Back to resultsStudy to Understand Pain Experiences in Relationships (SUPER)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotional Validation Training for Romantic Partners
Chronic Pain Education Training for Romantic Partners
Sponsored by
About this trial
This is an interventional other trial for Chronic Pain focused on measuring chronic pain, pain, validation, couples, romantic relationships, emotional validation
Eligibility Criteria
Inclusion Criteria:
- Romantic couples who are married or living with each other for 6 months or longer or have been in a romantic relationship 2+ years.
- One individual in the couple must have chronic muscoskeletal pain, lasting 3 months or longer. Participants may have multiple pain sites.
- The individual with chronic pain must report that their pain occurs nearly daily.
- The individual with chronic pain must have an average pain intensity of 3 or greater on an 11-point scale (from 0: no pain to 10: worst pain imaginable)
- The individual with chronic pain must have an average pain interference of 3 or greater on an 11-point scale (from 0: does not interfere to 10: completely interferes)
Exclusion Criteria:
- One or both individuals in the couple are unable to speak, read, or write in English.
- Both individuals in the couple have chronic pain. Couples may consist of one individual with chronic pain and one individual with "minimal pain", which we define as having some aspects of chronic pain but not all (e.g., has had nearly daily pain for 4 months but rates their pain below 3 in regards to interference and intensity)
- One or both individuals in the couple have widespread pain (e.g., fibromyalgia)
Sites / Locations
- Wayne State University's Relationships and Health Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Validation Training
Education Training
Arm Description
In this arm, the romantic partner of the individual with chronic pain receives training on how to validate which is provided by the research assistant.
In this arm, the romantic partner of the individual with chronic pain receives training on how to ask questions about treatments, which is provided by the research assistant.
Outcomes
Primary Outcome Measures
Pain Behavior (Behavioral coding)
Pain behaviors (e.g., grimacing, guarding) measured with behavioral coding conducted by research assistants.
Pain Intensity (0 - 10 self-report rating scale)
The individual with chronic pain will be asked to report on the pain they experienced during the discussion with their partner, controlling for their baseline pain rating at the beginning of their laboratory visit.
Pain Intensity (0 - 10 self-report rating scale)
The individual with chronic pain will be asked to report on the pain they experienced during each household task (e.g., making a bed), controlling for baseline pain rating at the beginning of their laboratory visit.
Number of Partner Validating Responses (Behavioral coding)
Validating responses will be coded by research assistants.
Number of Partner Invalidating Responses (Behavioral coding)
Invalidating responses will be coded by research assistants.
Pain-Related Emotional Disclosures (Behavioral coding)
Behavioral coding by research assistants, accounting for activity level during household tasks.
Number of Partner Validating Responses (Behavioral coding)
Validating responses will be coded by research assistants
Number of Partner Invalidating Responses (Behavioral coding)
Invalidating responses will be coded by research assistants
Partner Instrumental support (Behavioral coding)
Partner instrumental support includes number of offers of assistance, acts of assistance, and behaviors that discourage physical activity, which will be measured by behavioral coding by research assistants
Individual with Chronic Pain Assistance Behavior (Behavioral coding)
Includes requests for assistance and accepting assistance, as measured by behavioral coding conducted by a research assistant
Secondary Outcome Measures
Relationship Satisfaction (Questionnaire)
Couples Satisfaction Index, Funk & Rogge, 2007. Both partners' self-reports of relationship satisfaction.
Interpersonal Closeness (Questionnaire)
Inclusion of Other in Self Scale, Aron, Aron, & Smollan, 1992. Both partners' self-reports of interpersonal closeness.
Perceived Partner Responsiveness (Questionnaire)
Reis et al., 2003.Both partners' self-reports on Perceived Partner Responsiveness.
Pain Intensity (Questionnaire)
Brief Pain Inventory, Cleeland, 1992. The individual with chronic pain reports on their pain intensity using a 0 - 10 self-report scale, and indicates their average pain intensity over the last 24 hours.
Accuracy of Estimate of Individual with Chronic Pain's Pain Intensity
Romantic partner will be asked to estimate the individual with chronic pain's average pain intensity, which will be compared to the individual with chronic pain's report to assess accuracy.
Close other responses to pain and partner support (Questionnaire)
West Haven-Yale Multidimensional Pain Inventory, Kerns, Turk, & Rudy, 1985. Both partners' reports of partner responses to pain and partner support, i.e., self-report for the partner, and other-report for the individual with chronic pain.
Perceived Partner Validation (Questionnaire)
Both partners' reports of partner's validation behavior, i.e., self-report for the partner, and other-report for the individual with chronic pain.
Perceived Partner Invalidation (Questionnaire)
Both partners report on partner's invalidation behavior, i.e., self-report for the partner, and other-report for the individual with chronic pain.
Ambivalence about emotional expression measured by Holding Back Scale (Questionnaire)
(Holding Back Scale; Pistrang & Barker, 1995)
(Holding Back Scale; Pistrang & Barker, 1995)
(Holding Back Scale; Pistrang & Barker, 1995)
(Holding Back Scale; Pistrang & Barker, 1995)
(Holding Back Scale; Pistrang & Barker, 1995) Holding Back Scale, Pistrang & Barker, 1995; Both partners report on individual with chronic pain's behavior.
Self- and Other-Oriented Distress (Questionnaire)
Batson, Fultz, & Schoendrade, 1987. Both partners' self-report of self- and other-oriented distress.
Individual with Chronic Pain's Emotional Expression (Questionnaire)
Both partners' report on individual with chronic pain's emotional expression.
Individual with Chronic Pain's Pain Expression (Questionnaire)
Both partners' report on individual with chronic pain's pain expression.
Perceived Division of Workload and Collaboration (Questionnaire)
Both partners' report on their perceptions of division of workload and collaboration during household tasks.
Satisfaction with the discussion (Questionnaire)
Both partners' report on their satisfaction with the discussion.
Satisfaction with household tasks
Both partners' report
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02859545
Brief Title
Study to Understand Pain Experiences in Relationships
Acronym
SUPER
Official Title
Study to Understand Pain Experiences in Relationships
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic pain is a highly prevalent and costly health care problem. Yet, little is known about the optimal ways for health care providers and family members to respond to the distress expressed by people with chronic pain. The aim of the current study is to compare two models of responsiveness to identify responses that result in better functioning and adjustment. An experimental design will be used to test the extent to which emotional validation (e.g., an empathic response to distress) increases or decreases pain behaviors during physical activity. Romantic partners of individuals with chronic pain will be randomly assigned to receive validation or control training. Following training, people with chronic pain and their partners will engage in a discussion about pain and complete household tasks to examine the effects of partner training on communication, pain intensity, and pain behavior. Additionally, each individual in the couple will complete self-report measures after the discussion, after the household tasks, and one-month following the laboratory visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
chronic pain, pain, validation, couples, romantic relationships, emotional validation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Validation Training
Arm Type
Experimental
Arm Description
In this arm, the romantic partner of the individual with chronic pain receives training on how to validate which is provided by the research assistant.
Arm Title
Education Training
Arm Type
Placebo Comparator
Arm Description
In this arm, the romantic partner of the individual with chronic pain receives training on how to ask questions about treatments, which is provided by the research assistant.
Intervention Type
Behavioral
Intervention Name(s)
Emotional Validation Training for Romantic Partners
Other Intervention Name(s)
Validation
Intervention Description
In this intervention, romantic partners of individuals with chronic pain are trained individually by a research assistant. The romantic partner is trained on how to validate the individual with chronic pain's pain-related distress and given education about validation. This involves an approximately 45-minute brief, interactive training.
Intervention Type
Behavioral
Intervention Name(s)
Chronic Pain Education Training for Romantic Partners
Other Intervention Name(s)
Education
Intervention Description
In this intervention, romantic partners of individuals with chronic pain are trained individually by a research assistant. The romantic partner is trained on how to ask health professionals questions about treatment options and given health education about chronic pain. This involves an approximately 45-minute brief, interactive training.
Primary Outcome Measure Information:
Title
Pain Behavior (Behavioral coding)
Description
Pain behaviors (e.g., grimacing, guarding) measured with behavioral coding conducted by research assistants.
Time Frame
During lab visit, during household tasks conducted in the laboratory, approx. 15 - 35 mins. after partner training (intervention)
Title
Pain Intensity (0 - 10 self-report rating scale)
Description
The individual with chronic pain will be asked to report on the pain they experienced during the discussion with their partner, controlling for their baseline pain rating at the beginning of their laboratory visit.
Time Frame
During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
Title
Pain Intensity (0 - 10 self-report rating scale)
Description
The individual with chronic pain will be asked to report on the pain they experienced during each household task (e.g., making a bed), controlling for baseline pain rating at the beginning of their laboratory visit.
Time Frame
During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Title
Number of Partner Validating Responses (Behavioral coding)
Description
Validating responses will be coded by research assistants.
Time Frame
During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
Title
Number of Partner Invalidating Responses (Behavioral coding)
Description
Invalidating responses will be coded by research assistants.
Time Frame
During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
Title
Pain-Related Emotional Disclosures (Behavioral coding)
Description
Behavioral coding by research assistants, accounting for activity level during household tasks.
Time Frame
During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Title
Number of Partner Validating Responses (Behavioral coding)
Description
Validating responses will be coded by research assistants
Time Frame
During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Title
Number of Partner Invalidating Responses (Behavioral coding)
Description
Invalidating responses will be coded by research assistants
Time Frame
During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Title
Partner Instrumental support (Behavioral coding)
Description
Partner instrumental support includes number of offers of assistance, acts of assistance, and behaviors that discourage physical activity, which will be measured by behavioral coding by research assistants
Time Frame
During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Title
Individual with Chronic Pain Assistance Behavior (Behavioral coding)
Description
Includes requests for assistance and accepting assistance, as measured by behavioral coding conducted by a research assistant
Time Frame
During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Secondary Outcome Measure Information:
Title
Relationship Satisfaction (Questionnaire)
Description
Couples Satisfaction Index, Funk & Rogge, 2007. Both partners' self-reports of relationship satisfaction.
Time Frame
1-month after the intervention
Title
Interpersonal Closeness (Questionnaire)
Description
Inclusion of Other in Self Scale, Aron, Aron, & Smollan, 1992. Both partners' self-reports of interpersonal closeness.
Time Frame
During lab visit, during discussion task (approx. 5 mins. after intervention), and during household tasks (approx. 15 - 35 mins. after intervention), and 1-month after intervention
Title
Perceived Partner Responsiveness (Questionnaire)
Description
Reis et al., 2003.Both partners' self-reports on Perceived Partner Responsiveness.
Time Frame
During lab visit, during discussion task (approx. 5 mins. after intervention), and during household tasks (approx. 15 - 35 mins. after intervention), and 1-month after intervention
Title
Pain Intensity (Questionnaire)
Description
Brief Pain Inventory, Cleeland, 1992. The individual with chronic pain reports on their pain intensity using a 0 - 10 self-report scale, and indicates their average pain intensity over the last 24 hours.
Time Frame
1-month after the intervention
Title
Accuracy of Estimate of Individual with Chronic Pain's Pain Intensity
Description
Romantic partner will be asked to estimate the individual with chronic pain's average pain intensity, which will be compared to the individual with chronic pain's report to assess accuracy.
Time Frame
During lab visit, during discussion task (approx. 5 mins. after intervention), and during household tasks (approx. 15 - 35 mins. after intervention), and 1-month after intervention
Title
Close other responses to pain and partner support (Questionnaire)
Description
West Haven-Yale Multidimensional Pain Inventory, Kerns, Turk, & Rudy, 1985. Both partners' reports of partner responses to pain and partner support, i.e., self-report for the partner, and other-report for the individual with chronic pain.
Time Frame
1-month after the intervention
Title
Perceived Partner Validation (Questionnaire)
Description
Both partners' reports of partner's validation behavior, i.e., self-report for the partner, and other-report for the individual with chronic pain.
Time Frame
During lab visit, during discussion task (approx. 5 mins. after intervention), and during household tasks (approx. 15 - 35 mins. after intervention), and 1-month after intervention
Title
Perceived Partner Invalidation (Questionnaire)
Description
Both partners report on partner's invalidation behavior, i.e., self-report for the partner, and other-report for the individual with chronic pain.
Time Frame
During lab visit, during discussion task (approx. 5 mins. after intervention), and during household tasks (approx. 15 - 35 mins. after intervention), and 1-month after intervention
Title
Ambivalence about emotional expression measured by Holding Back Scale (Questionnaire)
Description
(Holding Back Scale; Pistrang & Barker, 1995)
(Holding Back Scale; Pistrang & Barker, 1995)
(Holding Back Scale; Pistrang & Barker, 1995)
(Holding Back Scale; Pistrang & Barker, 1995)
(Holding Back Scale; Pistrang & Barker, 1995) Holding Back Scale, Pistrang & Barker, 1995; Both partners report on individual with chronic pain's behavior.
Time Frame
1-month after the intervention
Title
Self- and Other-Oriented Distress (Questionnaire)
Description
Batson, Fultz, & Schoendrade, 1987. Both partners' self-report of self- and other-oriented distress.
Time Frame
During lab visit, during discussion task (approx. 5 mins. after intervention) and during household tasks (approx. 15 - 35 mins. after intervention)
Title
Individual with Chronic Pain's Emotional Expression (Questionnaire)
Description
Both partners' report on individual with chronic pain's emotional expression.
Time Frame
During lab visit, during discussion task (approx. 5 mins. after intervention), and during household tasks (approx. 15 - 35 mins. after intervention), and 1-month after intervention
Title
Individual with Chronic Pain's Pain Expression (Questionnaire)
Description
Both partners' report on individual with chronic pain's pain expression.
Time Frame
During lab visit, during discussion task (approx. 5 mins. after intervention)and during household tasks (approx. 15 - 35 mins. after intervention)
Title
Perceived Division of Workload and Collaboration (Questionnaire)
Description
Both partners' report on their perceptions of division of workload and collaboration during household tasks.
Time Frame
After household tasks (approx. 35 - 45 mins. after intervention)
Title
Satisfaction with the discussion (Questionnaire)
Description
Both partners' report on their satisfaction with the discussion.
Time Frame
After discussion (approx. 15 mins. after intervention)
Title
Satisfaction with household tasks
Description
Both partners' report
Time Frame
After household tasks (approx. 35 - 45 mins. after intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Romantic couples who are married or living with each other for 6 months or longer or have been in a romantic relationship 2+ years.
One individual in the couple must have chronic muscoskeletal pain, lasting 3 months or longer. Participants may have multiple pain sites.
The individual with chronic pain must report that their pain occurs nearly daily.
The individual with chronic pain must have an average pain intensity of 3 or greater on an 11-point scale (from 0: no pain to 10: worst pain imaginable)
The individual with chronic pain must have an average pain interference of 3 or greater on an 11-point scale (from 0: does not interfere to 10: completely interferes)
Exclusion Criteria:
One or both individuals in the couple are unable to speak, read, or write in English.
Both individuals in the couple have chronic pain. Couples may consist of one individual with chronic pain and one individual with "minimal pain", which we define as having some aspects of chronic pain but not all (e.g., has had nearly daily pain for 4 months but rates their pain below 3 in regards to interference and intensity)
One or both individuals in the couple have widespread pain (e.g., fibromyalgia)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelia M Corley, M.A.
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University's Relationships and Health Lab
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Study to Understand Pain Experiences in Relationships
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