Development of a Couple-based Mindfulness Intervention for Chronic Pain
11. Mai 2017 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
48
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Michigan
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Detroit, Michigan, Vereinigte Staaten, 48202
- Wayne State University
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
21 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Therapy
Mindfulness and Acceptance Therapy
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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.
|
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Aktiver Komparator: 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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Depressive Symptoms from Baseline to 1-month Followup
Zeitfenster: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Beck Depression Inventory-II
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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Change in Pain Intensity
Zeitfenster: 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
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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Change in Pain Quality
Zeitfenster: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
McGill Pain Questionnaire
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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Change in Quality of Life
Zeitfenster: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
Satisfaction with Life Scale
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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Change in Relationship Satisfaction
Zeitfenster: 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
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
|
Change in Sleep Quality
Zeitfenster: 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
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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Change in Perceived Improvement
Zeitfenster: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
Patient Global Impression of Change
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Acceptance of Chronic Pain
Zeitfenster: 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
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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Change in Anxiety and Catastrophizing about Pain
Zeitfenster: 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)
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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Change in Mindfulness
Zeitfenster: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Five Facet Mindfulness Scale
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
|
Change in Values-Based Action
Zeitfenster: 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
Zeitfenster: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
Interpersonal Reactivity Index
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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Change in Emotional Expression
Zeitfenster: 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
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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
Zeitfenster: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
Coded from Couple Discussion Task
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
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Change in Partner-perceived Empathy
Zeitfenster: Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
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Perceived Partner Responsiveness Scale
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Participants will be followed for the duration of the intervention and followup period, an expected average of 10 weeks
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Treatment Credibility
Zeitfenster: Baseline
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Credibility of Treatment Scale
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Baseline
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Therapist Adherence
Zeitfenster: Participants will be followed for the duration of the intervention, an expected average of 6 weeks
|
audio recordings of sessions
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Participants will be followed for the duration of the intervention, an expected average of 6 weeks
|
|
Therapy Homework Compliance
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Annmarie Cano, Ph.D., Wayne State University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Dezember 2014
Primärer Abschluss (Tatsächlich)
1. Mai 2017
Studienabschluss (Tatsächlich)
1. Mai 2017
Studienanmeldedaten
Zuerst eingereicht
4. Dezember 2014
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Dezember 2014
Zuerst gepostet (Schätzen)
12. Dezember 2014
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
15. Mai 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
11. Mai 2017
Zuletzt verifiziert
1. Mai 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 1R21AT007939-01A1 (US NIH Stipendium/Vertrag)
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