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Development of a Couple-based Mindfulness Intervention for Chronic Pain

11 maj 2017 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

48

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Michigan
      • Detroit, Michigan, Förenta staterna, 48202
        • Wayne State University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

21 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Therapy
Mindfulness and Acceptance Therapy
Beteende: 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.
Aktiv komparator: Education
Health Education
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Depressive Symptoms from Baseline to 1-month Followup
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Acceptance of Chronic Pain
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Treatment Credibility
Tidsram: Baseline
Credibility of Treatment Scale
Baseline
Therapist Adherence
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Wayne State University

Samarbetspartners

National Center for Complementary and Integrative Health (NCCIH)

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 december 2014

Primärt slutförande (Faktisk)

1 maj 2017

Avslutad studie (Faktisk)

1 maj 2017

Studieregistreringsdatum

Först inskickad

4 december 2014

Först inskickad som uppfyllde QC-kriterierna

9 december 2014

Första postat (Uppskatta)

12 december 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 maj 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 maj 2017

Senast verifierad

1 maj 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1R21AT007939-01A1 (U.S.S. NIH-anslag/kontrakt)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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