Study to Understand Pain Experiences in Relationships

NCT ID: NCT02859545

Last Updated: 2019-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2018-06-30

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Emotional Validation Training for Romantic Partners

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

Chronic Pain Education Training for Romantic Partners

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Validation; Education

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Angelia Corley

Graduate Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angelia M Corley, M.A.

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

Wayne State University's Relationships and Health Lab

Detroit, Michigan, United States

Countries

United States

Other Identifiers

ACorley

Identifier Type: -

Identifier Source: org_study_id