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Couples-Oriented Psychosocial Intervention for Osteoarthritis

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00230945
First received: September 29, 2005
Last updated: March 27, 2008
Last verified: March 2008

September 29, 2005
March 27, 2008
January 2000
August 2004   (final data collection date for primary outcome measure)
patient pain, disability, and depressive symptoms. spouse stress and negative affect [ Time Frame: 6 months ] [ Designated as safety issue: No ]
patient pain, disability, and depressive symptoms. spouse stress and negative affect
Complete list of historical versions of study NCT00230945 on ClinicalTrials.gov Archive Site
positive affect, exercise, spousal support and critical attitudes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
positive affect, exercise, spousal support and critical attitudes
Not Provided
Not Provided
 
Couples-Oriented Psychosocial Intervention for Osteoarthritis
Psychobiological Pathways: Osteoarthritis Interventions

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.

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 (e.g., 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 (e.g., verbal versus nonverbal pain expression and the need to be clear about help needed) and providing spousal assistance (e.g., 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 (e.g., 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis
Behavioral: education and support intervention
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 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.
  • Experimental: 1
    Patient-oriented education and support intervention
    Intervention: Behavioral: education and support intervention
  • Experimental: 2
    Couple-oriented education and support intervention
    Intervention: Behavioral: education and support intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
543
August 2004
August 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • osteoarthritis in back, hips, and/or knees(patients) married and co-residing age 50 or older pain of at least moderate intensity difficulty with at least one instrumental ADL receiving help from spouse w/ at least one instrumental IADL

Exclusion Criteria:

  • fibromyalgia or rheumatoid arthritis taken Arthritis Self-Help Course in past 5 years
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00230945
P50 HL65111-65112--2
No
Lynn M. Martire, Ph.D., Principal Investigator, University of Pittsburgh
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Lynn M. Martire, Ph.D. University of Pittsburgh
University of Pittsburgh
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP