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Mindfulness for Alcohol Abusing Offenders (MIT)

Primary Purpose

Alcohol Abuse, Criminal Behavior

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness
Relapse Prevention
Sponsored by
The Mind Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • The Mind Research NetworkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

No Intervention

Arm Label

Mindfulness

Relapse Prevention

Waitlist Control

Treatment as Usual

Arm Description

Mindfulness

Outcomes

Primary Outcome Measures

Change from baseline alcohol craving
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.
Change from baseline daily alcohol consumption
Timeline Follow Back
Change from baseline temptation to drink alcohol
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.
Criminal Behavior
Crime Inventory

Secondary Outcome Measures

Full Information

First Posted
March 18, 2019
Last Updated
March 8, 2023
Sponsor
The Mind Research Network
Collaborators
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT03883646
Brief Title
Mindfulness for Alcohol Abusing Offenders
Acronym
MIT
Official Title
Mindfulness for Alcohol Abusing Offenders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Mind Research Network
Collaborators
University of Wisconsin, Madison

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Criminal Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
Mindfulness
Arm Title
Relapse Prevention
Arm Type
Experimental
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Title
Treatment as Usual
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
Mindfulness-based Relapse Prevention. Guided meditation/discussion (Group sessions).
Intervention Type
Behavioral
Intervention Name(s)
Relapse Prevention
Intervention Description
Relapse Prevention. Cognitive behavioral principles/strategies (Group sessions).
Primary Outcome Measure Information:
Title
Change from baseline alcohol craving
Description
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.
Time Frame
4 weeks, 8 weeks, and after release from incarceration (every 3 months)
Title
Change from baseline daily alcohol consumption
Description
Timeline Follow Back
Time Frame
Every 3 months after release from incarceration
Title
Change from baseline temptation to drink alcohol
Description
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.
Time Frame
4 weeks, 8 weeks, and after release from incarceration (every 3 months)
Title
Criminal Behavior
Description
Crime Inventory
Time Frame
An average of six months after release from incarceration

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenna Shold, PhD
Phone
505-400-5241
Email
jshold@mrn.org
Facility Information:
Facility Name
The Mind Research Network
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenna Shold, PhD
Phone
505-400-5241
Email
jshold@mrn.org

12. IPD Sharing Statement

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Mindfulness for Alcohol Abusing Offenders

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