Development of a Couple-based Mindfulness Intervention for Chronic Pain

NCT02316288 | Completed DMC

• 1 other identifier: 1R21AT007939-01A1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• Change in Depressive Symptoms from Baseline to 1-month Followup

  Beck Depression Inventory-II

  Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

• Change in Pain Intensity

  Visual Rating Scale, Multidimensional Pain Inventory, Brief Pain Inventory

  Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

• Change in Pain Quality

  McGill Pain Questionnaire

  Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

• Change in Quality of Life

  Satisfaction with Life Scale

  Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

• Change in Relationship Satisfaction

  Dyadic Adjustment Scale; Dyadic Adjustment Scale-7

  Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

• Change in Sleep Quality

  PROMIS Sleep Disturbance and Sleep-related Impairment Scales

  Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

• Change in Perceived Improvement

  Patient Global Impression of Change

  Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

Secondary Outcomes (8)

• Change in Acceptance of Chronic Pain

  Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

• Change in Anxiety and Catastrophizing about Pain

  Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

• Change in Mindfulness

  Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

• Change in Values-Based Action

  Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

• Change in Dispositional Empathy

  Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

Other Outcomes (6)

• Treatment Credibility

  Baseline

• Therapist Adherence

  Participants will be followed for the duration of the intervention, an expected average of 6 weeks

• Therapy Homework Compliance

  Participants will be followed for the duration of the intervention, an expected average of 6 weeks

Study Arms (2)

Therapy

EXPERIMENTAL

Mindfulness and Acceptance Therapy

Behavioral: Mindfulness and Acceptance Therapy

Education

ACTIVE COMPARATOR

Health Education

Behavioral: Health Education

Interventions

Mindfulness and Acceptance Therapy 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.

Therapy

Health Education 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.

Education

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Wayne State University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Wayne State University

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Annmarie Cano, Ph.D.

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor; Associate Chair

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 12, 2014
• Study Start: December 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 15, 2017

Record last verified: 2017-05

Locations

US (1)