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

Primary Purpose

Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
MSC
CBT
Sponsored by
Instituto de Investigación Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pain focused on measuring Mindfulness, Self-Compassion, Chronic Pain, Psychological Intervention, Cognitive-Behavioural therapy, acceptance, catastrophising, Self-Care, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario La Paz.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness Self-Compassion Intervention MSC

Cognitive-Behavioural Intervention CBT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Self-Compassion
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

Acceptance
Chronic Pain Acceptance Questionnaire (CPAQ). 2 factors: Activity engagement and Pain willingness.
Acceptance
Chronic Pain Acceptance Questionnaire (CPAQ). 2 factors: Activity engagement and Pain willingness.
Acceptance
Chronic Pain Acceptance Questionnaire (CPAQ). 2 factors: Activity engagement and Pain willingness.
Pain Interference
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.
Pain Interference
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.
Pain Interference
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.
Pain Intensity
Analogical Visual Scale. From 0 to 10 scores.
Pain Intensity
Analogical Visual Scale. From 0 to 10 scores.
Pain Intensity
Analogical Visual Scale. From 0 to 10 scores.
Catastrophising
Pain Catastrophising Scale (PCS). Rumination, magnification of consequences and hopelessness. 13 items, self-administered.
Catastrophising
Pain Catastrophising Scale (PCS). Rumination, magnification of consequences and hopelessness. 13 items, self-administered.
Catastrophising
Pain Catastrophising Scale (PCS). Rumination, magnification of consequences and hopelessness. 13 items, self-administered.
Quality of life
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.
Quality of life
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.
Quality of life
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.
Anxiety and Depression
Levels of anxiety and depression. Symptomatology. Hospital Anxiety and Depression Scale (HADS). 14 items. 2 separated scores, 7 items each: anxiety and depression.
Anxiety and Depression
Levels of anxiety and depression. Symptomatology. Hospital Anxiety and Depression Scale (HADS). 14 items. 2 separated scores, 7 items each: anxiety and depression.
Anxiety and Depression
Levels of anxiety and depression. Symptomatology. Hospital Anxiety and Depression Scale (HADS). 14 items. 2 separated scores, 7 items each: anxiety and depression.
Satisfaction with the treatment
Satisfaction with the treatment (CRES-4). 4 questions. Scores from 0 to 300. The higher the punctuation, the higher satisfaction with treatment.
Adherence to the treatment
Adherence to the treatment (Number of sessions that one patient attends)
Self-Compassion
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.
Self-Compassion
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.

Full Information

First Posted
December 8, 2017
Last Updated
May 1, 2020
Sponsor
Instituto de Investigación Hospital Universitario La Paz
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1. Study Identification

Unique Protocol Identification Number
NCT03386422
Brief Title
Mindfulness Self-Compassion Intervention Versus a Cognitive-Behavioral Intervention to Improve Self-care in Chronic Pain
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"
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 3, 2017 (Actual)
Primary Completion Date
December 7, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Mindfulness, Self-Compassion, Chronic Pain, Psychological Intervention, Cognitive-Behavioural therapy, acceptance, catastrophising, Self-Care, Quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Self-Compassion Intervention MSC
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive-Behavioural Intervention CBT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MSC
Intervention Description
Mindfulness and Self-Compassion training
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
Cognitive-behavioural techniques training
Primary Outcome Measure Information:
Title
Self-Compassion
Description
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.
Time Frame
Up to 8 weeks
Secondary Outcome Measure Information:
Title
Acceptance
Description
Chronic Pain Acceptance Questionnaire (CPAQ). 2 factors: Activity engagement and Pain willingness.
Time Frame
Up to 8 weeks
Title
Acceptance
Description
Chronic Pain Acceptance Questionnaire (CPAQ). 2 factors: Activity engagement and Pain willingness.
Time Frame
In a 6 months follow-up
Title
Acceptance
Description
Chronic Pain Acceptance Questionnaire (CPAQ). 2 factors: Activity engagement and Pain willingness.
Time Frame
Day 1 of the intervention
Title
Pain Interference
Description
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.
Time Frame
Up to 8 weeks
Title
Pain Interference
Description
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.
Time Frame
In a 6 months follow-up
Title
Pain Interference
Description
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.
Time Frame
Day 1 of the intervention
Title
Pain Intensity
Description
Analogical Visual Scale. From 0 to 10 scores.
Time Frame
Up to 8 weeks.
Title
Pain Intensity
Description
Analogical Visual Scale. From 0 to 10 scores.
Time Frame
In a 6 months follow-up
Title
Pain Intensity
Description
Analogical Visual Scale. From 0 to 10 scores.
Time Frame
Day 1 of the intervention
Title
Catastrophising
Description
Pain Catastrophising Scale (PCS). Rumination, magnification of consequences and hopelessness. 13 items, self-administered.
Time Frame
Up to 8 weeks.
Title
Catastrophising
Description
Pain Catastrophising Scale (PCS). Rumination, magnification of consequences and hopelessness. 13 items, self-administered.
Time Frame
In a 6 months follow-up
Title
Catastrophising
Description
Pain Catastrophising Scale (PCS). Rumination, magnification of consequences and hopelessness. 13 items, self-administered.
Time Frame
Day 1 of the intervention
Title
Quality of life
Description
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.
Time Frame
Up to 8 weeks.
Title
Quality of life
Description
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.
Time Frame
In a 6 months follow-up
Title
Quality of life
Description
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.
Time Frame
Day 1 of the intervention
Title
Anxiety and Depression
Description
Levels of anxiety and depression. Symptomatology. Hospital Anxiety and Depression Scale (HADS). 14 items. 2 separated scores, 7 items each: anxiety and depression.
Time Frame
Up to 8 weeks.
Title
Anxiety and Depression
Description
Levels of anxiety and depression. Symptomatology. Hospital Anxiety and Depression Scale (HADS). 14 items. 2 separated scores, 7 items each: anxiety and depression.
Time Frame
In a 6 months follow-up
Title
Anxiety and Depression
Description
Levels of anxiety and depression. Symptomatology. Hospital Anxiety and Depression Scale (HADS). 14 items. 2 separated scores, 7 items each: anxiety and depression.
Time Frame
Day 1 of the intervention
Title
Satisfaction with the treatment
Description
Satisfaction with the treatment (CRES-4). 4 questions. Scores from 0 to 300. The higher the punctuation, the higher satisfaction with treatment.
Time Frame
Up to 8 weeks.
Title
Adherence to the treatment
Description
Adherence to the treatment (Number of sessions that one patient attends)
Time Frame
Up to 8 weeks.
Title
Self-Compassion
Description
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.
Time Frame
In a 6 months follow-up
Title
Self-Compassion
Description
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.
Time Frame
Day 1 of the intervention
Other Pre-specified Outcome Measures:
Title
Socio- demographic Data: Number of visited doctors.
Description
Number of visited doctors in the last 3 months. Sociodemographic data Questionnaire.
Time Frame
Day 1 of the intervention
Title
Socio- demographic Data: Number of visits to emergency units.
Description
Number of visits to emergency units in the last 3 months. Sociodemographic data Questionnaire.
Time Frame
Day 1 of the intervention
Title
Socio- demographic Data: course of pain expectation.
Description
Course of pain that the patient expects (improvement, same condition, progressive worsening…) at the moment the intervention starts. Socio-demographic data Questionnaire.
Time Frame
Day 1 of the intervention
Title
Socio- demographic Data: psychiatric history.
Description
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.
Time Frame
Day 1 of the intervention
Title
Socio- demographic Data: type of pain.
Description
Type of pain: area of pain in the body, diagnosis related to pain made for patient's doctor. Socio-demographic data Questionnaire.
Time Frame
Day 1 of the intervention
Title
Socio- demographic Data: time since pain started.
Description
Time since the pain started: amount of time the patient has lived with pain. Socio-demographic data Questionnaire.
Time Frame
Day 1 of the intervention
Title
Socio- demographic Data: job status.
Description
Job status: whether the patient is student, employed, unemployed, retired, or has a pension because of his/her disability. Socio-demographic data Questionnaire.
Time Frame
Day 1 of the intervention
Title
Socio- demographic Data: family life.
Description
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.
Time Frame
Day 1 of the intervention
Title
Socio- demographic Data: Marital Status
Description
Marital Status: whether the patient is single, married or in a couple, divorced, or widower. Socio-demographic data Questionnaire.
Time Frame
Day 1 of the intervention
Title
Socio- demographic Data: Gender
Description
Gender: Male or female. Socio-demographic data Questionnaire.
Time Frame
Day 1 of the intervention
Title
Socio- demographic Data: Age
Description
Age of the patient. Socio-demographic data Questionnaire.
Time Frame
Day 1 of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz Rodríguez Vega
Organizational Affiliation
Hospital Universitario La Paz. Universidad Autónoma de Madrid.
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario La Paz.
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

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

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