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Chronic Pain, Couples, & Physical Activity

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ClinicalTrials.gov Identifier: NCT04077164
Recruitment Status : Recruiting
First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Illinois Institute of Technology

Brief Summary:

Chronic pain affects more than 50 million adults in the United States (Dahlhamer, Lucas, Zelaya, Nahin, Mackey, DeBar et al., 2018) and is estimated to cost the nation more than $560 billion dollars each year (Gaskin & Richard, 2012). Regular physical activity is widely recognized as essential for maintaining health for all individuals (US Department of Health and Human Services, 2018), but is particularly important for individuals with chronic pain (ICPs) as physical activity can prevent further deconditioning and may even improve pain outcomes (e.g., CDC, 2018). Previous literature has shown that certain categories of partner behaviors (e.g., solicitous, punishing, distracting) are associated with different health outcomes for ICPs (e.g., Cano, Leonard, & Johansen, 2006), 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 (e.g., Uysal et al., 2017). Partner autonomy support has been positively associated with physical activity levels (Martire et al., 2013) and better health outcomes (Uysal et al., 2017), 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.


Condition or disease Intervention/treatment
Chronic Pain Fibromyalgia Osteoarthritis, Knee Osteoarthritis, Hip Osteoarthritis Ankylosing Spondylitis Rheumatoid Arthritis Chronic Low-back Pain Chronic Shoulder Pain Other: No intervention, observational only.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Need Supportive Interpersonal Behaviors and Physical Activity in the Context of Couples and Chronic Pain
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Group/Cohort Intervention/treatment
Individuals with Chronic Pain
Individuals who identify as having a chronic musculoskeletal pain condition.
Other: No intervention, observational only.
No intervention, this study will use self-report information regarding health, social, and behavioral factors for each member of the couple.

Partners
Partners (e.g., life partner, spouse, or significant other) of the individual with the chronic musculoskeletal pain condition.
Other: No intervention, observational only.
No intervention, this study will use self-report information regarding health, social, and behavioral factors for each member of the couple.




Primary Outcome Measures :
  1. Physical Activity as Assessed by the Physical Activity Scale for Individuals with Physical Disabilities [PASIPD] [ Time Frame: Past seven days (Prior to when participant takes cross-sectional survey.) ]
    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.

  2. Use of Need Supportive Interpersonal Behaviors as Assessed by "Interpersonal Behaviors Questionnaire" (Self-report Version) [IBQ-Self] [ Time Frame: 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. ]
    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 (αs = 0.77 to 0.82; Rocchi, Pelletier, Cheung, Baxter, & Beaudry, 2017).


Secondary Outcome Measures :
  1. Frequency of Depressive Symptoms as Assessed by Center for Epidemiologic Studies Depression Scale (CES-D-10) [ Time Frame: Past week (Prior to when participant takes cross-sectional survey.) ]
    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. Bjorgvinsson and colleagues (2013) demonstrated the scale has good reliability, a = 0.89.

  2. Frequency of Anxiety Symptoms as Assessed by GAD-7 [ Time Frame: Past 2 weeks (Prior to when participant takes cross-sectional survey.) ]
    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 (Spitzer et al., 2006).

  3. Use of Need Supportive Interpersonal Behaviors as Assessed by Interpersonal Behaviors Questionnaire (Other-report Version) [IBQ-Other] [ Time Frame: 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. ]
    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 (αs = 0.75 to 0.89; Rocchi, Pelletier, Cheung, Baxter, & Beaudry, 2017).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study will survey couples where one individual has a chronic musculoskeletal pain condition. Couples will be recruited from convenience samples via community organizations, support groups for individuals with chronic pain, and pain management service providers.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04077164


Contacts
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Contact: Melissa Ivins-Lukse, MS ‪(872) 221-4872‬ mivins@hawk.iit.edu

Locations
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United States, Illinois
Illinois Institute of Technology Recruiting
Chicago, Illinois, United States, 60616
Contact: Melissa Ivins-Lukse, MS    ‪872-221-4872‬    mivins@hawk.iit.edu   
Principal Investigator: Eun-Jeong Lee, PhD         
Sub-Investigator: Melissa Ivins-Lukse, MS         
Sponsors and Collaborators
Illinois Institute of Technology
Investigators
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Principal Investigator: Eun-Jeong Lee, PhD Illinois Institute of Technology

Additional Information:
Publications:
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.
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.

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Responsible Party: Illinois Institute of Technology
ClinicalTrials.gov Identifier: NCT04077164     History of Changes
Other Study ID Numbers: IRB#2019-027
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Currently there are no plans to share IPD with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Illinois Institute of Technology:
Couples
Relationships
Physical Activity
Additional relevant MeSH terms:
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Spondylitis
Osteoarthritis
Fibromyalgia
Spondylitis, Ankylosing
Osteoarthritis, Knee
Shoulder Pain
Osteoarthritis, Hip
Low Back Pain
Chronic Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Arthralgia