Development of a Couple-based Mindfulness Intervention for Chronic Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Mindfulness and Acceptance Therapy
* Behavioral: Health Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy<br>Mindfulness and Acceptance Therapy | Behavioral: Mindfulness and Acceptance Therapy<br>* 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.<br>|
| Active Comparator: Education<br>Health Education | Behavioral: Health Education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Acceptance of Chronic Pain | Chronic Pain Acceptance Questionnaire (baseline, post-treatment, followup); Chronic Pain Acceptance Chronic Pain Acceptance Questionnaire | 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 | Pain Anxiety Symptoms Scale, Pain Catastrophizing Scale (baseline, post-treatment, followup); Pain Catastrophizing Scale-Shortened Version (weekly) | Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks | 
| Change in Mindfulness | Five Facet Mindfulness Scale | Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks | 
| Change in Values-Based Action | Chronic Pain Values Inventory | Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks | 
| Change in Dispositional Empathy | Interpersonal Reactivity Index | Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks | 
| Change in Emotional Expression | Ambivalence Over Emotional Expression Questionnaire, Holding Back Scale | Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks | 
| Change in Emotional Validation and Invalidation | Coded from Couple Discussion Task | Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks | 
| Change in Partner-perceived Empathy | Perceived Partner Responsiveness Scale | Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks |