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Development of a Couple-based Mindfulness Intervention for Chronic Pain

Not Applicable
Completed
Conditions
Chronic Pain
Interventions
Behavioral: Health Education
Behavioral: Mindfulness and Acceptance Therapy
Registration Number
NCT02316288
Lead Sponsor
Wayne State University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
48
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
EducationHealth EducationHealth Education
TherapyMindfulness and Acceptance TherapyMindfulness and Acceptance Therapy
Primary Outcome Measures
NameTimeMethod
Change in Quality of LifeParticipants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

Satisfaction with Life Scale

Change in Relationship SatisfactionParticipants 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

Change in Depressive Symptoms from Baseline to 1-month FollowupParticipants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

Beck Depression Inventory-II

Change in Sleep QualityParticipants 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

Change in Pain QualityParticipants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

McGill Pain Questionnaire

Change in Pain IntensityParticipants 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

Change in Perceived ImprovementParticipants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

Patient Global Impression of Change

Secondary Outcome Measures
NameTimeMethod
Change in Anxiety and Catastrophizing about PainParticipants 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)

Change in Dispositional EmpathyParticipants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

Interpersonal Reactivity Index

Change in Emotional ExpressionParticipants 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

Change in Emotional Validation and InvalidationParticipants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

Coded from Couple Discussion Task

Change in Partner-perceived EmpathyParticipants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

Perceived Partner Responsiveness Scale

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

Five Facet Mindfulness Scale

Change in Acceptance of Chronic PainParticipants 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

Change in Values-Based ActionParticipants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks

Chronic Pain Values Inventory

Trial Locations

Locations (1)

Wayne State University

🇺🇸

Detroit, Michigan, United States

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