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Completed

NCT Number: NCT02859545

Study to Understand Pain Experiences in Relationships

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wayne State University's Relationships and Health Lab

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Emotional Validation Training for Romantic Partners

Behavioral

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

Chronic Pain Education Training for Romantic Partners

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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

Secondary outcomes

  1. Relationship Satisfaction (Questionnaire)

    Time frame: 1-month after the intervention

    Couples Satisfaction Index, Funk & Rogge, 2007. Both partners' self-reports of relationship satisfaction.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. Satisfaction with the discussion (Questionnaire)

    Time frame: After discussion (approx. 15 mins. after intervention)

    Both partners' report on their satisfaction with the discussion.

  15. Satisfaction with household tasks

    Time frame: After household tasks (approx. 35 - 45 mins. after intervention)

    Both partners' report

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Acronym: SUPER

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Aug 9, 2016
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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