Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230945
Status:
COMPLETED
Last Update Posted:
2008-03-28
First Post:
2005-09-29
Brief Title:
Couples-Oriented Psychosocial Intervention for Osteoarthritis
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Psychobiological Pathways Osteoarthritis Interventions
Status:
COMPLETED
Status Verified Date:
2008-03
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 this study is to determine if osteoarthritis patients and their spouses experience greater health benefits from a couples-oriented psychosocial intervention than a patient-oriented psychosocial intervention and to determine if each intervention is more beneficial than patient usual medical care
Detailed Description:
The patient-oriented education and support intervention PES is based on the Arthritis Self-Management Program a group intervention that consists of 6 weekly 2 hour sessions shown to successfully reduce pain severity and depressive symptomatology and to enhance a sense of efficacy in managing arthritis pain and other symptoms The PES specifically focuses on self-management of arthritis and no spouses family members or friends participate in PES sessions Major components of the sessions include information regarding the etiology and treatment of arthritis self-management strategies for managing pain and strengthening joints the benefits of exercise communication skills and ways to effectively cope with negative emotions At the end of each weekly session each participant sets a health-related goal eg walk for exercise three times over the next week At the beginning of the next session each participant reports on his or her success in meeting this goal and receives feedback from the group Participants in the PES are encouraged to communicate with and be a source of support to one another both within and outside the sessions The PES facilitator is an individual who was trained by staff of the Arthritis Foundation to lead the Arthritis Self-Management Program and who follows a detailed intervention manual created for this Program and for the present study
The couple-oriented education and support intervention CES is a group education and support intervention that consisted of 6 weekly 2 hour sessions attended by individuals with OA and their spouses All components of the PES are covered in the CES using the standard format and topics are framed as couples issues whenever possible An overarching framework introduced in the first session of the CES is that pain is a complex experience which can be influenced by thoughts feelings and behaviors spouses can influence and be affected by these same thoughts feelings and behaviors and spouses concerns and experiences as support providers are important to address Each of the next 5 sessions is supplemented by a component that was linked to a topic covered in the PES and explicitly extended to couples For example a topic of the third session of the PES deals with managing fatigue and the supplemental component for this session provides information on the most effective and ineffective strategies for requesting spousal assistance eg verbal versus nonverbal pain expression and the need to be clear about help needed and providing spousal assistance eg consider timing and amount of assistance desired The supplemental components for the 4 remaining sessions address spouse encouragement and practice of cognitive or behavioral pain management strategies eg distraction and progressive muscle relaxation supportive and unsupportive spousal communications reducing negative emotional contagion between partners and couples strategies for managing medications At the end of each weekly session of the CES each individual with OA and his or her spouse sets health-related goals for the following week and their success in meeting these goals iss reviewed with the group at the beginning of the next session Spouses are instructed to set goals that were facilitative of their partners goals whenever possible Couples in the CES are encouraged to communicate with and be a source of support to one another both within and outside the course The CES facilitator is trained in the Arthritis Self-Management Program by staff of the Arthritis Foundation and in the couples materials by study investigators and follows a detailed intervention manual
The no-treatment control group received usual medical care only
The couple-oriented education and support intervention CES is a group education and support intervention that consisted of 6 weekly 2 hour sessions attended by individuals with OA and their spouses All components of the PES are covered in the CES using the standard format and topics are framed as couples issues whenever possible An overarching framework introduced in the first session of the CES is that pain is a complex experience which can be influenced by thoughts feelings and behaviors spouses can influence and be affected by these same thoughts feelings and behaviors and spouses concerns and experiences as support providers are important to address Each of the next 5 sessions is supplemented by a component that was linked to a topic covered in the PES and explicitly extended to couples For example a topic of the third session of the PES deals with managing fatigue and the supplemental component for this session provides information on the most effective and ineffective strategies for requesting spousal assistance eg verbal versus nonverbal pain expression and the need to be clear about help needed and providing spousal assistance eg consider timing and amount of assistance desired The supplemental components for the 4 remaining sessions address spouse encouragement and practice of cognitive or behavioral pain management strategies eg distraction and progressive muscle relaxation supportive and unsupportive spousal communications reducing negative emotional contagion between partners and couples strategies for managing medications At the end of each weekly session of the CES each individual with OA and his or her spouse sets health-related goals for the following week and their success in meeting these goals iss reviewed with the group at the beginning of the next session Spouses are instructed to set goals that were facilitative of their partners goals whenever possible Couples in the CES are encouraged to communicate with and be a source of support to one another both within and outside the course The CES facilitator is trained in the Arthritis Self-Management Program by staff of the Arthritis Foundation and in the couples materials by study investigators and follows a detailed intervention manual
The no-treatment control group received usual medical care only
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