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Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy

4. august 2014 opdateret af: Eric Garland, Florida State University

Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy: Exploration of Cognitive, Affective, and Physiological Mechanisms

Persons suffering from chronic pain who are treated with long-term opioid therapy are at risk of misusing prescription opioids and developing opioid addiction. Moreover, long-term use of opioids may result in hyperalgesia, which exacerbates opioid craving and consumption. Mindfulness interventions have been shown reduce chronic pain symptoms, addictive processes, and substance use. The investigators hypothesize that relative to a support group control condition, participation in a novel mindfulness-oriented cognitive intervention, Mindfulness-Oriented Recovery Enhancement (MORE), will result in improved well-being and decreased pain, opioid craving, and opioid misuse behaviors among chronic pain patients receiving opioid therapy.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Few behavioral treatments target the cognitive-affective mediators of opioid misuse and addiction in chronic pain patients. As such, novel, multimodal interventions are needed to effectively target key mechanisms in the risk chain from chronic pain to opioid misuse and addiction. The secondary aim of this study is to explore possible cognitive, affective, and psychophysiological mediators of intervention effects on pain, opioid craving, opioid misuse behaviors, and well-being.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

115

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Florida
      • Tallahassee, Florida, Forenede Stater, 32306-2570
        • FSU College of Social Work

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • chronic pain diagnosis (ICD-9 diagnoses 338.xx)
  • treatment with prescription opioids for > 3 months

Exclusion Criteria:

  • prior mindfulness training
  • persons who are experiencing acute opioid withdrawal
  • suicidal ideation
  • psychosis

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: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Mindfulness-orienteret Recovery Enhancement
Adfærdsmæssigt: Mindfulness-Oriented Recovery Enhancement
MORE is a multimodal, dual-process group intervention involving mindfulness training, cognitive restructuring, and positive emotion induction. MORE consists of eight, weekly, two-hour group sessions led by a trained therapist.
Aktiv komparator: Conventional Support Group (SG)
Adfærdsmæssigt: Conventional Support Group (SG)
The control arm will participate in a time-matched, conventional SG led by a Master's level therapist, discussing topics pertinent to chronic pain and opioid misuse. The SG format is adapted from the support group detailed in the evidence-based, Matrix Intensive Outpatient Treatment manual. The SG consists of eight, weekly, two-hour sessions.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain severity, pain functional interference
Tidsramme: Baseline, immediately following treatment, and at 3 month follow-up
Change in pain severity, functional interference, and relief from pain treatments measured on the Brief Pain Inventory-Short Form.
Baseline, immediately following treatment, and at 3 month follow-up
Opioid craving
Tidsramme: Baseline, immediately following treatment, and at 3 month follow-up
Change in opioid craving as measured by the Obsessive-Compulsive Drug Use Scale and a single-item measure of instantaneous craving.
Baseline, immediately following treatment, and at 3 month follow-up
Opioid misuse behaviors
Tidsramme: Baseline, immediately following treatment, and at 3 month follow-up
Change in opioid misuse behaviors as measured by the Current Opioid Misuse Measure
Baseline, immediately following treatment, and at 3 month follow-up
Well-being
Tidsramme: Baseline, immediately following treatment, and at 3 month follow-up
Change in well-being as measured by the WHO-5
Baseline, immediately following treatment, and at 3 month follow-up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Attentional bias
Tidsramme: Baseline and immediately following treatment
Change in attentional bias as measured by a dot probe task
Baseline and immediately following treatment
Psychophysiological cue-reactivity
Tidsramme: Baseline and immediately following treatment
Change in psychophysiological cue-reactivity
Baseline and immediately following treatment
Emotional response inhibition
Tidsramme: Baseline and immediately following treatment
Change in emotional response inhibition
Baseline and immediately following treatment
Pain coping strategies
Tidsramme: Baseline, intervention midpoint, and immediately following treatment
Change in reinterpretation of pain sensations, catastrophizing, and suppression.
Baseline, intervention midpoint, and immediately following treatment
Anhedonia
Tidsramme: Baseline and immediately following treatment
Change in anhedonia
Baseline and immediately following treatment
Fear of pain
Tidsramme: Baseline and immediately following treatment
Change in fear of pain
Baseline and immediately following treatment
Mindfulness
Tidsramme: Baseline, intervention midpoint, and immediately following treatment
Change in mindfulness measured by the Five-Facet Mindfulness Questionnaire and the Toronto Mindfulness Scale
Baseline, intervention midpoint, and immediately following treatment
Positive reappraisal
Tidsramme: Baseline and immediately following treatment
Change in positive reappraisal
Baseline and immediately following treatment

Samarbejdspartnere og efterforskere

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

Sponsor

Florida State University

Samarbejdspartnere

National Institute on Drug Abuse (NIDA)
Fahs Beck Fund for Research and Experimentation

Efterforskere

  • Ledende efterforsker: Eric L Garland, PhD, Florida State 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. oktober 2011

Primær færdiggørelse (Faktiske)

1. juli 2013

Studieafslutning (Faktiske)

1. juli 2013

Datoer for studieregistrering

Først indsendt

4. januar 2012

Først indsendt, der opfyldte QC-kriterier

5. januar 2012

Først opslået (Skøn)

6. januar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. august 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. august 2014

Sidst verificeret

1. august 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DA032517-01
  • R03DA032517 (U.S. NIH-bevilling/kontrakt)

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 Kronisk smerte

Kliniske forsøg med Mindfulness-Oriented Recovery Enhancement

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Betingelser

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