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Development of a Couple-based Mindfulness Intervention for Chronic Pain

11 maggio 2017 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

48

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Michigan
      • Detroit, Michigan, Stati Uniti, 48202
        • Wayne State University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

21 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Therapy
Mindfulness and Acceptance Therapy
Comportamentale: 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.
Comparatore attivo: Education
Health Education
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Depressive Symptoms from Baseline to 1-month Followup
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Acceptance of Chronic Pain
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Treatment Credibility
Lasso di tempo: Baseline
Credibility of Treatment Scale
Baseline
Therapist Adherence
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Wayne State University

Collaboratori

National Center for Complementary and Integrative Health (NCCIH)

Investigatori

  • Investigatore principale: Annmarie Cano, Ph.D., Wayne State University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2014

Completamento primario (Effettivo)

1 maggio 2017

Completamento dello studio (Effettivo)

1 maggio 2017

Date di iscrizione allo studio

Primo inviato

4 dicembre 2014

Primo inviato che soddisfa i criteri di controllo qualità

9 dicembre 2014

Primo Inserito (Stima)

12 dicembre 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 maggio 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 maggio 2017

Ultimo verificato

1 maggio 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1R21AT007939-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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