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The Effects of Mindfulness-Based Stress Reduction on Attention and Pain-related Symptoms in Chronic Pain Patients

12. februar 2014 opdateret af: Nicholas Cepeda, York University

The Effects of Mindfulness-Based Stress Reduction on Attention and Pain-related Symptoms in Chronic Pain Patients: A Randomized Controlled Trial

The main purpose of this study is to determine the degree to which Mindfulness-Based Stress Reduction, a group-based psychological therapy that includes mindfulness meditation exercises, reduces depression, anxiety, stress, pain intensity, and interference of pain with daily life among adult chronic pain patients.

The second purpose is to examine the role of attention in improving psychological and physical health for chronic pain patients.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

49

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Adult chronic pain patients who are proficient in English
  • Capable of interacting with others in a group setting
  • Capable of working with a computer

Exclusion Criteria:

  • Alcohol or drug abuse (past history is acceptable as long as their situation has been stable for at least 3 months)
  • Psychiatric psychosis (patients who have a past history of schizophrenia are eligible as long as they are currently stable)
  • Current major depressive disorder
  • Current severe social phobia
  • At immediate risk for suicide
  • Cerebral lesions or tumors (unless medically and cognitively stable)
  • Neurological disease
  • Medically unstable
  • Cognitively unstable
  • Previously participated in a mindfulness meditation program

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Ventelistekontrol
Aktiv komparator: Mindfulness-baseret stressreduktion
Adfærdsmæssigt: Mindfulness-Based Stress Reduction
An 8-week structured group program that was developed to improve psychological and physical symptoms associated with pain. It incorporates a variety of mindfulness meditation exercises including mindful yoga, sitting meditation, and body scan to facilitate attention, acceptance, and awareness of one's experiences.
Andre navne:
  • MBSR

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain disability and Attention
Tidsramme: Baseline, immediately following treatment, and at 3 months follow up

Change in pain disability assessed by the Pain Disability Index (PDI).

Change in attention assessed by an adapted version of the Change Blindness Task
Baseline, immediately following treatment, and at 3 months follow up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Depression
Tidsramme: Baseline, immediately following treatment, and at 3 months follow up
Change in depression assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)
Baseline, immediately following treatment, and at 3 months follow up
Anxiety
Tidsramme: Baseline, immediately following treatment, and at 3 months follow up
Change in anxiety assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)
Baseline, immediately following treatment, and at 3 months follow up
Stress
Tidsramme: Baseline, immediately following treatment, and at 3 months follow up
Change in stress assessed by the Depression, Anxiety, and Stress Scale 21 (DASS-21)
Baseline, immediately following treatment, and at 3 months follow up
Mindfulness
Tidsramme: Baseline, immediately following treatment, and at 3 months follow up
Change in mindfulness assessed by the Five Facet Mindfulness Questionnaire (FFMQ) and Mindful Attention Awareness Scale (MAAS)
Baseline, immediately following treatment, and at 3 months follow up
Acceptance
Tidsramme: Baseline, immediately following treatment, and at 3 months follow up
Change in acceptance assessed by the Chronic Pain Acceptance Questionnaire (CPAQ)
Baseline, immediately following treatment, and at 3 months follow up
Pain Intensity
Tidsramme: Baseline, immediately following treatment, and at 3 months follow up
Change in pain intensity assessed by the Short-form McGill Pain Questionnaire (SF-MPQ-2).
Baseline, immediately following treatment, and at 3 months follow up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

York University

Samarbejdspartnere

Mount Sinai Hospital, Canada
Wasser Pain Management Centre
Rasch Foundation

Efterforskere

  • Ledende efterforsker: Allan Gordon, MD, Mount Sinai Hospital
  • Ledende efterforsker: Nicholas Cepeda, PhD, York University
  • Studieleder: Denise Paneduro, PhD student, York University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2011

Primær færdiggørelse (Faktiske)

1. november 2013

Studieafslutning (Faktiske)

1. november 2013

Datoer for studieregistrering

Først indsendt

5. december 2011

Først indsendt, der opfyldte QC-kriterier

5. december 2011

Først opslået (Skøn)

7. december 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

13. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. februar 2014

Sidst verificeret

1. februar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FWA00003852

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Smerte

Kliniske forsøg med Mindfulness-Based Stress Reduction

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Vietnam

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner