- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03883646
Mindfulness for alkoholmisbrukere (MIT)
Over half of state and federal prisoners meet clinical criteria for alcohol abuse or dependence, and after release from prison, over three-quarters of offenders are re-arrested within five years. Thus, there is a critical need for more effective interventions that could help disrupt this insidious cycle of alcohol abuse, criminal behavior, and incarceration. This project will support the development and evaluation of a mindfulness intervention for female prison inmates that will target key neuropsychological vulnerabilities that are associated with relapse and recidivism.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The pernicious link between substance abuse and criminal behavior imposes major costs to society, totaling billions of dollars in the U.S. annually. There is a critical need for more effective interventions to counteract the high rates of relapse and recidivism in alcohol and substance abusing criminal offenders. Periods of offender incarceration provide a unique opportunity to develop and deploy such interventions. Progress in intervention development could be achieved by targeting specific cognitive and affective vulnerabilities that are common among substance abusing criminal offenders. Preliminary studies suggest that meditative or mindfulness interventions may confer significant psychological and behavioral benefits to inmates. However, the mechanisms and extent of intervention efficacy are unclear, as these previous studies have been beset by a number of methodological limitations. Moreover, to date no study has examined the neurobiological mechanisms that relate to treatment success in this population. NIAAA has recently made a program call to address these issues (PA-15-299). Here we answer this program call and propose to undertake a rigorous and comprehensive longitudinal study of mindfulness treatment of alcohol and substance use disorders among female inmates. This project will randomly assign over 400 female inmates to a mindfulness or relapse prevention training course, and both will be compared against a no treatment control. The mindfulness intervention will be tailored to address two key neuropsychological deficits in alcohol abusing criminal offenders: impulsivity and craving. We will test hypotheses about the neural changes over time with treatment to elucidate mechanisms of change. We will obtain estimates of "real-world" efficacy of the intervention by collecting outcome measures in prison (conduct reports) and following release (alcohol use relapse and antisocial behavior). This project takes advantage of a unique, longstanding partnership between the research team and the states of New Mexico and Wisconsin Correction Departments that allows collection of comprehensive assessment data from inmates during incarceration, including brain imaging data with a mobile MRI scanner, as well as access to post-release outcomes and relapse data. Completion of these aims is a critical step for implementing and evaluating a promising mindfulness intervention for this high-risk population. The proposed research will also begin to elucidate the psychological and neurobiological mechanisms of the treatment. These results will thus significantly advance a program of research seeking to translate the growing knowledge of neuropsychological deficits into more targeted and effective treatments for alcohol and substance abuse problems in criminal offenders.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87106
- The Mind Research Network
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 18-65 years of age
- Alcohol Use Disorder
- Female (biological sex at birth)
- Time to release from incarceration > 3 months
- 5th grade or higher reading level
- Able to speak and understand English
Exclusion Criteria:
- Uncorrectable auditory or visual deficits
- Intelligence Quotient score below 70
- History of dementia or other cognitive disability
- Current psychotic disorder (chronic schizophrenia or schizoaffective disorder and/or active psychotic symptoms)
- Major medical illness or Central Nervous System disease
- MRI incompatibility (e.g., metal in body)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Behandling som vanlig
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Ingen inngripen: Ventelistekontroll
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Eksperimentell: Tilbakefallsforebygging
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Relapse Prevention. Cognitive behavioral principles/strategies (Group sessions). |
|
Eksperimentell: Mindfulness
Mindfulness |
Mindfulness-based Relapse Prevention. Guided meditation/discussion (Group sessions). |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline Alcohol Craving
Tidsramme: Baseline (before treatment started) and Post-treatment (immediately after 8-week treatment ended). Waitlist and Treatment as Usual participants were given assessments at the same timeframe as those who participated in treatment.
|
Penn Alcohol Craving Scale. 5-item, self-report measure assessing frequency, intensity, and duration of craving, and overall rating of craving for the previous week. Total score range 0-30. Higher scores indicate higher craving. |
Baseline (before treatment started) and Post-treatment (immediately after 8-week treatment ended). Waitlist and Treatment as Usual participants were given assessments at the same timeframe as those who participated in treatment.
|
|
Change From Baseline Daily Depression
Tidsramme: Baseline (before treatment started) and Post-treatment (immediately after 8-week treatment ended). Waitlist and Treatment as Usual participants were given assessments at the same timeframe as those who participated in treatment.
|
Beck Depression Inventory-II (BDI-II). Assesses participants' self-reported depression in the past two weeks. Data for total scores is provided (range: 0-63). Higher scores indicate increased severity of depressive symptoms. |
Baseline (before treatment started) and Post-treatment (immediately after 8-week treatment ended). Waitlist and Treatment as Usual participants were given assessments at the same timeframe as those who participated in treatment.
|
|
Change From Baseline Perception of Quality of Life
Tidsramme: Baseline (before treatment started) and Post-treatment (immediately after 8-week treatment ended). Waitlist and Treatment as Usual participants were given assessments at the same timeframe as those who participated in treatment.
|
World Health Organization Quality of Life - Brief (WHOQOL-BREF). 26-item, self-report measure assessing how individuals perceive their quality of life across domains. Data for psychological health is reported (range: 6-30). Higher scores indicate increased psychological health. |
Baseline (before treatment started) and Post-treatment (immediately after 8-week treatment ended). Waitlist and Treatment as Usual participants were given assessments at the same timeframe as those who participated in treatment.
|
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Proportion of Participants Who Were Not Arrested Following Release From Incarceration
Tidsramme: 30 months following release from incarceration; misdemeanor and felony arrests were cataloged across the treatment arms.
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Arrests on misdemeanor and felony charges were the categories used to track criminal behavior in the study participants. To evaluate the effect of the treatment on criminal behavior, we used official state databases to track criminal activity for participants who were released from incarceration post-treatment. |
30 months following release from incarceration; misdemeanor and felony arrests were cataloged across the treatment arms.
|
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Participant Reflections on Their Treatment Program
Tidsramme: Post-treatment (immediately after 8-week treatment ended)
|
During the last session of treatment, participants were given a "Reflections on the Course" handout, where they provided feedback on the treatment they received. Participants were asked to provide a rating to the following question:
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Post-treatment (immediately after 8-week treatment ended)
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Investigate Behavioral and Neural Changes Related to Alcohol Craving During Treatment
Tidsramme: Baseline (before treatment) and Post-treatment (immediately after 8-week treatment ended). Waitlist and Treatment as Usual participants were given scans at the same timeframe as those who participated in treatment.
|
Salience Alcohol Task (SAT): A drug-cue reactivity functional Magnetic Resonance Imaging (fMRI) task, whereby participants viewed different stimuli (i.e., alcohol cues, negatively valanced stimuli, or neutrally valanced stimuli). After seeing each image, participants were asked to respond to which type of image they saw (i.e., alcohol cues, neutral cues, and negatively valanced cues). Participants completed this task pre-/post-treatment. Independent component analysis was used to extract brain regions related to alcohol cue reactivity, in order to assess functional connectivity changes related to treatment between these regions. Values below represent positive change in z-scores (post - pre-treatment) related to increased functional network connectivity between the anterior cingulate cortex and anterior insula, regions commonly involved in salience detection. A z-score of 0 represents the population mean. All four groups showed increased functional connectivity with z-scores above 0. |
Baseline (before treatment) and Post-treatment (immediately after 8-week treatment ended). Waitlist and Treatment as Usual participants were given scans at the same timeframe as those who participated in treatment.
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Psykiske lidelser
- Stoffrelaterte lidelser
- Kjemisk-induserte lidelser
- Alkoholrelaterte lidelser
- Oppførsel
- Alkoholisme
- Kriminell atferd
- Terapeutikk
- Folkehelse
- Miljø og folkehelse
- Helsetjenester
- Helsetjenester arbeidsstyrke og tjenester
- Forebyggende helsetjenester
- Atferdsterapi
- Psykoterapi
- Atferdsdisipliner og aktiviteter
- Kognitiv atferdsterapi
- Folkehelsepraksis
- Mindfulness
- Sekundær forebygging
Andre studie-ID-numre
- 18114
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