- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02316288
Development of a Couple-based Mindfulness Intervention for Chronic Pain
May 11, 2017 updated by: Annmarie Cano, Wayne State University
Preliminary Test of an Integrative Intervention to Alleviate Chronic Pain and Improve Quality of Life
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Michigan
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Detroit, Michigan, United States, 48202
- Wayne State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Therapy
Mindfulness 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.
|
Active Comparator: Education
Health Education
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
|
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
|
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
|
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
|
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
|
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
|
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
Time Frame: 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
|
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
Time Frame: 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)
|
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
Change in Mindfulness
Time Frame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
Time Frame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
Time Frame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
Time Frame: 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
|
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
Time Frame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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
Time Frame: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
Perceived Partner Responsiveness Scale
|
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Credibility
Time Frame: Baseline
|
Credibility of Treatment Scale
|
Baseline
|
Therapist Adherence
Time Frame: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
|
audio recordings of sessions
|
Participants will be followed for the duration of the intervention, an expected average of 6 weeks
|
Therapy Homework Compliance
Time Frame: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
|
Homework Rating Scale and time spend completing homework
|
Participants will be followed for the duration of the intervention, an expected average of 6 weeks
|
Therapy Session Satisfaction
Time Frame: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
|
Participants' satisfaction with session
|
Participants will be followed for the duration of the intervention, an expected average of 6 weeks
|
Intent to Complete Therapy Homework
Time Frame: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
|
Participants' intention to complete homework
|
Participants will be followed for the duration of the intervention, an expected average of 6 weeks
|
Adverse Events
Time Frame: 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
|
Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Annmarie Cano, Ph.D., Wayne State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
May 1, 2017
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
December 4, 2014
First Submitted That Met QC Criteria
December 9, 2014
First Posted (Estimate)
December 12, 2014
Study Record Updates
Last Update Posted (Actual)
May 15, 2017
Last Update Submitted That Met QC Criteria
May 11, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21AT007939-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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