- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03883646
Mindfulness for Alcohol Abusing Offenders (MIT)
March 21, 2024 updated by: Kent Kiehl, The Mind Research Network
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
480
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jenna Shold, PhD
- Phone Number: 505-400-5241
- Email: jshold@mrn.org
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87106
- Recruiting
- The Mind Research Network
-
Contact:
- Jenna Shold, PhD
- Phone Number: 505-400-5241
- Email: jshold@mrn.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Treatment as Usual
|
|
No Intervention: Waitlist Control
|
|
Experimental: Mindfulness
|
Mindfulness-based Relapse Prevention.
Guided meditation/discussion (Group sessions).
|
Experimental: Relapse Prevention
|
Relapse Prevention.
Cognitive behavioral principles/strategies (Group sessions).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline alcohol craving
Time Frame: 4 weeks, 8 weeks, and after release from incarceration (every 3 months)
|
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.
|
4 weeks, 8 weeks, and after release from incarceration (every 3 months)
|
Change from baseline daily alcohol consumption
Time Frame: Every 3 months after release from incarceration
|
Timeline Follow Back
|
Every 3 months after release from incarceration
|
Change from baseline temptation to drink alcohol
Time Frame: 4 weeks, 8 weeks, and after release from incarceration (every 3 months)
|
Abstinence Self-Efficacy Scale.
40-item, self-report measure assessing how tempted the participant found themselves to drink under various circumstances.
Total score range 0-160.
Higher scores indicate higher temptation to drink.
|
4 weeks, 8 weeks, and after release from incarceration (every 3 months)
|
Criminal Behavior
Time Frame: An average of six months after release from incarceration
|
Crime Inventory
|
An average of six months after release from incarceration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2018
Primary Completion (Estimated)
April 30, 2024
Study Completion (Estimated)
April 30, 2024
Study Registration Dates
First Submitted
March 18, 2019
First Submitted That Met QC Criteria
March 19, 2019
First Posted (Actual)
March 21, 2019
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18114
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Abuse
-
The Morton Center, Inc.National Institute on Alcohol Abuse and Alcoholism (NIAAA)UnknownAlcohol Dependence | Cannabis Dependence | Alcohol Abuse | Cannabis Abuse | Other Substance AbuseUnited States
-
Michael E. DeBakey VA Medical CenterUnknownAlcohol Dependence | Alcohol Abuse | Substance Abuse ProblemUnited States
-
Polaris Health DirectionsUniversity of Massachusetts, WorcesterCompletedAlcohol Abuse, Alcohol DependenceUnited States
-
Australian National UniversityUniversity of Peradeniya; Department of Foregin Affairs and Trade, AustraliaCompletedIntimate Partner Violence | Domestic Abuse | Drug and Alcohol AbuseAustralia
-
Kent State UniversityCompletedAlcohol Use Disorder | Alcohol Abuse | Alcohol Abuse, EpisodicUnited States
-
National Institute on Drug Abuse (NIDA)CompletedDrug/Substance Abuse/Addiction | Alcohol Abuse/AddictionUnited States
-
Queen Mary University of LondonBarts & The London NHS Trust; University of HertfordshireRecruitingAlcohol Use Disorder | Alcohol Abuse or DependenceUnited Kingdom
-
National Institute on Drug Abuse (NIDA)CompletedSubstance Abuse | Drug Abuse | Alcohol AbuseUnited States
-
Baylor College of MedicineCompletedAlcohol Dependence | Substance Abuse | Alcohol AbuseUnited States
-
Fundació Sant Joan de DéuInstituto de Salud Carlos III; European Union; University of Barcelona; Red Salud...UnknownAlcohol Abuse in PregnancySpain
Clinical Trials on Mindfulness
-
University of Illinois at Urbana-ChampaignNorthwestern University Feinberg School of Medicine; Southern Illinois University and other collaboratorsNot yet recruitingPain, Postoperative | Depression, Unipolar
-
University of HoustonCompletedDepression | Stress | Anxiety | Well-beingUnited States
-
University of UlsterRecruitingCervical Cancer | Gynecologic Cancer | Vulvar Cancer | Vaginal Cancer | Uterus Cancer | Ovary CancerUnited Kingdom
-
University of HawaiiVA Palo Alto Health Care SystemCompletedCancer, Other Than Non-melanoma Skin CancerUnited States
-
Monash University MalaysiaCompleted
-
Oregon Health and Science UniversityPortland VA Medical CenterCompleted
-
Lund UniversityCompleted
-
Sam Houston State UniversityTerminated