Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371865
Status:
COMPLETED
Last Update Posted:
2015-04-10
First Post:
2006-08-31
Brief Title:
Behavioral Treatments for Chronic Pain
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Acceptance-Based Treatment for Chronic Pain
Status:
COMPLETED
Status Verified Date:
2015-03
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:
The purpose of the study is to test a brief group-administered psychosocial intervention to reduce interference of pain with daily life emotional distress and pain intensity and improve quality of life and physical activity levels in individuals with chronic pain
Detailed Description:
Chronic pain affects at least 15 of the veteran population and represents a high priority for the VA In addition to primary pain conditions chronic pain is a common secondary condition resulting from battlefield injuries traumatic accidents and congenital and acquired disorders Unlike most forms of acute pain treatment options available for patients suffering from chronic pain frequently offer only short-term or partial relief from symptoms The focus of rehabilitative intervention thus becomes the reduction of disability and emotional distress and improvement in quality of life and activity levels
Chronic pain rehabilitation has evolved from a primarily one-dimensional medically oriented approach to a multidisciplinary approach that incorporates a biopsychosocial formulation to pain management with physiological cognitive behavioral and emotional components This conceptualization of pain recognizes that multiple intervention modalities including psychosocial approaches are required when providing treatment to chronic pain patients
A relatively new psychosocial approach to chronic pain management and rehabilitation involves acceptance of pain-related experiences The Acceptance-based Therapy AT model is based on the theory that attempts to escape avoid or control negative experiences that cannot be changed such as chronic pain may paradoxically contribute to the increased experience of them Instead of seeking to control the negative experience AT teaches individuals to use mindfulness strategies to enlarge the scope of experience beyond pain and to engage in behaviors that are consistent with personal values and goals when total elimination of pain or other negative experiences is not possible Empirical support for acceptance-based approaches to chronic pain management is growing Data from one of the first comparisons of AT to a well-established psychosocial intervention Cognitive-Behavioral Therapy CBT performed at VASDHS by the PI suggests that AT may be superior to CBT as an adjunctive treatment for chronic pain
The proposed study assembles a multidisciplinary team with extensive experience in chronic pain interventions research to evaluate the benefits of a brief manualized group-administered psychosocial intervention which could be easily integrated into multidisciplinary pain rehabilitation programs throughout the VA system to reduce disability in veterans with chronic pain secondary to other conditions Specifically we propose to examine the effects of a promising new chronic pain intervention based on AT principles on the primary outcome of pain interference and secondary outcomes of emotional distress quality of life physical activity pain intensity and treatment satisfaction among 94 veterans with chronic benign pain as a secondary condition The AT intervention will be compared with treatment as usual TAU in a within-subjects design and with CBT in a randomized between-subjects design Outcomes include an objective measure of physical activity actigraphy as well as self-reported measures and will be evaluated at baseline 6 weeks after a TAU phase 12 weeks after treatment and at a 6-month follow-up period to investigate maintenance of gains The study design also allows for an investigation of hypothesized mechanisms of change acceptance for AT and perceived pain control for CBT Thus the proposed project has the potential to enhance the current VA standard of care as well as to add to the scientific literature on psychological models and rehabilitation of chronic pain
Chronic pain rehabilitation has evolved from a primarily one-dimensional medically oriented approach to a multidisciplinary approach that incorporates a biopsychosocial formulation to pain management with physiological cognitive behavioral and emotional components This conceptualization of pain recognizes that multiple intervention modalities including psychosocial approaches are required when providing treatment to chronic pain patients
A relatively new psychosocial approach to chronic pain management and rehabilitation involves acceptance of pain-related experiences The Acceptance-based Therapy AT model is based on the theory that attempts to escape avoid or control negative experiences that cannot be changed such as chronic pain may paradoxically contribute to the increased experience of them Instead of seeking to control the negative experience AT teaches individuals to use mindfulness strategies to enlarge the scope of experience beyond pain and to engage in behaviors that are consistent with personal values and goals when total elimination of pain or other negative experiences is not possible Empirical support for acceptance-based approaches to chronic pain management is growing Data from one of the first comparisons of AT to a well-established psychosocial intervention Cognitive-Behavioral Therapy CBT performed at VASDHS by the PI suggests that AT may be superior to CBT as an adjunctive treatment for chronic pain
The proposed study assembles a multidisciplinary team with extensive experience in chronic pain interventions research to evaluate the benefits of a brief manualized group-administered psychosocial intervention which could be easily integrated into multidisciplinary pain rehabilitation programs throughout the VA system to reduce disability in veterans with chronic pain secondary to other conditions Specifically we propose to examine the effects of a promising new chronic pain intervention based on AT principles on the primary outcome of pain interference and secondary outcomes of emotional distress quality of life physical activity pain intensity and treatment satisfaction among 94 veterans with chronic benign pain as a secondary condition The AT intervention will be compared with treatment as usual TAU in a within-subjects design and with CBT in a randomized between-subjects design Outcomes include an objective measure of physical activity actigraphy as well as self-reported measures and will be evaluated at baseline 6 weeks after a TAU phase 12 weeks after treatment and at a 6-month follow-up period to investigate maintenance of gains The study design also allows for an investigation of hypothesized mechanisms of change acceptance for AT and perceived pain control for CBT Thus the proposed project has the potential to enhance the current VA standard of care as well as to add to the scientific literature on psychological models and rehabilitation of chronic pain
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