Chronic PainNCT04077164
Chronic Pain, Couples, & Physical Activity
An observational study of Chronic Pain and Fibromyalgia, run by Illinois Institute of Technology at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Fibromyalgia, Osteoarthritis, Knee
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2019to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- One or both individuals are 17 years old or younger.
- Neither individual identifies as having a chronic musculoskeletal pain condition.
Trial locations and contacts
1 site in 1 country.
United States1 site
Illinois Institute of Technology
Chicago, Illinois, 60616
About this study
Official title: Need Supportive Interpersonal Behaviors and Physical Activity in the Context of Couples and Chronic Pain
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.
Read the detailed description
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.
Self-determination theory (SDT) posits that contextual, perceptual, and individual factors may influence how much an individual uses an autonomy supportive interpersonal style through the mediators of basic psychological need satisfaction and on autonomous motivation.
The present study used path analysis to test a SDT model of the relationships between a contextual factor (autonomy support from health care provider), a perceptual factor (partner's perception of ICP motivation for physical activity), an individual factor (partner catastrophizing about ICP's pain), and the sequential mediators of relationship need satisfaction and autonomous motivation with respect to the dependent variable of partner's use of an autonomy supportive interpersonal style.
- Conditions
- Chronic Pain, Fibromyalgia, Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis, Ankylosing Spondylitis
- Being tested
- No intervention, observational only.
- Keywords
- Couples, Relationships, Physical Activity
- Medical subject headings
- Chronic Pain, Fibromyalgia, Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis, Spondylitis, Ankylosing, Arthritis, Rheumatoid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observational only.Other
No intervention, this study will use self-report information regarding health, social, and behavioral factors for each member of the couple.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with Chronic Pain | Individuals who identify as having a chronic musculoskeletal pain condition. Receives: Other: No intervention, observational only. | |
| Partners | Partners (e.g., life partner, spouse, or significant other) of the individual with the chronic musculoskeletal pain condition. Receives: Other: No intervention, observational only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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)
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.
Measured: Past week (Prior to when participant takes cross-sectional survey.)
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.
Measured: 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]
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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start9 Apr 2019
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Why it stopped: Resources not available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Illinois Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eun-Jeong Lee, PhD, Principal investigator, Illinois Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077164
- Sponsor's protocol ID
- IRB#2019-027
- Status last verified
- Oct 2023
- First submitted
- 5 Aug 2019
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently there are no plans to share IPD with other researchers.
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.
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.
PubMed 11833022Rocchi 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.
PubMed 29251089Spitzer 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.
PubMed 16717171Andresen 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.
PubMed 8037935Teixeira 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.
PubMed 22726453Markland, 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.
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.
PubMed 10981840Sabourin 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.
PubMed 15769225Kerns 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.
PubMed 4088697Cano 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.
PubMed 16298062Kindt 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.
PubMed 25929153Gaskin 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.
PubMed 22607834Dahlhamer 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.
PubMed 30212442Leonard 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.
PubMed 16750794
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Need Supportive Interpersonal Behaviors and Physical Activity in the Context of Couples and Chronic Pain
- ClinicalTrials.gov ID
- NCT04077164
- Acronym / sponsor ID
- IRB#2019-027
- Conditions
- Chronic Pain, Fibromyalgia, Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis, Ankylosing Spondylitis
- Keywords
- Couples, Relationships, Physical Activity
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Resources not available.
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Illinois Institute of TechnologyUniversity, hospital or other
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Self-determination theory (SDT) posits that contextual, perceptual, and individual factors may influence how much an individual uses an autonomy supportive interpersonal style through the mediators of basic psychological need satisfaction and on autonomous motivation.
The present study used path analysis to test a SDT model of the relationships between a contextual factor (autonomy support from health care provider), a perceptual factor (partner's perception of ICP motivation for physical activity), an individual factor (partner catastrophizing about ICP's pain), and the sequential mediators of relationship need satisfaction and autonomous motivation with respect to the dependent variable of partner's use of an autonomy supportive interpersonal style.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with Chronic Pain | – | Other: No intervention, observational only.Individuals who identify as having a chronic musculoskeletal pain condition. |
| Partners | – | Other: No intervention, observational only.Partners (e.g., life partner, spouse, or significant other) of the individual with the chronic musculoskeletal pain condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- One or both individuals are 17 years old or younger.
- Neither individual identifies as having a chronic musculoskeletal pain condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Individuals with Chronic Pain, Partners |
Primary outcome
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.
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).
3 secondary outcomes
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.)
Frequency of Anxiety Symptoms as Assessed by GAD-7
Time frame: 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]
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.
Results and safety
The study was stopped early (reason given: Resources not available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- BackgroundRocchi, 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: PubMed 11833022Washburn 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.
- Background: PubMed 29251089Rocchi 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.
- Background: PubMed 16717171Spitzer 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.
- Background: PubMed 8037935Andresen 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.
- Background: PubMed 22726453Teixeira 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.
- BackgroundMarkland, 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: PubMed 10981840La 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.
- Background: PubMed 15769225Sabourin 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.
- Background: PubMed 4088697Kerns 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.
- Background: PubMed 16298062Cano 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.
- Background: PubMed 25929153Kindt 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.
- Online form for individuals who would like to be contacted about participating in the study.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Currently there are no plans to share IPD with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eun-Jeong Lee, PhD principal investigator
Illinois Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Fibromyalgia, run by Illinois Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Resources not available.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04077164, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.