Couples-Oriented Psychosocial Intervention for Osteoarthritis
| Tracking Information | |||||
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| First Received Date ICMJE | September 29, 2005 | ||||
| Last Updated Date | March 27, 2008 | ||||
| Start Date ICMJE | January 2000 | ||||
| Primary Completion Date | August 2004 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
patient pain, disability, and depressive symptoms. spouse stress and negative affect [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
patient pain, disability, and depressive symptoms. spouse stress and negative affect | ||||
| Change History | Complete list of historical versions of study NCT00230945 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
positive affect, exercise, spousal support and critical attitudes [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
positive affect, exercise, spousal support and critical attitudes | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Couples-Oriented Psychosocial Intervention for Osteoarthritis | ||||
| Official Title ICMJE | Psychobiological Pathways: Osteoarthritis Interventions | ||||
| 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. |
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| 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 (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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Osteoarthritis | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 543 | ||||
| Completion Date | August 2004 | ||||
| Primary Completion Date | August 2004 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00230945 | ||||
| Other Study ID Numbers ICMJE | P50 HL65111-65112--2 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Lynn M. Martire, Ph.D., Principal Investigator, University of Pittsburgh | ||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||
| Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||
| Verification Date | March 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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