- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03882125
Mindfulness-Based Relapse Prevention for Methadone Maintenance
18. mars 2019 oppdatert av: Sarah Bowen, Pacific University
Mindfulness-Based Relapse Prevention for Methadone Maintenance: A Feasibility Trial
The current study was designed to inform protocol adaptation, and to evaluate the feasibility, acceptability, and preliminary efficacy of a mindfulness-based intervention for methadone maintenance clients.
Adults (N=15) were recruited from a methadone clinic to participate in a 6-week mindfulness course.
Indices of feasibility, including recruitment, retention, data from focus groups and course satisfaction surveys, supported feasibility of the intervention.
Outcome measures were self-report, and included depression, craving, PTSD symptoms, and experiential avoidance, and were assessed at baseline, postcourse, and 1-month follow-up.
Data were analyzed using qualitative and quantitative approaches.
Mean scores on all primary outcomes changed in the expected direction at both postcourse and 1-month follow-up assessment, although only depression and experiential avoidance reached significance.
Results support feasibility and acceptability, and provide preliminary data on outcomes for future trials of mindfulness-based approaches within this client population.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
As rates of opiate misuse rise in the United States, there areso do significant associated health, and financial consequences to afflicted individuals, their families, and society at large.
Methadone Maintenance Therapy (MMT) is one evidence-based approach to treating individuals with opiate addiction, yet supplemental psychosocial treatment to support this approach is lacking.
Mindfulness-Based Relapse Prevention (MBRP) has shown to be efficacious in various substance use populations, but has yet to be assessed with MMT clients.
The current study was designed to inform protocol adaptation for to MMT clients, and to evaluate the feasibility, acceptability, and preliminary efficacy of a MBRP for this population.
The sample consisted of adults (N=15) recruited from a methadone clinic to participate in a 6-week MBRP course.
Indices of feasibility, including recruitment, retention, data from focus groups and course satisfaction surveys, supported feasibility of the intervention.
Outcome measures were self-report, and included self-compassion, depression, craving, PTSD symptoms, and experiential avoidance, and were assessed at baseline, postcourse, and 1-month follow-up.
Data were analyzed using qualitative and quantitative approaches.
Mean scores on all primary outcomes changed in the expected direction at both postcourse and 1-month follow-up assessment, although only depression and experiential avoidance reached significance.
Results from this initial pilot support feasibility and acceptability, and provide preliminary data on outcomes for future trials of mindfulness-based approaches within the MMT community.
Studietype
Intervensjonell
Registrering (Faktiske)
14
Fase
- Ikke aktuelt
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 til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Clearance from clinic staff
- Currently enrolled in a methadone maintenance program
- Agree to complete assessment questionnaires and attend treatment sessions
- Fluent in English
Exclusion Criteria:
- Indication of active psychosis
- Participation in past mindfulness-based relapse prevention group
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: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Mindfulness
Assigned to a 6-week mindfulness-based relapse prevention course
|
Psychosocial intervention integrating mindfulness practice and cognitive behavioral relapse prevention approaches
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Acceptability - Satisfaction with the Course
Tidsramme: post course (6 weeks)
|
Satisfaction with the course will be assessed using the Overall Course Satisfaction Survey, items #1-4 (Bowen, Chawla, & Marlatt, 2010).
This is a self-report questionnaire, the first 4 items of which are open-ended questions assessing satisfaction with the course, barriers to learning, and perceived helpfulness.
|
post course (6 weeks)
|
Acceptability - Enactment of Learned Skills
Tidsramme: post course (6 weeks)
|
Enactment will be assessed using the Overall Course Satisfaction Survey, items #5-7 (Bowen, Chawla, & Marlatt, 2010).
This is a self-report questionnaire, the last 3 questions of which are 10-point Likert-type items, and assess importance of skills and likelihood of implementing them into daily life after the course ends.
Higher scores indicate higher perceived importance and likelihood.
|
post course (6 weeks)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Depression
Tidsramme: 1 month
|
Depression symptoms will be assessed using the Beck Depression Inventory-II, a 21-item self report measure.
Items are summed for a total score ranging from 0-63.
A score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
|
1 month
|
Anxiety
Tidsramme: 1 month
|
Anxiety symptoms will be assessed using the Beck Anxiety Inventory, a 21-item self report measure.
Items are summed for a total score that can range between 0 and 63 points.
A total score of 0 - 7 is interpreted as a Minimal anxiety, 8 - 15 as Mild, 16 - 25 as Moderate, and 26 - 63 as Severe.
|
1 month
|
Craving
Tidsramme: 1 month
|
Craving for substances will be assessed using the Penn Alcohol Craving Scale, a five-item Likert-scaled measure assessing frequency, intensity, duration, and overall levels of craving, adapted to include both alcohol and drugs.
Each question is scaled from 0 to 6. Sum scores range from 0-30, with greater scores indicating higher craving.
|
1 month
|
Trauma symptoms
Tidsramme: 1 month
|
PTSD symptoms will be assessed using the Post-Traumatic Stress Disorder Checklist-Civilian (PCL-C), which measures presence and severity of trauma symptoms using 16-item Likert-scaled questionnaire.
|
1 month
|
Experiential avoidance
Tidsramme: 1 month
|
The Acceptance and Action Questionnaire (AAQ) is a widely used measure of experiential avoidance and psychological inflexibility consisting of nine Likert-scaled items, answer options ranging from 1 (never true) to 7 (always true).
High scores reflect greater experiential avoidance and immobility, while low scores reflect greater acceptance and action.
|
1 month
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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 (Faktiske)
15. februar 2015
Primær fullføring (Faktiske)
27. juni 2015
Studiet fullført (Faktiske)
27. juni 2015
Datoer for studieregistrering
Først innsendt
3. april 2017
Først innsendt som oppfylte QC-kriteriene
18. mars 2019
Først lagt ut (Faktiske)
20. mars 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. mars 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. mars 2019
Sist bekreftet
1. mars 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MBRP for MMT
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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