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Mindfulness Self-Compassion Intervention Versus a Cognitive-Behavioral Intervention to Improve Self-care in Chronic Pain

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ClinicalTrials.gov Identifier: NCT03386422
Recruitment Status : Active, not recruiting
First Posted : December 29, 2017
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Angela Palao, Instituto de Investigación Hospital Universitario La Paz

Brief Summary:

Approximately 10-23% of people suffer from chronic pain in our country. Chronic pain is associated with emotional distress (anxiety and depression), physical and social impairment and reduction of quality of life in patients who suffer from this condition.

Self-Compassion is a useful attitude in order to regulate emotions, to be able to accept the experience that one is going through and to improve self-care in general population. Cognitive-behavioral programs (CBT) have already demonstrated that they are effective in order to reduce catastrophizing and passive coping with pain. However, effects of Mindful Self-Compassion interventions (based on mindfulness skills but not only) on chronic pain condition are still unknown.

The investigator's principal hypothesis is: MSC program will be, at least, as effective as CBT program in order to improve quality of life, self-compassion, self-care and acceptance capacity; and as effective as CBT to reduce catastrophizing, anxiety and depression in a chronic pain patients sample.

Moreover, investigators also hypothesize that MSC program will be, at least, as effective as CBT program in order to maintain the achieved benefits in a 6 months follow-up.

Investigators will conduct a Randomized Controlled Trial with two treatment arms in a chronic pain sample of patients of Hospital Universitario La Paz, Madrid.

After all recollection of data is done, investigators will conduct statistic analysis in order to accept or refuse our hypothesis.


Condition or disease Intervention/treatment Phase
Chronic Pain Behavioral: MSC Behavioral: CBT Not Applicable

Detailed Description:

Approximately 10-23% of people suffer from chronic pain in our country. Chronic pain is associated with emotional distress (anxiety and depression), physical and social impairment and reduction of quality of life in patients who suffer from this condition.

Recent studies have elucidated that some conditions are clearly correlated with chronic pain, and could explain emotional distress and impairment in these patients. Such conditions are: attention bias to pain, cognitive inflexibility, fear avoidance, catastrophizing, passive coping with pain and no acceptance.

Recent meta-analysis suggest that Mindfulness-based interventions reduce anxiety and pain interference in daily life in patients with chronic pain. They do so through mechanisms that improve capacity of acceptance (whatever the experience is) and reduce catastrophizing. Self-Compassion is a useful attitude in order to regulate emotions, to be able to accept the experience that one is going through and to improve self-care in general population. Cognitive-behavioral programs (CBT) have already demonstrated that they are effective in order to reduce catastrophizing and passive coping with pain. However, effects of Mindful Self-Compassion interventions (based on mindfulness skills but not only) on chronic pain condition are still unknown.

Neff and Germer have developed a specific program to enhance self-compassion named Mindful Self-Compassion (MSC) that could be helpful to people with clinical problems. In spite of promising results of this interventions based on acceptation and self-compassion, its effectiveness on chronic pain conditions remains still unclear.

Investigator's principal hypothesis is: MSC program will be, at least, as effective as CBT program in order to improve quality of life, self-compassion, self-care and acceptance capacity; and as effective as CBT to reduce catastrophizing, anxiety and depression in a chronic pain patients sample.

Moreover, investigators also hypothesize that MSC program will be, at least, as effective as CBT program in order to maintain the achieved benefits in a 6 months follow-up.

Investigators will conduct a Randomized Controlled Trial with two treatment arms in a chronic pain sample of patients of Hospital Universitario La Paz, Madrid.

Both interventions will have 8 sessions, weekly frequency, duration of 2 hours and a half per session, and both programs will be conducted by clinical experts.

Investigators will asses levels of anxiety, depression, catastrophizing, pain interference, pain intensity, self-compassion and quality of life at the beginning of the intervention, at the end of the intervention, and a 6 months follow-up. Investigators also will administer a socio-demographic questionnaire at the beginning of the intervention to collect data about age, gender and pain characteristics.

After all recollection of data is done, investigators will conduct statistic analysis in order to accept or refuse their hypothesis.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: "Pilot Study to Compare the Effectiveness of a Mindfulness Self-Compassion Intervention Versus a Cognitive-Behavioural Intervention to Improve Self-care and Quality of Life in a Chronic Pain Sample"
Actual Study Start Date : February 3, 2017
Actual Primary Completion Date : December 7, 2017
Estimated Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Mindfulness Self-Compassion Intervention MSC

Mindfulness Self-Compassion (MSC) is a standardized program to increase self-compassion. It has been developed by Neff and Germer. The structure of the program is similar to de Mindfulness-Based Stress Reduction program (MBSR), with duration of sessions between 2 and 2 hours and a half. The frequency of the sessions is one per week for 8 weeks, with practical and experiential exercices in sessions and between sessions.

The MSC program focuses primary on helping patients to develop self-compassion, and it includes Mindfulness just as a secondary component.

The MSC program will be conducted by a clinician trained in this specific program.

Behavioral: MSC
Mindfulness and Self-Compassion training

Active Comparator: Cognitive-Behavioural Intervention CBT

It has been adapted a Cognitive-Behavioural Intervention for Chronic Pain by Moix and Kovacs. Our program will have 8 sessions, with duration of sessions between 2 and 2 hours and a half. The frequency of the sessions is one per week for 8 weeks, with homework between sessions.

During these 8 sessions we will train the following techniques: psychoeducation about pain, relaxation training, cognitive restructuring training, solving problem training, psychoeducation about emotions, interpersonal skills and time organization.

Behavioral: CBT
Cognitive-behavioural techniques training




Primary Outcome Measures :
  1. Self-Compassion [ Time Frame: Up to 8 weeks ]
    Self-Compassion Scale (SCS, long version). Self-compassion and Self-care. Self-kindness, Common Humanity and Mindfulness. 26 items. Total score and 3 sub-scores from 1 to 5. Likert scale from 1 to 5.


Secondary Outcome Measures :
  1. Acceptance [ Time Frame: Up to 8 weeks ]
    Chronic Pain Acceptance Questionnaire (CPAQ). 2 factors: Activity engagement and Pain willingness.

  2. Acceptance [ Time Frame: In a 6 months follow-up ]
    Chronic Pain Acceptance Questionnaire (CPAQ). 2 factors: Activity engagement and Pain willingness.

  3. Acceptance [ Time Frame: Day 1 of the intervention ]
    Chronic Pain Acceptance Questionnaire (CPAQ). 2 factors: Activity engagement and Pain willingness.

  4. Pain Interference [ Time Frame: Up to 8 weeks ]
    Pain interference in daily life. Brief Pain Inventory (BPI): pain intensity and impact of pain in daily life. Investigators will use Impact in daily life sub-scale (7 items). Scores are from 0 to10.

  5. Pain Interference [ Time Frame: In a 6 months follow-up ]
    Pain interference in daily life. Brief Pain Inventory (BPI): pain intensity and impact of pain in daily life. Investigators will use Impact in daily life sub-scale (7 items). Scores are from 0 to10.

  6. Pain Interference [ Time Frame: Day 1 of the intervention ]
    Pain interference in daily life. Brief Pain Inventory (BPI): pain intensity and impact of pain in daily life. Investigators will use Impact in daily life sub-scale (7 items). Scores are from 0 to10.

  7. Pain Intensity [ Time Frame: Up to 8 weeks. ]
    Analogical Visual Scale. From 0 to 10 scores.

  8. Pain Intensity [ Time Frame: In a 6 months follow-up ]
    Analogical Visual Scale. From 0 to 10 scores.

  9. Pain Intensity [ Time Frame: Day 1 of the intervention ]
    Analogical Visual Scale. From 0 to 10 scores.

  10. Catastrophising [ Time Frame: Up to 8 weeks. ]
    Pain Catastrophising Scale (PCS). Rumination, magnification of consequences and hopelessness. 13 items, self-administered.

  11. Catastrophising [ Time Frame: In a 6 months follow-up ]
    Pain Catastrophising Scale (PCS). Rumination, magnification of consequences and hopelessness. 13 items, self-administered.

  12. Catastrophising [ Time Frame: Day 1 of the intervention ]
    Pain Catastrophising Scale (PCS). Rumination, magnification of consequences and hopelessness. 13 items, self-administered.

  13. Quality of life [ Time Frame: Up to 8 weeks. ]
    Health-Related Quality Of Life, Short Form (SF-36). 36 items. 8 sub-scores, no total score. Physical function, physical role, body pain, general state of health, vitality, social function, emotional role and mental health.

  14. Quality of life [ Time Frame: In a 6 months follow-up ]
    Health-Related Quality Of Life, Short Form (SF-36). 36 items. 8 sub-scores, no total score. Physical function, physical role, body pain, general state of health, vitality, social function, emotional role and mental health.

  15. Quality of life [ Time Frame: Day 1 of the intervention ]
    Health-Related Quality Of Life, Short Form (SF-36). 36 items. 8 sub-scores, no total score. Physical function, physical role, body pain, general state of health, vitality, social function, emotional role and mental health.

  16. Anxiety and Depression [ Time Frame: Up to 8 weeks. ]
    Levels of anxiety and depression. Symptomatology. Hospital Anxiety and Depression Scale (HADS). 14 items. 2 separated scores, 7 items each: anxiety and depression.

  17. Anxiety and Depression [ Time Frame: In a 6 months follow-up ]
    Levels of anxiety and depression. Symptomatology. Hospital Anxiety and Depression Scale (HADS). 14 items. 2 separated scores, 7 items each: anxiety and depression.

  18. Anxiety and Depression [ Time Frame: Day 1 of the intervention ]
    Levels of anxiety and depression. Symptomatology. Hospital Anxiety and Depression Scale (HADS). 14 items. 2 separated scores, 7 items each: anxiety and depression.

  19. Satisfaction with the treatment [ Time Frame: Up to 8 weeks. ]
    Satisfaction with the treatment (CRES-4). 4 questions. Scores from 0 to 300. The higher the punctuation, the higher satisfaction with treatment.

  20. Adherence to the treatment [ Time Frame: Up to 8 weeks. ]
    Adherence to the treatment (Number of sessions that one patient attends)

  21. Self-Compassion [ Time Frame: In a 6 months follow-up ]
    Self-Compassion Scale (SCS, long version). Self-compassion and Self-care. Self-kindness, Common Humanity and Mindfulness. 26 items. Total score and 3 sub-scores from 1 to 5. Likert scale from 1 to 5.

  22. Self-Compassion [ Time Frame: Day 1 of the intervention ]
    Self-Compassion Scale (SCS, long version). Self-compassion and Self-care. Self-kindness, Common Humanity and Mindfulness. 26 items. Total score and 3 sub-scores from 1 to 5. Likert scale from 1 to 5.


Other Outcome Measures:
  1. Socio- demographic Data: Number of visited doctors. [ Time Frame: Day 1 of the intervention ]
    Number of visited doctors in the last 3 months. Sociodemographic data Questionnaire.

  2. Socio- demographic Data: Number of visits to emergency units. [ Time Frame: Day 1 of the intervention ]
    Number of visits to emergency units in the last 3 months. Sociodemographic data Questionnaire.

  3. Socio- demographic Data: course of pain expectation. [ Time Frame: Day 1 of the intervention ]
    Course of pain that the patient expects (improvement, same condition, progressive worsening…) at the moment the intervention starts. Socio-demographic data Questionnaire.

  4. Socio- demographic Data: psychiatric history. [ Time Frame: Day 1 of the intervention ]
    Psychiatric history: whether the patient has or has not a history of mental health services visits for some kind of mental disorder. Socio-demographic data questionnaire.

  5. Socio- demographic Data: type of pain. [ Time Frame: Day 1 of the intervention ]
    Type of pain: area of pain in the body, diagnosis related to pain made for patient's doctor. Socio-demographic data Questionnaire.

  6. Socio- demographic Data: time since pain started. [ Time Frame: Day 1 of the intervention ]
    Time since the pain started: amount of time the patient has lived with pain. Socio-demographic data Questionnaire.

  7. Socio- demographic Data: job status. [ Time Frame: Day 1 of the intervention ]
    Job status: whether the patient is student, employed, unemployed, retired, or has a pension because of his/her disability. Socio-demographic data Questionnaire.

  8. Socio- demographic Data: family life. [ Time Frame: Day 1 of the intervention ]
    Family life: It is asked with whom the patient lives (couple, alone, kids, kids and couple…), if he/she has kids and if he/she lives with them. Socio-demographic data Questionnaire.

  9. Socio- demographic Data: Marital Status [ Time Frame: Day 1 of the intervention ]
    Marital Status: whether the patient is single, married or in a couple, divorced, or widower. Socio-demographic data Questionnaire.

  10. Socio- demographic Data: Gender [ Time Frame: Day 1 of the intervention ]
    Gender: Male or female. Socio-demographic data Questionnaire.

  11. Socio- demographic Data: Age [ Time Frame: Day 1 of the intervention ]
    Age of the patient. Socio-demographic data Questionnaire.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Older than 18 years old.
  • Being in treatment in the Chronic Pain Unit at Hospital Universitario La Paz because of having a chronic pain of more than 3 months of duration, no matter the aetiology.
  • Capable of understanding and giving his or her written informed consent.
  • Significant levels of distress and disability related to the pain at the beginning of treatment, assessed by clinical interview and HADS (> or = 8).
  • Significant levels of pain interference in daily life assessed by sub-scale of interference of the Brief Pain Inventory (> or = 5).
  • Significant levels of "catastrophising" at the beginning of the treatment assessed by Pain Catastrophizing Scale (PCS) (> or = 30).
  • Patients that meet criteria for Mixed Adaptive Disorder, mild to moderate Depressive Disorder or Dysthymia, assessed by clinical interview conducted by a psychiatry of the Chronic Pain Unit or Mental Health Center.

Exclusion Criteria:

  • Intelectual disability or cognitive impairment or dementia.
  • Insufficient knowledge of the language to understand and participate on the intervention program.
  • Serious mental illness in acute state at the moment of the beginning of the intervention.
  • Substance abuse in the last 6 months.
  • Autolytic ideas at the moment of the assessment.
  • Previous training in mindfulness or CBT techniques.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386422


Locations
Spain
Hospital Universitario La Paz.
Madrid, Spain, 28046
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Investigators
Study Director: Beatriz Rodríguez Vega Hospital Universitario La Paz. Universidad Autónoma de Madrid.
  Study Documents (Full-Text)

Documents provided by Angela Palao, Instituto de Investigación Hospital Universitario La Paz:

Responsible Party: Angela Palao, Psychiatry. PhD., Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT03386422     History of Changes
Other Study ID Numbers: 1
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Angela Palao, Instituto de Investigación Hospital Universitario La Paz:
Mindfulness
Self-Compassion
Chronic Pain
Psychological Intervention
Cognitive-Behavioural therapy
acceptance
catastrophising
Self-Care
Quality of life

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms