Development of a Couple-based Mindfulness Intervention for Chronic Pain

NCT ID: NCT02316288

Last Updated: 2017-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2017-05-31

Brief Summary

Chronic pain is a costly public health problem that is associated with poor quality of life. Previous research has demonstrated extensive evidence showing that pain coping is not manifested by patients in isolation but within the context of significant relationships such as marriage. For instance, a partner may avoid or reject their partners' negative emotions about pain, provide unempathic responses to their partners' pain, or change their thoughts about pain. The patient's pain experience and the couples' relationship also have a cyclical relationship, in which both can affect each other and the overall quality of life for both partners. Currently, current clinical practice does not target both partners to alleviate pain. This is highly problematic given that a number of chronic pain patients-those with interpersonal distress-often do not complete, and thus, do not benefit fully from existing treatments. Even if treatment is completed, individuals may not maintain improvements if they return to distressed social environments that undermine individual coping efforts. Thus, it is clear that new interventions derived from integrative models of individual and dyadic coping are needed to alleviate pain and suffering in patients who are at risk for poor treatment outcomes. This research study aims to develop a novel psychological intervention aimed at couples in which one partner has chronic pain. Our central hypothesis is that a theoretically integrative intervention that improves both partners' psychological flexibility (i.e., acceptance, mindfulness, values-based action) and relational flexibility (i.e., emotional disclosure, empathic responding) skills will be feasible and valid and that it will alleviate pain and improve quality of life. This is a departure from current practice, which focuses solely on the patient's individual functioning, does not address the spouse's psychological inflexibility, and does not address relationship issues.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Therapy

Mindfulness and Acceptance Therapy

Group Type: EXPERIMENTAL

Mindfulness and Acceptance Therapy

Intervention Type: BEHAVIORAL

Couples will learn psychological flexibility skills including mindfulness, acceptance, and values-based action as well as relational flexibility skills including empathic listening and responding during weekly 1.5-hour long sessions over the course of this 6-week intervention.

Education

Health Education

Group Type: ACTIVE_COMPARATOR

Health Education

Intervention Type: BEHAVIORAL

Couples will learn about chronic pain including causes, consequences, and how to talk with their health care professionals about their pain during weekly 1.5-hour long sessions over the course of this 6-week program.

Interventions

Mindfulness and Acceptance Therapy

Couples will learn psychological flexibility skills including mindfulness, acceptance, and values-based action as well as relational flexibility skills including empathic listening and responding during weekly 1.5-hour long sessions over the course of this 6-week intervention.

Intervention Type: BEHAVIORAL

Health Education

Couples will learn about chronic pain including causes, consequences, and how to talk with their health care professionals about their pain during weekly 1.5-hour long sessions over the course of this 6-week program.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• At least one spouse with some pain interference.
• Relationship dissatisfaction.
• Both partners at least 21 years old.
• Couples must also be married or cohabitating for at least 2 years regardless of sexual orientation to participate in the study.

Exclusion Criteria

• Current suicidal or homicidal ideation or intent
• Current psychotic symptoms
• Cognitive impairment
• Malignancies (e.g., cancer) in either partner
• Current domestic violence

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Annmarie Cano

Professor; Associate Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Annmarie Cano, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

Wayne State University

Detroit, Michigan, United States

Countries

United States

Other Identifiers

1R21AT007939-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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