Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106275
Status:
UNKNOWN
Last Update Posted:
2006-01-31
First Post:
2005-03-21
Brief Title:
Mindfulness-Based Stress Reduction Program as an Intervention in Patients With Fibromyalgia
Sponsor:
University Hospital Freiburg
Organization:
University Hospital Freiburg
Study Overview
Official Title:
Mindfulness-Based Stress Reduction Program as an Intervention in Patients With Fibromyalgia A Three-Armed Randomized Clinical Study
Status:
UNKNOWN
Status Verified Date:
2005-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Fibromyalgia is a clinical syndrome with chronic pain fatigue and sleep disorders being the main symptoms There is no commonly accepted efficacious treatment modality Training in mindfulness-based stress reduction MBSR is a structured 8-week cognitively and affectively oriented intervention program and has been shown to produce health benefits in a number of studies
We plan to conduct a randomized controlled clinical study with the aim of testing the efficacy of MBSR for fibromyalgia Because fibromyalgia is almost exclusively a female disorder we will limit this investigation to women 180 female fibromyalgia patients will be randomized into three groups
1 Mindfulness training
2 Active control
3 Wait-list control
The main outcome criteria are self-reported and fibromyalgia-specific Quality of Life QOL and a Biobehavioral Fibromyalgia Index composed of a variety of psychophysiological and behavioral variables This index will be generated from data gathered via an ambulatory psychophysiological monitoring system which comprises parameters of mobility sleep quality and cardiovascular well-being These and other relevant variables depression score general QOL pain quality anxiety mindfulness compliance other therapeutic measures will be assessed at the beginning and end of the training as well as at 4- and 12-months post-treatment A primary focus will be assessing whether it is possible to promote psychological well-being through the learning of attentive presence and any resultant affective affirmation
We plan to conduct a randomized controlled clinical study with the aim of testing the efficacy of MBSR for fibromyalgia Because fibromyalgia is almost exclusively a female disorder we will limit this investigation to women 180 female fibromyalgia patients will be randomized into three groups
1 Mindfulness training
2 Active control
3 Wait-list control
The main outcome criteria are self-reported and fibromyalgia-specific Quality of Life QOL and a Biobehavioral Fibromyalgia Index composed of a variety of psychophysiological and behavioral variables This index will be generated from data gathered via an ambulatory psychophysiological monitoring system which comprises parameters of mobility sleep quality and cardiovascular well-being These and other relevant variables depression score general QOL pain quality anxiety mindfulness compliance other therapeutic measures will be assessed at the beginning and end of the training as well as at 4- and 12-months post-treatment A primary focus will be assessing whether it is possible to promote psychological well-being through the learning of attentive presence and any resultant affective affirmation
Detailed Description:
Background
Fibromyalgia is a clinical syndrome with chronic pain fatigue and sleep disorders being the main symptoms There is no commonly accepted efficacious treatment modality Training in mindfulness meditation or mindfulness-based stress reductionMBSR is based on procedures derived from Buddhist insight meditation and developed into an eight-week structured program by Kabat-Zinn eg 1982 Gen Hosp Psychiat 433-47 However although mindfulness meditation derives from Buddhist practices the procedures are completely nonesoteric and nonsectarian In essence it may be largely characterized in terms of a cognitively and affectively oriented intervention program and has been shown to produce health benefits in a number of pilot studies uncontrolled observational studies and randomized investigations Promising pilot data are also available for fibromyalgia patients In a meta-analysis conducted by the PI principal investigator clinically important and statistically significant health benefits were found across individuals with a wide range of conditions
Hypotheses
1 A mindfulness-based stress reduction program MBSR is effective in improving the quality of life psychological well-being and diminishing fibromyalgia-related symptoms in chronically ill patients
2 the mindfulness component of the MBSR a spiritual-based method allows the patient to receive the energy of love which is then transformative 3 the effects of the mindfulness training will be visible in physiologic measurements including autonomic nervous system activity
Method and Results
This is a randomized controlled clinical study with the aim of testing the efficacy of an MBSR for fibromyalgia Because fibromyalgia is almost exclusively a female disorder the investigation is limited to 180 female fibromyalgia patients who will be randomized into three groups Mindfulness training Active control and Wait-list Control
The main outcome criteria are self-reported and fibromyalgia-specific Quality of Life and a Biobehavioral Fibromyalgia Index composed of a variety of psychophysiological and behavioral variables This index will be generated from data parameters of mobility sleep quality and cardiovascular well-being These and other relevant variables depression score general QOL pain quality anxiety mindfulness compliance and other therapeutic measures will be assessed at the beginning and end of the training as well as at 4- and 12-months post-treatment A primary focus will be assessing whether it is possible to promote psychological well-being through the learning of attentive presence and any resultant affective affirmation
Anticipated Results
MBSR will be proven to be a reliable and efficacious treatment for fibromyalgia as reflected in an improvement in patient reported health variables It is also expected that a better understanding of the autonomic nervous system in the process of generating and maintaining fibromyalgia will be achieved
Fibromyalgia is a clinical syndrome with chronic pain fatigue and sleep disorders being the main symptoms There is no commonly accepted efficacious treatment modality Training in mindfulness meditation or mindfulness-based stress reductionMBSR is based on procedures derived from Buddhist insight meditation and developed into an eight-week structured program by Kabat-Zinn eg 1982 Gen Hosp Psychiat 433-47 However although mindfulness meditation derives from Buddhist practices the procedures are completely nonesoteric and nonsectarian In essence it may be largely characterized in terms of a cognitively and affectively oriented intervention program and has been shown to produce health benefits in a number of pilot studies uncontrolled observational studies and randomized investigations Promising pilot data are also available for fibromyalgia patients In a meta-analysis conducted by the PI principal investigator clinically important and statistically significant health benefits were found across individuals with a wide range of conditions
Hypotheses
1 A mindfulness-based stress reduction program MBSR is effective in improving the quality of life psychological well-being and diminishing fibromyalgia-related symptoms in chronically ill patients
2 the mindfulness component of the MBSR a spiritual-based method allows the patient to receive the energy of love which is then transformative 3 the effects of the mindfulness training will be visible in physiologic measurements including autonomic nervous system activity
Method and Results
This is a randomized controlled clinical study with the aim of testing the efficacy of an MBSR for fibromyalgia Because fibromyalgia is almost exclusively a female disorder the investigation is limited to 180 female fibromyalgia patients who will be randomized into three groups Mindfulness training Active control and Wait-list Control
The main outcome criteria are self-reported and fibromyalgia-specific Quality of Life and a Biobehavioral Fibromyalgia Index composed of a variety of psychophysiological and behavioral variables This index will be generated from data parameters of mobility sleep quality and cardiovascular well-being These and other relevant variables depression score general QOL pain quality anxiety mindfulness compliance and other therapeutic measures will be assessed at the beginning and end of the training as well as at 4- and 12-months post-treatment A primary focus will be assessing whether it is possible to promote psychological well-being through the learning of attentive presence and any resultant affective affirmation
Anticipated Results
MBSR will be proven to be a reliable and efficacious treatment for fibromyalgia as reflected in an improvement in patient reported health variables It is also expected that a better understanding of the autonomic nervous system in the process of generating and maintaining fibromyalgia will be achieved
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None