Ignite Creation Date:
2024-05-06 @ 2:51 AM
Last Modification Date:
2024-10-26 @ 11:24 AM
Study NCT ID:
NCT02147483
Status:
COMPLETED
Last Update Posted:
2019-04-17
First Post:
2013-11-14
Brief Title:
Mindfulness-Based Relapse Prevention for Alcohol Use Disorders in Remission
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Mindfulness-Based Relapse Prevention and Stress Reactivity in Alcohol Dependent Individuals A Pilot Study
Status:
COMPLETED
Status Verified Date:
2019-04
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:
MBRP
Brief Summary:
We propose to conduct a pilot study that will examine the utility and mechanisms of Mindfulness-Based Relapse Prevention in reducing alcohol consumption relapse rates and physiological arousal to stress in adults 21 years of age and older who have met DSM-IV-TR diagnostic criteria for alcohol dependence within the past year but have abstained from drinking for the last thirty days MBRP is designed to improve ones ability to self-regulate emotions thoughts and physical states thus reducing the need to alleviate associated discomfort through substance use Participants assigned to the intervention group will receive an 8-week training course of MBRP over a period of nine weeks participants assigned to the Treatment As Usual TAU group will continue treatment as usual which includes utilizing their own effective strategies to refrain from alcohol use All participants will be assessed for pretreatment severity of psychological abusetrauma as well as pre and posttreatment psychosocial functioning eg alcohol consumption symptoms of depression and anxiety emotion regulationcoping The outcome of treatment will be evaluated using a Timeline Followback drinking data and b self-report ratings of acquisition of MBRP skills eg statetrait mindfulness acceptance and awareness and perceived stress and depressive and anxiety symptom severity We hypothesize that participants who receive MBRP training will demonstrate greater acceptance and awareness reduced cravings and have a lower likelihood of relapse than participants in the TAU group It is also expected that MBRP participants will demonstrate greater improvements on psychological measures of depression anxiety emotion regulation and coping and show less perceived stress and physiological arousal to stress compared to TAU participants Finally little is known about which types of individuals are most likely to benefit from MBRP Thus secondary analyses will help to clarify for whom MBRP may be most effective
Detailed Description:
Stress exposure increases psychological and physiological arousal and can lead to negative health outcomes An impaired ability to self-regulate in response to stress contributes to the development of alcohol use disorders and relapse Mindfulness a state of present-focused attention and awareness can be systematically learned through meditative practice to improve self-regulation of emotional physiological and behavioral responses to stress Mindfulness meditation further facilitates a balance of mind and body thereby increasing ones ability to respond proactively and effectively to daily events Research evidence suggests a strong association between mindfulness and positive indicators of well-being which include reductions in fear anxiety anger and better physiological recovery from stress
Given the importance of self-regulation in the development and progression of alcohol use disorders and relapse a new approach to substance use treatment Mindfulness-Based Relapse Prevention MBRP was developed Traditionally MBRP is an eight-week outpatient treatment program which integrates core aspects of Relapse Prevention RP practices with practices adapted from Mindfulness-Based Stress Reduction MBSR and Mindfulness-Based Cognitive Therapy The mindfulness practices in MBRP are designed to increase acceptance and tolerance of negative emotions thoughts and physical states thus reducing the need to alleviate associated discomfort through substance use MBRP also focuses on increasing awareness of triggers and developing more effective coping behaviors in high-risk situations Among adults with substance use disorders MBRP has been found to lead to significantly lower rates of substance use greater decreases in cravings and greater increases in acceptance and acting with awareness than treatment as usual MBRP has also been found to facilitate more effective coping and self-regulation of negative emotions during early abstinence
While research indicates that MBRP is effective in reducing substance use relapse only preliminary research has examined the influence of MBRP on the physiological mechanisms involved in emotion regulation after exposure to stress Examining these physiological mechanisms is essential because the central and autonomic nervous systems work together to coordinate the self-regulation of attention cognition and emotion when stressful cues are encountered such as when a substance dependent individual is exposed to stressful andor substance related stimuli Heart rate variability HRV is generally seen as an index of emotion regulation High frequency HRV reflects parasympathetic activation of the autonomic nervous system and the bodys ability to exert cognitive control over attention and emotional responding Higher levels of HRV are associated with greater emotional and behavioral flexibility and tend to be associated with better mental and physical health outcomes In contrast lower levels of HRV are associated with a wide range of medical and psychiatric disorders including acute and chronic alcohol ingestion anxiety and depression Among alcohol dependent individuals mindfulness training has been found to increase HRV and lower subjective levels of psychological distress in response to stressful cues in the short-term The proposed study will be the first to examine the long-term effects of MBRP on HRV and self-reported psychologicalbehavioral functioning The results will provide a better understanding of the interplay between the psychological and physical mechanisms involved in relapse and help determine whether MBRP has lasting psychological and physiological benefits In other words assessing both the psychological and physiological effects of MBRP will provide a more accurate and comprehensive understanding of how mindfulness aids in promoting self-regulation and relapse prevention Finally little is known about which types of individuals are most likely to benefit from MBRP It is necessary to examine individual characteristics ie baseline levels of HRV trait mindfulness substance use anxiety depression to determine which characteristics are associated with positive treatment outcomes in both the short and long-term This knowledge will enable more efficient and effective delivery of the MBRP treatment
Given the importance of self-regulation in the development and progression of alcohol use disorders and relapse a new approach to substance use treatment Mindfulness-Based Relapse Prevention MBRP was developed Traditionally MBRP is an eight-week outpatient treatment program which integrates core aspects of Relapse Prevention RP practices with practices adapted from Mindfulness-Based Stress Reduction MBSR and Mindfulness-Based Cognitive Therapy The mindfulness practices in MBRP are designed to increase acceptance and tolerance of negative emotions thoughts and physical states thus reducing the need to alleviate associated discomfort through substance use MBRP also focuses on increasing awareness of triggers and developing more effective coping behaviors in high-risk situations Among adults with substance use disorders MBRP has been found to lead to significantly lower rates of substance use greater decreases in cravings and greater increases in acceptance and acting with awareness than treatment as usual MBRP has also been found to facilitate more effective coping and self-regulation of negative emotions during early abstinence
While research indicates that MBRP is effective in reducing substance use relapse only preliminary research has examined the influence of MBRP on the physiological mechanisms involved in emotion regulation after exposure to stress Examining these physiological mechanisms is essential because the central and autonomic nervous systems work together to coordinate the self-regulation of attention cognition and emotion when stressful cues are encountered such as when a substance dependent individual is exposed to stressful andor substance related stimuli Heart rate variability HRV is generally seen as an index of emotion regulation High frequency HRV reflects parasympathetic activation of the autonomic nervous system and the bodys ability to exert cognitive control over attention and emotional responding Higher levels of HRV are associated with greater emotional and behavioral flexibility and tend to be associated with better mental and physical health outcomes In contrast lower levels of HRV are associated with a wide range of medical and psychiatric disorders including acute and chronic alcohol ingestion anxiety and depression Among alcohol dependent individuals mindfulness training has been found to increase HRV and lower subjective levels of psychological distress in response to stressful cues in the short-term The proposed study will be the first to examine the long-term effects of MBRP on HRV and self-reported psychologicalbehavioral functioning The results will provide a better understanding of the interplay between the psychological and physical mechanisms involved in relapse and help determine whether MBRP has lasting psychological and physiological benefits In other words assessing both the psychological and physiological effects of MBRP will provide a more accurate and comprehensive understanding of how mindfulness aids in promoting self-regulation and relapse prevention Finally little is known about which types of individuals are most likely to benefit from MBRP It is necessary to examine individual characteristics ie baseline levels of HRV trait mindfulness substance use anxiety depression to determine which characteristics are associated with positive treatment outcomes in both the short and long-term This knowledge will enable more efficient and effective delivery of the MBRP treatment
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