Mindfulness-Based Relapse Prevention for Methadone Maintenance
18. März 2019 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
14
Phase
- Unzutreffend
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Mindfulness
Assigned to a 6-week mindfulness-based relapse prevention course
|
Psychosocial intervention integrating mindfulness practice and cognitive behavioral relapse prevention approaches
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Acceptability - Satisfaction with the Course
Zeitfenster: 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
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Depression
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
15. Februar 2015
Primärer Abschluss (Tatsächlich)
27. Juni 2015
Studienabschluss (Tatsächlich)
27. Juni 2015
Studienanmeldedaten
Zuerst eingereicht
3. April 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. März 2019
Zuerst gepostet (Tatsächlich)
20. März 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
20. März 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
18. März 2019
Zuletzt verifiziert
1. März 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- MBRP for MMT
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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