Ignite Creation Date:
2024-05-06 @ 1:05 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03933839
Status:
COMPLETED
Last Update Posted:
2020-05-20
First Post:
2019-04-29
Brief Title:
Internet-Based Pain Coping Skills Training for Patients With Lupus
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Internet-Based Pain Coping Skills Training PainCOACH for Patients With Lupus
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:
PainCOACH
Brief Summary:
This is a pilot study of an automated internet-based pain coping skills training PCST program PainCOACH
Detailed Description:
Background and Significance Systemic lupus erythematosus SLE is a chronic autoimmune disease that impacts multiple organ systems SLE results in a variety of challenging symptoms including flare-ups and periods of remission that are unpredictable and it is a complex disease to manage clinically Because of these factors SLE often has a major impact on patients quality of life Notably SLE is often associated with pain fatigue emotional symptoms like anxiety and depression and disability Because of the relatively young average age of SLE onset many patients must navigate these challenges while maintaining work and or caring for young children
Prior studies show that greater use of adaptive coping strategies and greater self-efficacy for coping with SLE-related symptoms are associated with better physical and psychological outcomes Conversely maladaptive coping behaviors particularly pain catastrophizing eg focusing on and exaggerating the threat of pain and negatively evaluating ones ability to deal with pain are associated with poorer SLE outcomes Importantly many studies in other rheumatic conditions have shown that pain coping skills training PCST programs can improve coping patterns as well as physical and psychological health outcomes However there have been no trials of PCST among individuals with SLE who face a unique set of disease-related challenges and are overall younger than patients with many other rheumatic conditions Delivery of PCST programs to patients with SLE could have a tremendous impact on outcomes and quality of life but this evidence base needs to be established including adaptations of current PCST programs that may be important specifically for patients with SLE Therefore the objective of this project is to conduct a pilot study of an automated internet-based PCST program PainCOACH that has been shown to improve multiple key outcomes among patients with osteoarthritis
Study Aims This project has three specific aims 1 Evaluate the feasibility and acceptability of PainCOACH among patients with SLE 2 Obtain a preliminary assessment of the efficacy of PainCOACH relative to a wait list control group for improving pain interference and other key outcomes among patients with SLE 3 Determine appropriate adaptations to PainCOACH for patients with SLE
Study Description Investigators will conduct a randomized pilot study with N60 patients age 18 years with physician diagnosis of systemic lupus erythematosus SLE equally allocated to PainCOACH and a wait list control group that will be offered PainCOACH after completion of the 9 week follow-up assessment This design will allow a between-group comparison as well as collection of acceptability data from the control group following their completion of PainCOACH Outcomes will be assessed at baseline and at about 9 week follow-up as PainCOACH is designed for delivery over 8 weeks
Prior studies show that greater use of adaptive coping strategies and greater self-efficacy for coping with SLE-related symptoms are associated with better physical and psychological outcomes Conversely maladaptive coping behaviors particularly pain catastrophizing eg focusing on and exaggerating the threat of pain and negatively evaluating ones ability to deal with pain are associated with poorer SLE outcomes Importantly many studies in other rheumatic conditions have shown that pain coping skills training PCST programs can improve coping patterns as well as physical and psychological health outcomes However there have been no trials of PCST among individuals with SLE who face a unique set of disease-related challenges and are overall younger than patients with many other rheumatic conditions Delivery of PCST programs to patients with SLE could have a tremendous impact on outcomes and quality of life but this evidence base needs to be established including adaptations of current PCST programs that may be important specifically for patients with SLE Therefore the objective of this project is to conduct a pilot study of an automated internet-based PCST program PainCOACH that has been shown to improve multiple key outcomes among patients with osteoarthritis
Study Aims This project has three specific aims 1 Evaluate the feasibility and acceptability of PainCOACH among patients with SLE 2 Obtain a preliminary assessment of the efficacy of PainCOACH relative to a wait list control group for improving pain interference and other key outcomes among patients with SLE 3 Determine appropriate adaptations to PainCOACH for patients with SLE
Study Description Investigators will conduct a randomized pilot study with N60 patients age 18 years with physician diagnosis of systemic lupus erythematosus SLE equally allocated to PainCOACH and a wait list control group that will be offered PainCOACH after completion of the 9 week follow-up assessment This design will allow a between-group comparison as well as collection of acceptability data from the control group following their completion of PainCOACH Outcomes will be assessed at baseline and at about 9 week follow-up as PainCOACH is designed for delivery over 8 weeks
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