Ignite Creation Date:
2024-05-06 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03386422
Status:
COMPLETED
Last Update Posted:
2020-05-05
First Post:
2017-12-08
Brief Title:
Mindfulness Self-Compassion Intervention Versus a Cognitive-Behavioral Intervention to Improve Self-care in Chronic Pain
Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Organization:
Instituto de Investigación Hospital Universitario La Paz
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 investigators 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
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 investigators 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
Investigators 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
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
Investigators 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None