Rheumatoid Arthritis Clinical Trial
Official title:
Need Supportive Interpersonal Behaviors and Physical Activity in the Context of Couples and Chronic Pain
Verified date | October 2023 |
Source | Illinois Institute of Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Chronic pain affects more than 50 million adults in the United States and is estimated to cost the nation more than $560 billion dollars each year. Regular physical activity is widely recognized as essential for maintaining health for all individuals, but is particularly important for individuals with chronic pain (ICPs) as physical activity can prevent further deconditioning and may even improve pain outcomes. Previous literature has shown that certain categories of partner behaviors (e.g., solicitous, punishing, distracting) are associated with different health outcomes for ICPs, and recently researchers have begun examining partner behaviors through the lens of Self-Determination Theory, specifically looking at the effects of autonomy support from a spouse on physical activity among ICPs. Partner autonomy support has been positively associated with physical activity levels and better health outcomes, but no studies to date have explored what factors predict whether or not a partner will use an autonomy supportive interpersonal style (as opposed to a controlling interpersonal style) with the ICP. Similarly, more research is needed on the mechanisms by which autonomy support promotes positive outcomes for ICPs. Though receiving autonomy support has been linked to increased physical activity and improved mental health, no studies have yet tested the full Self-Determination Theory model as one possible explanation of the link between this form of partner support and desirable health outcomes. In particular, it is important to understand the ICP's perspective on how partner autonomy support influences need satisfaction and autonomous motivation as possible mediators between autonomy support and ICP physical activity. Furthermore, little research has explored other need supportive behaviors or their need frustrating counterparts. The current study will not only provide greater understanding of autonomy support, but will also expand the literature regarding these other need supportive and need thwarting behaviors. Lastly, given the value of need supportive behaviors from one's partner, it is essential to evaluate how partner perceptions of those need supportive behaviors align with ICP's perceptions of those behaviors. Any need support a partner provides is likely moderated by the ICP's perception of that support.
Status | Terminated |
Enrollment | 400 |
Est. completion date | December 30, 2020 |
Est. primary completion date | December 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Currently in a relationship for at least 1 year or more. - Both individuals in the relationship are 18 years or older. - One individual in the relationship identifies as having a chronic musculoskeletal pain condition. Exclusion Criteria: - One or both individuals are 17 years old or younger. - Neither individual identifies as having a chronic musculoskeletal pain condition. |
Country | Name | City | State |
---|---|---|---|
United States | Illinois Institute of Technology | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Illinois Institute of Technology |
United States,
Andresen EM, Malmgren JA, Carter WB, Patrick DL. Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med. 1994 Mar-Apr;10(2):77-84. — View Citation
Cano A, Leonard MT, Franz A. The significant other version of the Pain Catastrophizing Scale (PCS-S): preliminary validation. Pain. 2005 Dec 15;119(1-3):26-37. doi: 10.1016/j.pain.2005.09.009. Epub 2005 Nov 17. — View Citation
Dahlhamer J, Lucas J, Zelaya C, Nahin R, Mackey S, DeBar L, Kerns R, Von Korff M, Porter L, Helmick C. Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults - United States, 2016. MMWR Morb Mortal Wkly Rep. 2018 Sep 14;67(36):1001-1006. doi: 10.15585/mmwr.mm6736a2. — View Citation
Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain. 2012 Aug;13(8):715-24. doi: 10.1016/j.jpain.2012.03.009. Epub 2012 May 16. — View Citation
Kerns RD, Turk DC, Rudy TE. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain. 1985 Dec;23(4):345-356. doi: 10.1016/0304-3959(85)90004-1. — View Citation
Kindt S, Vansteenkiste M, Loeys T, Cano A, Lauwerier E, Verhofstadt LL, Goubert L. When Is Helping your Partner with Chronic Pain a Burden? The Relation Between Helping Motivation and Personal and Relational Functioning. Pain Med. 2015 Sep;16(9):1732-44. doi: 10.1111/pme.12766. Epub 2015 Apr 30. — View Citation
La Guardia JG, Ryan RM, Couchman CE, Deci EL. Within-person variation in security of attachment: a self-determination theory perspective on attachment, need fulfillment, and well-being. J Pers Soc Psychol. 2000 Sep;79(3):367-84. doi: 10.1037//0022-3514.79.3.367. — View Citation
Leonard MT, Cano A, Johansen AB. Chronic pain in a couples context: a review and integration of theoretical models and empirical evidence. J Pain. 2006 Jun;7(6):377-90. doi: 10.1016/j.jpain.2006.01.442. — View Citation
Markland, D., & Tobin, V. (2004). A modification to the behavioural regulation in exercise questionnaire to include an assessment of amotivation. Journal of Sport and Exercise Psychology, 26(2), 191-196.
Martire LM, Stephens MA, Mogle J, Schulz R, Brach J, Keefe FJ. Daily spousal influence on physical activity in knee osteoarthritis. Ann Behav Med. 2013 Apr;45(2):213-23. doi: 10.1007/s12160-012-9442-x. — View Citation
Rocchi M, Pelletier LG. The Antecedents of Coaches' Interpersonal Behaviors: The Role of the Coaching Context, Coaches' Psychological Needs, and Coaches' Motivation. J Sport Exerc Psychol. 2017 Oct 1;39(5):366-378. doi: 10.1123/jsep.2016-0267. Epub 2017 Dec 18. — View Citation
Rocchi, M., Pelletier, L., Cheung, S., Baxter, D., & Beaudry, S. (2017). Assessing need-supportive and need-thwarting interpersonal behaviours: The Interpersonal Behaviours Questionnaire (IBQ). Personality and Individual Differences, 104, 423-433.
Sabourin S, Valois P, Lussier Y. Development and validation of a brief version of the dyadic adjustment scale with a nonparametric item analysis model. Psychol Assess. 2005 Mar;17(1):15-27. doi: 10.1037/1040-3590.17.1.15. — View Citation
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. — View Citation
Teixeira PJ, Carraca EV, Markland D, Silva MN, Ryan RM. Exercise, physical activity, and self-determination theory: a systematic review. Int J Behav Nutr Phys Act. 2012 Jun 22;9:78. doi: 10.1186/1479-5868-9-78. — View Citation
Uysal A, Ascigil E, Turunc G. Spousal autonomy support, need satisfaction, and well-being in individuals with chronic pain: A longitudinal study. J Behav Med. 2017 Apr;40(2):281-292. doi: 10.1007/s10865-016-9783-1. Epub 2016 Aug 19. — View Citation
Washburn RA, Zhu W, McAuley E, Frogley M, Figoni SF. The physical activity scale for individuals with physical disabilities: development and evaluation. Arch Phys Med Rehabil. 2002 Feb;83(2):193-200. doi: 10.1053/apmr.2002.27467. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical Activity as Assessed by the Physical Activity Scale for Individuals with Physical Disabilities [PASIPD] | This 13-item scale measures physical activity among individuals with physical disabilities. Respondents report approximately how much time they engage in 1) home repair and lawn and garden work, 2) housework, 3) vigorous sport and recreation, 4) moderate sport and recreation, and 5) occupation and transportation. Respondents answer on a 4-point Likert scale, with responses ranging from 1 (Never) to 4 (Often) or from 1 (Less than 1 hr) to 4 (More than 4hr). Items 2-13 are used to calculate the total score; the average hours per day in an activity are multiplied by a value of metabolic equivalents (METs, provided with the PASIPD scale), these values are then summed to calculate the total MET hour/day. | Past seven days (Prior to when participant takes cross-sectional survey.) | |
Primary | Use of Need Supportive Interpersonal Behaviors as Assessed by "Interpersonal Behaviors Questionnaire" (Self-report Version) [IBQ-Self] | The IBQ-Self is a 24-item self-report scale that measures how much an individual engages with others via behaviors that either support or thwart basic psychological needs (autonomy, competence, & relatedness). There are six subscales, each consists of four items, which are summed to provide a subscore, ranging from 4 to 28. Higher scores for a subscale indicate that an individual perceives they use those particular behaviors more frequently. Higher scores for autonomy support, competence support, and relatedness support are considered desirable, while lower scores for autonomy thwarting, competence thwarting, and relatedness thwarting are also viewed as more adaptive. Cronbach's alphas for the six subscales indicate acceptable reliability (as = 0.77 to 0.82). | Up to 2 weeks. Participant will answer while completing cross-sectional survey, for most this is less than 30 minutes, however, participants have up to 2 weeks to complete survey. Participant responds regarding how they usually interact with partner. | |
Secondary | Frequency of Depressive Symptoms as Assessed by Center for Epidemiologic Studies Depression Scale (CES-D-10) | The CES-D-10 is a self-report measure that assesses depressive symptomatology. Respondents rate items on a 4-point Likert scale describing how often the participant felt or behaved in a certain way during the past week. The responses range from 0 "Rarely or none of the time (less than 1 day)" to 3 "Most or all of the time (5-7 days)." A total score on the CES-D-10 is yielded by summing the scores for all items, and may range from 0 to 30. A score of 10 or greater is used as a screening cutoff to indicate the presence of depression. Lower scores indicate fewer depressive symptoms and are considered desirable. The scale has good reliability, a = 0.89. | Past week (Prior to when participant takes cross-sectional survey.) | |
Secondary | Frequency of Anxiety Symptoms as Assessed by GAD-7 | The GAD-7 is a 7-item self-report measure that assesses symptomatology consistent with generalized anxiety disorder. Each item is rated on a 4-point Likert scale describing how often the participant has experienced possible symptoms. The responses range from 0 "Not at all" to 3 "Nearly every day." Total scores are calculated for the GAD-7 by summing all the items, and may range from 0 to 21. Lower scores indicate fewer anxiety symptoms and are indicative of greater wellbeing. A cut point score of 10 or higher has been shown to have good specificity (89%) and sensitivity (82%) for identifying individuals with and without generalized anxiety disorder. The GAD-7 has demonstrated good internal consistency, with Cronbach's alpha at 0.92. | Past 2 weeks (Prior to when participant takes cross-sectional survey.) | |
Secondary | Use of Need Supportive Interpersonal Behaviors as Assessed by Interpersonal Behaviors Questionnaire (Other-report Version) [IBQ-Other] | The IBQ-Other is a 24-item self-report scale that measures how an individual perceives others' interactions with them in terms of supporting or thwarting the respondent's basic psychological needs (autonomy, competence & relatedness). There are six subscales, each consists of four items, which are summed to provide a subscore ranging from 4 to 28. Higher scores for a subscale indicate that an individual perceives that people they interact with use those particular behaviors more frequently. Higher scores for autonomy support, competence support, relatedness support, and lower scores for autonomy thwarting, competence thwarting, and relatedness thwarting are considered desirable. Cronbach's alphas for the six subscales indicate acceptable reliability (as = 0.75 to 0.89). | Up to 2 weeks. Participant will answer while completing cross-sectional survey, for most this is less than 30 minutes, however, participants have up to 2 weeks to complete survey. Participant responds regarding how partner typically interacts with them. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |