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Clinical Trials/NCT02316288
NCT02316288
Completed
N/A

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

Wayne State University1 site in 1 country48 target enrollmentDecember 2014
ConditionsChronic Pain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Wayne State University
Enrollment
48
Locations
1
Primary Endpoint
Change in Quality of Life
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
May 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Annmarie Cano

Professor; Associate Chair

Wayne State University

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

Outcomes

Primary Outcomes

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

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

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

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

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

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

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

  • 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 Dispositional Empathy(Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks)
  • Change in Emotional Expression(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(Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks)
  • Change in Partner-perceived Empathy(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 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 Values-Based Action(Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks)

Study Sites (1)

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