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Development of a Couple-based Mindfulness Intervention for Chronic Pain
NCT02316288 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Health Education
- BEHAVIORAL Mindfulness and Acceptance Therapy
Study Locations (1)
Michigan
- Wayne State University — Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2014-12 |
| Est. Completion | 2017-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02316288
The ClinicalTrials.gov registry entry for NCT02316288 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wayne State University, which has 145 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Chronic Pain appearing as the primary indexed condition, and to 2 interventions — of which Health Education is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02316288 reports 1 study location spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02316288 about?
NCT02316288 is a clinical study titled "Development of a Couple-based Mindfulness Intervention for Chronic Pain". 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...
What is the current status of trial NCT02316288?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2014-12. Estimated completion is 2017-05.
What conditions does trial NCT02316288 study?
This clinical trial studies the following conditions: Chronic Pain. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02316288?
The interventions under investigation include: Health Education (BEHAVIORAL), Mindfulness and Acceptance Therapy (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02316288?
This trial is sponsored by Wayne State University, which has 145 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02316288 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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