NCT04077164

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 9, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

1.7 years

First QC Date

August 5, 2019

Last Update Submit

October 6, 2023

Conditions

Keywords

CouplesRelationshipsPhysical Activity

Outcome Measures

Primary Outcomes (2)

  • 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.)

  • 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 (αs = 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 Outcomes (3)

  • Frequency of Depressive Symptoms as Assessed by Center for Epidemiologic Studies Depression Scale (CES-D-10)

    Past week (Prior to when participant takes cross-sectional survey.)

  • Frequency of Anxiety Symptoms as Assessed by GAD-7

    Past 2 weeks (Prior to when participant takes cross-sectional survey.)

  • Use of Need Supportive Interpersonal Behaviors as Assessed by Interpersonal Behaviors Questionnaire (Other-report Version) [IBQ-Other]

    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.

Study Arms (2)

Individuals with Chronic Pain

Individuals who identify as having a chronic musculoskeletal pain condition.

Other: No intervention, observational only.

Partners

Partners (e.g., life partner, spouse, or significant other) of the individual with the chronic musculoskeletal pain condition.

Other: No intervention, observational only.

Interventions

No intervention, this study will use self-report information regarding health, social, and behavioral factors for each member of the couple.

Individuals with Chronic PainPartners

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • One or both individuals are 17 years old or younger.
  • Neither individual identifies as having a chronic musculoskeletal pain condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Illinois Institute of Technology

Chicago, Illinois, 60616, United States

Location

Related Publications (17)

  • 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.

    BACKGROUND
  • 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.

    PMID: 11833022BACKGROUND
  • 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.

    PMID: 29251089BACKGROUND
  • 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.

    PMID: 16717171BACKGROUND
  • 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.

    PMID: 8037935BACKGROUND
  • 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.

    PMID: 22726453BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 10981840BACKGROUND
  • 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.

    PMID: 15769225BACKGROUND
  • 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.

    PMID: 4088697BACKGROUND
  • 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.

    PMID: 16298062BACKGROUND
  • 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.

    PMID: 25929153BACKGROUND
  • 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.

    PMID: 22607834BACKGROUND
  • 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.

    PMID: 30212442BACKGROUND
  • 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.

    PMID: 16750794BACKGROUND
  • 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.

    PMID: 23161472BACKGROUND
  • 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.

    PMID: 27541643BACKGROUND

Related Links

MeSH Terms

Conditions

Chronic PainFibromyalgiaOsteoarthritis, KneeOsteoarthritis, HipOsteoarthritisSpondylitis, AnkylosingArthritis, RheumatoidMotor Activity

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesArthritisJoint DiseasesAxial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesAnkylosisConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Eun-Jeong Lee, PhD

    Illinois Institute of Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2019

First Posted

September 4, 2019

Study Start

April 9, 2019

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations