Chronic Pain
Conditions
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.
Interventions
BEHAVIORALMindfulness and Acceptance Therapy
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.
BEHAVIORALHealth Education
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.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Relationship Satisfaction | 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 Quality of Life | 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 Pain Intensity | 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 Pain Quality | Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks | McGill Pain Questionnaire |
| Change in Perceived Improvement | Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks | Patient Global Impression of Change |
| Change in Sleep Quality | 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 Depressive Symptoms from Baseline to 1-month Followup | Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks | Beck Depression Inventory-II |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Partner-perceived Empathy | Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks | Perceived Partner Responsiveness Scale |
| Change in Dispositional Empathy | Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks | Interpersonal Reactivity Index |
| 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 | Chronic Pain Acceptance Questionnaire (baseline, post-treatment, followup); Chronic Pain Acceptance Chronic Pain Acceptance Questionnaire |
| 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 | Pain Anxiety Symptoms Scale, Pain Catastrophizing Scale (baseline, post-treatment, followup); Pain Catastrophizing Scale-Shortened Version (weekly) |
| Change in Mindfulness | Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks | Five Facet Mindfulness Scale |
| Change in Values-Based Action | Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks | Chronic Pain Values Inventory |
| Change in Emotional Expression | 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 |
| 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 | Coded from Couple Discussion Task |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment Credibility | Baseline | Credibility of Treatment Scale |
| Adverse Events | 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 |
| Intent to Complete Therapy Homework | Participants will be followed for the duration of the intervention, an expected average of 6 weeks | Participants' intention to complete homework |
| Therapy Session Satisfaction | Participants will be followed for the duration of the intervention, an expected average of 6 weeks | Participants' satisfaction with session |
| Therapy Homework Compliance | Participants will be followed for the duration of the intervention, an expected average of 6 weeks | Homework Rating Scale and time spend completing homework |
| Therapist Adherence | Participants will be followed for the duration of the intervention, an expected average of 6 weeks | audio recordings of sessions |
Countries
United States
Outcome results
None listed