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Development of a Couple-based Mindfulness Intervention for Chronic Pain

11 mei 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

48

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Michigan
      • Detroit, Michigan, Verenigde Staten, 48202
        • Wayne State University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

21 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Therapy
Mindfulness and Acceptance Therapy
Gedragsmatig: 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.
Actieve vergelijker: Education
Health Education
Gedragsmatig: Health 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Depressive Symptoms from Baseline to 1-month Followup
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Acceptance of Chronic Pain
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Treatment Credibility
Tijdsspanne: Baseline
Credibility of Treatment Scale
Baseline
Therapist Adherence
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Wayne State University

Medewerkers

National Center for Complementary and Integrative Health (NCCIH)

Onderzoekers

  • Hoofdonderzoeker: Annmarie Cano, Ph.D., Wayne State University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2014

Primaire voltooiing (Werkelijk)

1 mei 2017

Studie voltooiing (Werkelijk)

1 mei 2017

Studieregistratiedata

Eerst ingediend

4 december 2014

Eerst ingediend dat voldeed aan de QC-criteria

9 december 2014

Eerst geplaatst (Schatting)

12 december 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 mei 2017

Laatste update ingediend die voldeed aan QC-criteria

11 mei 2017

Laatst geverifieerd

1 mei 2017

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 1R21AT007939-01A1 (Subsidie/contract van de Amerikaanse NIH)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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