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

Chronic Pain Clinical Trial

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03386422
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: February 3, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: May 2020
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: December 30, 2018
• Est. primary completion date: December 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• MSC
Mindfulness and Self-Compassion training
• CBT
Cognitive-behavioural techniques training

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz.	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Socio- demographic Data: Number of visited doctors.	Number of visited doctors in the last 3 months. Sociodemographic data Questionnaire.	Day 1 of the intervention
Other	Socio- demographic Data: Number of visits to emergency units.	Number of visits to emergency units in the last 3 months. Sociodemographic data Questionnaire.	Day 1 of the intervention
Other	Socio- demographic Data: course of pain expectation.	Course of pain that the patient expects (improvement, same condition, progressive worsening…) at the moment the intervention starts. Socio-demographic data Questionnaire.	Day 1 of the intervention
Other	Socio- demographic Data: psychiatric history.	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.	Day 1 of the intervention
Other	Socio- demographic Data: type of pain.	Type of pain: area of pain in the body, diagnosis related to pain made for patient's doctor. Socio-demographic data Questionnaire.	Day 1 of the intervention
Other	Socio- demographic Data: time since pain started.	Time since the pain started: amount of time the patient has lived with pain. Socio-demographic data Questionnaire.	Day 1 of the intervention
Other	Socio- demographic Data: job status.	Job status: whether the patient is student, employed, unemployed, retired, or has a pension because of his/her disability. Socio-demographic data Questionnaire.	Day 1 of the intervention
Other	Socio- demographic Data: family life.	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.	Day 1 of the intervention
Other	Socio- demographic Data: Marital Status	Marital Status: whether the patient is single, married or in a couple, divorced, or widower. Socio-demographic data Questionnaire.	Day 1 of the intervention
Other	Socio- demographic Data: Gender	Gender: Male or female. Socio-demographic data Questionnaire.	Day 1 of the intervention
Other	Socio- demographic Data: Age	Age of the patient. Socio-demographic data Questionnaire.	Day 1 of the intervention
Primary	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.	Up to 8 weeks
Secondary	Acceptance	Chronic Pain Acceptance Questionnaire (CPAQ). 2 factors: Activity engagement and Pain willingness.	Up to 8 weeks
Secondary	Acceptance	Chronic Pain Acceptance Questionnaire (CPAQ). 2 factors: Activity engagement and Pain willingness.	In a 6 months follow-up
Secondary	Acceptance	Chronic Pain Acceptance Questionnaire (CPAQ). 2 factors: Activity engagement and Pain willingness.	Day 1 of the intervention
Secondary	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.	Up to 8 weeks
Secondary	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.	In a 6 months follow-up
Secondary	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.	Day 1 of the intervention
Secondary	Pain Intensity	Analogical Visual Scale. From 0 to 10 scores.	Up to 8 weeks.
Secondary	Pain Intensity	Analogical Visual Scale. From 0 to 10 scores.	In a 6 months follow-up
Secondary	Pain Intensity	Analogical Visual Scale. From 0 to 10 scores.	Day 1 of the intervention
Secondary	Catastrophising	Pain Catastrophising Scale (PCS). Rumination, magnification of consequences and hopelessness. 13 items, self-administered.	Up to 8 weeks.
Secondary	Catastrophising	Pain Catastrophising Scale (PCS). Rumination, magnification of consequences and hopelessness. 13 items, self-administered.	In a 6 months follow-up
Secondary	Catastrophising	Pain Catastrophising Scale (PCS). Rumination, magnification of consequences and hopelessness. 13 items, self-administered.	Day 1 of the intervention
Secondary	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.	Up to 8 weeks.
Secondary	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.	In a 6 months follow-up
Secondary	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.	Day 1 of the intervention
Secondary	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.	Up to 8 weeks.
Secondary	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.	In a 6 months follow-up
Secondary	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.	Day 1 of the intervention
Secondary	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.	Up to 8 weeks.
Secondary	Adherence to the treatment	Adherence to the treatment (Number of sessions that one patient attends)	Up to 8 weeks.
Secondary	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.	In a 6 months follow-up
Secondary	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.	Day 1 of the intervention