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Completed

NCT Number: NCT02316288

Development of a Couple-based Mindfulness Intervention for Chronic Pain

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wayne State University

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

  • 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

Treatment and study plan

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.

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.

Primary outcomes

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

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

    Beck Depression Inventory-II

  2. Change in Pain Intensity

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

    Visual Rating Scale, Multidimensional Pain Inventory, Brief Pain Inventory

  3. Change in Pain Quality

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

    McGill Pain Questionnaire

  4. Change in Quality of Life

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

    Satisfaction with Life Scale

  5. Change in Relationship Satisfaction

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

    Dyadic Adjustment Scale; Dyadic Adjustment Scale-7

  6. Change in Sleep Quality

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

    PROMIS Sleep Disturbance and Sleep-related Impairment Scales

  7. Change in Perceived Improvement

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

    Patient Global Impression of Change

Secondary outcomes

  1. Change in Acceptance of Chronic Pain

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

    Chronic Pain Acceptance Questionnaire (baseline, post-treatment, followup); Chronic Pain Acceptance Chronic Pain Acceptance Questionnaire

  2. Change in Anxiety and Catastrophizing about Pain

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

    Pain Anxiety Symptoms Scale, Pain Catastrophizing Scale (baseline, post-treatment, followup); Pain Catastrophizing Scale-Shortened Version (weekly)

  3. Change in Mindfulness

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

    Five Facet Mindfulness Scale

  4. Change in Values-Based Action

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

    Chronic Pain Values Inventory

  5. Change in Dispositional Empathy

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

    Interpersonal Reactivity Index

  6. Change in Emotional Expression

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

    Ambivalence Over Emotional Expression Questionnaire, Holding Back Scale

  7. Change in Emotional Validation and Invalidation

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

    Coded from Couple Discussion Task

  8. Change in Partner-perceived Empathy

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

    Perceived Partner Responsiveness Scale

Other outcomes

  1. Treatment Credibility

    Time frame: Baseline

    Credibility of Treatment Scale

  2. Therapist Adherence

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

    audio recordings of sessions

  3. Therapy Homework Compliance

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

    Homework Rating Scale and time spend completing homework

  4. Therapy Session Satisfaction

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

    Participants' satisfaction with session

  5. Intent to Complete Therapy Homework

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

    Participants' intention to complete homework

  6. Adverse Events

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

    Adverse event data will be collected and reported

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Preliminary Test of an Integrative Intervention to Alleviate Chronic Pain and Improve Quality of Life

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 12, 2014
Registry last updated
May 15, 2017

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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