Clinical trial NCT02316288: Development of a Couple-based Mindfulness Intervention for Chronic Pain
Official title: Preliminary Test of an Integrative Intervention to Alleviate Chronic Pain and Improve Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2014-12-12
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Depressive Symptoms from Baseline to 1-month Followup
timeFrame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
measure: Change in Pain Intensity
timeFrame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
measure: Change in Pain Quality
timeFrame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
measure: Change in Quality of Life
timeFrame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
measure: Change in Relationship Satisfaction
timeFrame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
measure: Change in Sleep Quality
timeFrame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
measure: Change in Perceived Improvement
timeFrame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Secondary outcomes:
measure: Change in Acceptance of Chronic Pain
timeFrame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
measure: Change in Anxiety and Catastrophizing about Pain
timeFrame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
measure: Change in Mindfulness
timeFrame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
measure: Change in Values-Based Action
timeFrame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
measure: Change in Dispositional Empathy
timeFrame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
measure: Change in Emotional Expression
timeFrame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
measure: Change in Emotional Validation and Invalidation
timeFrame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
measure: Change in Partner-perceived Empathy
timeFrame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Other outcomes:
measure: Treatment Credibility
timeFrame: Baseline
measure: Therapist Adherence
timeFrame: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
measure: Therapy Homework Compliance
timeFrame: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
measure: Therapy Session Satisfaction
timeFrame: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
measure: Intent to Complete Therapy Homework
timeFrame: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
measure: Adverse Events
timeFrame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: Wayne State University
name: Annmarie Cano, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: