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Development of a Couple-based Mindfulness Intervention for Chronic Pain

11 mai 2017 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

48

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Michigan
      • Detroit, Michigan, États-Unis, 48202
        • Wayne State University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

21 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Therapy
Mindfulness and Acceptance Therapy
Comportemental: 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.
Comparateur actif: Education
Health Education
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Depressive Symptoms from Baseline to 1-month Followup
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Acceptance of Chronic Pain
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Treatment Credibility
Délai: Baseline
Credibility of Treatment Scale
Baseline
Therapist Adherence
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Wayne State University

Collaborateurs

National Center for Complementary and Integrative Health (NCCIH)

Les enquêteurs

  • Chercheur principal: Annmarie Cano, Ph.D., Wayne State University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 décembre 2014

Achèvement primaire (Réel)

1 mai 2017

Achèvement de l'étude (Réel)

1 mai 2017

Dates d'inscription aux études

Première soumission

4 décembre 2014

Première soumission répondant aux critères de contrôle qualité

9 décembre 2014

Première publication (Estimation)

12 décembre 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 mai 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

11 mai 2017

Dernière vérification

1 mai 2017

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 1R21AT007939-01A1 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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