Mindfulness-Oriented Recovery Enhancement for Chronic Pain Patients Receiving Opioid Therapy
4. august 2014 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
115
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Florida
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Tallahassee, Florida, Forente stater, 32306-2570
- FSU College of Social Work
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Mindfulness-orientert restitusjonsforbedring
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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.
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Aktiv komparator: Conventional Support Group (SG)
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pain severity, pain functional interference
Tidsramme: Baseline, immediately following treatment, and at 3 month follow-up
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Change in pain severity, functional interference, and relief from pain treatments measured on the Brief Pain Inventory-Short Form.
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Baseline, immediately following treatment, and at 3 month follow-up
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Opioid craving
Tidsramme: Baseline, immediately following treatment, and at 3 month follow-up
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Change in opioid craving as measured by the Obsessive-Compulsive Drug Use Scale and a single-item measure of instantaneous craving.
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Baseline, immediately following treatment, and at 3 month follow-up
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Opioid misuse behaviors
Tidsramme: Baseline, immediately following treatment, and at 3 month follow-up
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Change in opioid misuse behaviors as measured by the Current Opioid Misuse Measure
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Baseline, immediately following treatment, and at 3 month follow-up
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Well-being
Tidsramme: Baseline, immediately following treatment, and at 3 month follow-up
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Change in well-being as measured by the WHO-5
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Baseline, immediately following treatment, and at 3 month follow-up
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Attentional bias
Tidsramme: Baseline and immediately following treatment
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Change in attentional bias as measured by a dot probe task
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Baseline and immediately following treatment
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Psychophysiological cue-reactivity
Tidsramme: Baseline and immediately following treatment
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Change in psychophysiological cue-reactivity
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Baseline and immediately following treatment
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Emotional response inhibition
Tidsramme: Baseline and immediately following treatment
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Change in emotional response inhibition
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Baseline and immediately following treatment
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Pain coping strategies
Tidsramme: Baseline, intervention midpoint, and immediately following treatment
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Change in reinterpretation of pain sensations, catastrophizing, and suppression.
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Baseline, intervention midpoint, and immediately following treatment
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Anhedonia
Tidsramme: Baseline and immediately following treatment
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Change in anhedonia
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Baseline and immediately following treatment
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Fear of pain
Tidsramme: Baseline and immediately following treatment
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Change in fear of pain
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Baseline and immediately following treatment
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Mindfulness
Tidsramme: Baseline, intervention midpoint, and immediately following treatment
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Change in mindfulness measured by the Five-Facet Mindfulness Questionnaire and the Toronto Mindfulness Scale
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Baseline, intervention midpoint, and immediately following treatment
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Positive reappraisal
Tidsramme: Baseline and immediately following treatment
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Change in positive reappraisal
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Baseline and immediately following treatment
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Eric L Garland, PhD, Florida State University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2011
Primær fullføring (Faktiske)
1. juli 2013
Studiet fullført (Faktiske)
1. juli 2013
Datoer for studieregistrering
Først innsendt
4. januar 2012
Først innsendt som oppfylte QC-kriteriene
5. januar 2012
Først lagt ut (Anslag)
6. januar 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
6. august 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. august 2014
Sist bekreftet
1. august 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DA032517-01
- R03DA032517 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .