Clinical trial NCT03386422: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Keywords: Mindfulness
Self-Compassion
Chronic Pain
Psychological Intervention
Cognitive-Behavioural therapy
acceptance
catastrophising
Self-Care
Quality of life
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Self-Compassion
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Acceptance
timeFrame: Up to 8 weeks
measure: Acceptance
timeFrame: In a 6 months follow-up
measure: Acceptance
timeFrame: Day 1 of the intervention
measure: Pain Interference
timeFrame: Up to 8 weeks
measure: Pain Interference
timeFrame: In a 6 months follow-up
measure: Pain Interference
timeFrame: Day 1 of the intervention
measure: Pain Intensity
timeFrame: Up to 8 weeks.
measure: Pain Intensity
timeFrame: In a 6 months follow-up
measure: Pain Intensity
timeFrame: Day 1 of the intervention
measure: Catastrophising
timeFrame: Up to 8 weeks.
measure: Catastrophising
timeFrame: In a 6 months follow-up
measure: Catastrophising
timeFrame: Day 1 of the intervention
measure: Quality of life
timeFrame: Up to 8 weeks.
measure: Quality of life
timeFrame: In a 6 months follow-up
measure: Quality of life
timeFrame: Day 1 of the intervention
measure: Anxiety and Depression
timeFrame: Up to 8 weeks.
measure: Anxiety and Depression
timeFrame: In a 6 months follow-up
measure: Anxiety and Depression
timeFrame: Day 1 of the intervention
measure: Satisfaction with the treatment
timeFrame: Up to 8 weeks.
measure: Adherence to the treatment
timeFrame: Up to 8 weeks.
measure: Self-Compassion
timeFrame: In a 6 months follow-up
measure: Self-Compassion
timeFrame: Day 1 of the intervention
Other outcomes:
measure: Socio- demographic Data: Number of visited doctors.
timeFrame: Day 1 of the intervention
measure: Socio- demographic Data: Number of visits to emergency units.
timeFrame: Day 1 of the intervention
measure: Socio- demographic Data: course of pain expectation.
timeFrame: Day 1 of the intervention
measure: Socio- demographic Data: psychiatric history.
timeFrame: Day 1 of the intervention
measure: Socio- demographic Data: type of pain.
timeFrame: Day 1 of the intervention
measure: Socio- demographic Data: time since pain started.
timeFrame: Day 1 of the intervention
measure: Socio- demographic Data: job status.
timeFrame: Day 1 of the intervention
measure: Socio- demographic Data: family life.
timeFrame: Day 1 of the intervention
measure: Socio- demographic Data: Marital Status
timeFrame: Day 1 of the intervention
measure: Socio- demographic Data: Gender
timeFrame: Day 1 of the intervention
measure: Socio- demographic Data: Age
timeFrame: Day 1 of the intervention
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz.
Study officials:
affiliation: Hospital Universitario La Paz. Universidad Autónoma de Madrid.
name: Beatriz Rodríguez Vega
role: STUDY_DIRECTOR
References: