Study to Understand Pain Experiences in Relationships (SUPER)

April 21, 2019 updated by: Angelia Corley, Wayne State University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Wayne State University's Relationships and Health Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Validation Training
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.
Behavioral: Emotional Validation Training for Romantic Partners
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.
Other Names:
  • Validation
Placebo Comparator: Education Training
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.
Behavioral: Chronic Pain Education Training for Romantic Partners
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.
Other Names:
  • Education

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain Behavior (Behavioral coding)
Time Frame: During lab visit, during household tasks conducted in the laboratory, approx. 15 - 35 mins. after partner training (intervention)
Pain behaviors (e.g., grimacing, guarding) measured with behavioral coding conducted by research assistants.
During lab visit, during household tasks conducted in the laboratory, approx. 15 - 35 mins. after partner training (intervention)
Pain Intensity (0 - 10 self-report rating scale)
Time Frame: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
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.
During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
Pain Intensity (0 - 10 self-report rating scale)
Time Frame: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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.
During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Number of Partner Validating Responses (Behavioral coding)
Time Frame: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
Validating responses will be coded by research assistants.
During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
Number of Partner Invalidating Responses (Behavioral coding)
Time Frame: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
Invalidating responses will be coded by research assistants.
During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
Pain-Related Emotional Disclosures (Behavioral coding)
Time Frame: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Behavioral coding by research assistants, accounting for activity level during household tasks.
During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Number of Partner Validating Responses (Behavioral coding)
Time Frame: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Validating responses will be coded by research assistants
During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Number of Partner Invalidating Responses (Behavioral coding)
Time Frame: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Invalidating responses will be coded by research assistants
During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Partner Instrumental support (Behavioral coding)
Time Frame: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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
During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Individual with Chronic Pain Assistance Behavior (Behavioral coding)
Time Frame: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Includes requests for assistance and accepting assistance, as measured by behavioral coding conducted by a research assistant
During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relationship Satisfaction (Questionnaire)
Time Frame: 1-month after the intervention
Couples Satisfaction Index, Funk & Rogge, 2007. Both partners' self-reports of relationship satisfaction.
1-month after the intervention
Interpersonal Closeness (Questionnaire)
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
Inclusion of Other in Self Scale, Aron, Aron, & Smollan, 1992. Both partners' self-reports of interpersonal closeness.
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
Perceived Partner Responsiveness (Questionnaire)
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
Reis et al., 2003.Both partners' self-reports on Perceived Partner Responsiveness.
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
Pain Intensity (Questionnaire)
Time Frame: 1-month after the intervention
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.
1-month after the intervention
Accuracy of Estimate of Individual with Chronic Pain's Pain Intensity
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
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.
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
Close other responses to pain and partner support (Questionnaire)
Time Frame: 1-month after the intervention
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.
1-month after the intervention
Perceived Partner Validation (Questionnaire)
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
Both partners' reports of partner's validation behavior, i.e., self-report for the partner, and other-report for the individual with chronic pain.
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
Perceived Partner Invalidation (Questionnaire)
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
Both partners report on partner's invalidation behavior, i.e., self-report for the partner, and other-report for the individual with chronic pain.
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
Ambivalence about emotional expression measured by Holding Back Scale (Questionnaire)
Time Frame: 1-month after the intervention
  • (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.
1-month after the intervention
Self- and Other-Oriented Distress (Questionnaire)
Time Frame: During lab visit, during discussion task (approx. 5 mins. after intervention) and during household tasks (approx. 15 - 35 mins. after intervention)
Batson, Fultz, & Schoendrade, 1987. Both partners' self-report of self- and other-oriented distress.
During lab visit, during discussion task (approx. 5 mins. after intervention) and during household tasks (approx. 15 - 35 mins. after intervention)
Individual with Chronic Pain's Emotional Expression (Questionnaire)
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
Both partners' report on individual with chronic pain's emotional expression.
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
Individual with Chronic Pain's Pain Expression (Questionnaire)
Time Frame: During lab visit, during discussion task (approx. 5 mins. after intervention)and during household tasks (approx. 15 - 35 mins. after intervention)
Both partners' report on individual with chronic pain's pain expression.
During lab visit, during discussion task (approx. 5 mins. after intervention)and during household tasks (approx. 15 - 35 mins. after intervention)
Perceived Division of Workload and Collaboration (Questionnaire)
Time Frame: After household tasks (approx. 35 - 45 mins. after intervention)
Both partners' report on their perceptions of division of workload and collaboration during household tasks.
After household tasks (approx. 35 - 45 mins. after intervention)
Satisfaction with the discussion (Questionnaire)
Time Frame: After discussion (approx. 15 mins. after intervention)
Both partners' report on their satisfaction with the discussion.
After discussion (approx. 15 mins. after intervention)
Satisfaction with household tasks
Time Frame: After household tasks (approx. 35 - 45 mins. after intervention)
Both partners' report
After household tasks (approx. 35 - 45 mins. after intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wayne State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Angelia M Corley, M.A., Wayne State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACorley

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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