- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03882125
Mindfulness-Based Relapse Prevention for Methadone Maintenance
18. marts 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
14
Fase
- Ikke anvendelig
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 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Mindfulness
Assigned to a 6-week mindfulness-based relapse prevention course
|
Psychosocial intervention integrating mindfulness practice and cognitive behavioral relapse prevention approaches
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 (Faktiske)
15. februar 2015
Primær færdiggørelse (Faktiske)
27. juni 2015
Studieafslutning (Faktiske)
27. juni 2015
Datoer for studieregistrering
Først indsendt
3. april 2017
Først indsendt, der opfyldte QC-kriterier
18. marts 2019
Først opslået (Faktiske)
20. marts 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. marts 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. marts 2019
Sidst verificeret
1. marts 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MBRP for MMT
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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