: Instituto de Investigación y Formación en Ciencias Cognitivas - Nirakara
state: Colmenarejo
city: Madrid
country: Spain
facility: Facultad de Psicología de la Universidad Complutense de Madrid.
state: Somosaguas
Study officials:
References: