Chronic PainSUPERNCT02859545
Study to Understand Pain Experiences in Relationships
A study testing Emotional Validation Training for Romantic Partners and Chronic Pain Education Training for Romantic Partners in people with Chronic Pain, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Emotional Validation Training for Romantic Partners and Chronic Pain Education Training for Romantic Partners
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jun 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wayne State University's Relationships and Health Lab
Detroit, Michigan, 48202
About this study
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.
- Conditions
- Chronic Pain
- Being tested
- Emotional Validation Training for Romantic Partners, Chronic Pain Education Training for Romantic Partners
- Keywords
- chronic pain, pain, validation, couples, romantic relationships, emotional validation
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional Validation Training for Romantic PartnersBehavioural
Also called Validation
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.
Chronic Pain Education Training for Romantic PartnersBehavioural
Also called Education
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.
| Study group | Role | What they receive |
|---|---|---|
| Validation Training | Experimental | 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. Receives: Behavioral: Emotional Validation Training for Romantic Partners |
| Education Training | Placebo comparator | 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. Receives: Behavioral: Chronic Pain Education Training for Romantic Partners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Behavior (Behavioral coding)
Pain behaviors (e.g., grimacing, guarding) measured with behavioral coding conducted by research assistants.
Measured: 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)
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.
Measured: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
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.
Measured: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Number of Partner Validating Responses (Behavioral coding)
Validating responses will be coded by research assistants.
Measured: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
Number of Partner Invalidating Responses (Behavioral coding)
Invalidating responses will be coded by research assistants.
Measured: During lab visit, during discussion task, approx. 5 minutes after partner training (intervention)
Pain-Related Emotional Disclosures (Behavioral coding)
Behavioral coding by research assistants, accounting for activity level during household tasks.
Measured: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Number of Partner Validating Responses (Behavioral coding)
Validating responses will be coded by research assistants
Measured: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Number of Partner Invalidating Responses (Behavioral coding)
Invalidating responses will be coded by research assistants
Measured: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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
Measured: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
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
Measured: During lab visit, during household tasks, approx. 15 - 35 mins. after partner training (intervention)
Secondary outcomes (15)
Relationship Satisfaction (Questionnaire)
Couples Satisfaction Index, Funk \& Rogge, 2007. Both partners' self-reports of relationship satisfaction.
Measured: 1-month after the intervention
Interpersonal Closeness (Questionnaire)
Inclusion of Other in Self Scale, Aron, Aron, \& Smollan, 1992. Both partners' self-reports of interpersonal closeness.
Measured: 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)
Reis et al., 2003.Both partners' self-reports on Perceived Partner Responsiveness.
Measured: 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)
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.
Measured: 1-month after the intervention
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.
Measured: 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)
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.
Measured: 1-month after the intervention
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.
Measured: 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)
Both partners report on partner's invalidation behavior, i.e., self-report for the partner, and other-report for the individual with chronic pain.
Measured: 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)
- (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.
Measured: 1-month after the intervention
Self- and Other-Oriented Distress (Questionnaire)
Batson, Fultz, \& Schoendrade, 1987. Both partners' self-report of self- and other-oriented distress.
Measured: 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)
Both partners' report on individual with chronic pain's emotional expression.
Measured: 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)
Both partners' report on individual with chronic pain's pain expression.
Measured: 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)
Both partners' report on their perceptions of division of workload and collaboration during household tasks.
Measured: After household tasks (approx. 35 - 45 mins. after intervention)
Satisfaction with the discussion (Questionnaire)
Both partners' report on their satisfaction with the discussion.
Measured: After discussion (approx. 15 mins. after intervention)
Satisfaction with household tasks
Both partners' report
Measured: After household tasks (approx. 35 - 45 mins. after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelia Corley, Wayne State University
- Investigators
- Angelia M Corley, M.A., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859545
- Sponsor's protocol ID
- ACorley
- Acronym
- SUPER
- Status last verified
- Apr 2019
- First submitted
- 1 Aug 2016
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Understand Pain Experiences in Relationships
- ClinicalTrials.gov ID
- NCT02859545
- Acronym / sponsor ID
- SUPER / ACorley
- Conditions
- Chronic Pain
- Keywords
- chronic pain, pain, validation, couples, romantic relationships, emotional validation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 9 Aug 2016 (estimated)
- 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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Validation Training | Experimental | Behavioral: Emotional Validation Training for Romantic PartnersIn this arm, the romantic partner of the individual with chronic pain receives training on how to validate which is provided by the research assistant. |
| Education Training | Placebo comparator | Behavioral: Chronic Pain Education Training for Romantic PartnersIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| Emotional Validation Training for Romantic PartnersAlso: ValidationIn 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. | Behavioural | Validation Training |
| Chronic Pain Education Training for Romantic PartnersAlso: EducationIn 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. | Behavioural | Education Training |
Primary outcome
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.
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.
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.
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.
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.
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.
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
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
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
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
15 secondary outcomes
Relationship Satisfaction (Questionnaire)
Time frame: 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
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
Pain Intensity (Questionnaire)
Time frame: 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
Close other responses to pain and partner support (Questionnaire)
Time frame: 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
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
Ambivalence about emotional expression measured by Holding Back Scale (Questionnaire)
Time frame: 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)
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
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)
Perceived Division of Workload and Collaboration (Questionnaire)
Time frame: After household tasks (approx. 35 - 45 mins. after intervention)
Satisfaction with the discussion (Questionnaire)
Time frame: After discussion (approx. 15 mins. after intervention)
Satisfaction with household tasks
Time frame: After household tasks (approx. 35 - 45 mins. after intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
The Intervention Effect of Exercise on Lumbar Multifidus Muscle Injuries
Chronic Non-specific Low Back Pain, Lumbar Multifidus Muscle Injury
Not yet recruiting
Acceptance and Commitment Therapy Plus Physiotherapy for Chronic Low Back Pain
Low Back Pain
Not yet recruiting
Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
Chronic Low Back Pain
Recruiting
Healing Track Clinical Trial
Chronic Back Pain
Active, not recruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
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.
Angelia M Corley, M.A. principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional Validation Training for Romantic Partners and Chronic Pain Education Training for Romantic Partners in people with Chronic Pain, run by Wayne State University 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 23 Apr 2019. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain Behavior (Behavioral coding) (time frame: During lab visit, during household tasks conducted in the laboratory, approx. 15 - 35 mins. after partner training (intervention)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2019.