Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475111
Status:
COMPLETED
Last Update Posted:
2013-05-17
First Post:
2007-05-16
Brief Title:
Cognitive Behavioral Therapy Treatments for Adults With Rheumatoid Arthritis The SARA Study
Sponsor:
Arizona State University
Organization:
Arizona State University
Study Overview
Official Title:
Stress and Adaptation in Rheumatoid Arthritis SARA
Status:
COMPLETED
Status Verified Date:
2013-05
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:
Rheumatoid arthritis RA is an autoimmune disease that causes long-term inflammation of the joints and occasionally other body tissues The purpose of this study is to evaluate two different types of cognitive behavioral therapy CBT in reducing RA disease activity and improving mental health of adults with RA
Detailed Description:
Symptoms of RA include swelling pain stiffness and redness in the joints Over time joint deformity joint destruction and loss of function can occur Even simple tasks of daily living can become difficult to manage for people with RA Current treatment aims to improve symptoms but there is currently no cure for the disease Dealing with the long-term pain and the unpredictability of RA can cause symptoms of depression which is common among people with RA especially early in the disease Improving coping skills and minimizing emotional stress may help improve the overall health of people with RA CBT is a form of psychotherapy that emphasizes the important role of thinking in how we feel and what we do This type of therapy emphasizes that people can change the way they think to feel or act better even if the situation does not change The purpose of this study is to evaluate two different types of CBT that focus on stress pain and depression responses in reducing disease activity and improving mental health of adults with RA
This study will last about 15 months Initially all participants will fill out a diary report about their symptoms for a total of 30 days Half of the study participants will undergo a 2- to 3-hour lab session that will include blood collection vital signs measurements joint exams questionnaires and an interview about symptoms and medical history All participants will then be randomly assigned to one of the following three groups
People in Group 1 will participate in CBT for Pain CBT-P which will focus on altering thought processes as a way to cope more effectively with pain
People in Group 2 will participate in Mindfulness Medication for Emotion Regulation MM-ER a type of CBT that focuses on being more aware of ones emotions and regulating them
Group 3 participants will serve as controls and receive educational information on the causes of course of and treatment for RA
Participants in all three groups will attend 2-hour weekly sessions of their treatment for 8 weeks After treatment all participants will undergo a 2- to 3-hour lab session that will include blood collection vital signs measurements joint exams questionnaires and an interview about symptoms and medical history Participants will also fill out another daily diary report about their symptoms for 30 days A follow-up questionnaire will be mailed to participants 6 months following the end of treatment
This study will last about 15 months Initially all participants will fill out a diary report about their symptoms for a total of 30 days Half of the study participants will undergo a 2- to 3-hour lab session that will include blood collection vital signs measurements joint exams questionnaires and an interview about symptoms and medical history All participants will then be randomly assigned to one of the following three groups
People in Group 1 will participate in CBT for Pain CBT-P which will focus on altering thought processes as a way to cope more effectively with pain
People in Group 2 will participate in Mindfulness Medication for Emotion Regulation MM-ER a type of CBT that focuses on being more aware of ones emotions and regulating them
Group 3 participants will serve as controls and receive educational information on the causes of course of and treatment for RA
Participants in all three groups will attend 2-hour weekly sessions of their treatment for 8 weeks After treatment all participants will undergo a 2- to 3-hour lab session that will include blood collection vital signs measurements joint exams questionnaires and an interview about symptoms and medical history Participants will also fill out another daily diary report about their symptoms for 30 days A follow-up questionnaire will be mailed to participants 6 months following the end of 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AR041687 | NIH | None | httpsreporternihgovquickSearchR01AR041687 |