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NCT Number: NCT03386422

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

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario La Paz.

Madrid, 28046, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 related to the pain at the beginning of treatment, assessed by clinical interview and HADS (HADS-A or HADS-D > or = 8).
  • 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.

Treatment and study plan

MSC

Behavioral

Mindfulness and Self-Compassion training

CBT

Behavioral

Cognitive-behavioural techniques training

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Registry information

Official study 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"

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2017
Registry last updated
May 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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