NCT03883646

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
392

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

6.8 years

First QC Date

March 18, 2019

Last Update Submit

September 22, 2025

Conditions

Alcohol AbuseCriminal Behavior

Outcome Measures

Primary Outcomes (4)

  • 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.

    4 weeks, 8 weeks, and after release from incarceration (every 3 months)

  • Change from baseline daily alcohol consumption

    Timeline Follow Back

    Every 3 months after release from incarceration

  • 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.

    4 weeks, 8 weeks, and after release from incarceration (every 3 months)

  • Criminal Behavior

    Crime Inventory

    An average of six months after release from incarceration

Study Arms (4)

Mindfulness

EXPERIMENTAL

Mindfulness

Behavioral: Mindfulness

Relapse Prevention

EXPERIMENTAL
Behavioral: Relapse Prevention

Waitlist Control

NO INTERVENTION

Treatment as Usual

NO INTERVENTION

Interventions

MindfulnessBEHAVIORAL

Mindfulness-based Relapse Prevention. Guided meditation/discussion (Group sessions).

Mindfulness
Relapse PreventionBEHAVIORAL

Relapse Prevention. Cognitive behavioral principles/strategies (Group sessions).

Relapse Prevention

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Alcohol Use Disorder
  • Female (biological sex at birth)
  • Time to release from incarceration \> 3 months
  • th grade or higher reading level
  • Able to speak and understand English

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Mind Research Network

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

AlcoholismCriminal Behavior

Interventions

MindfulnessSecondary Prevention

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesTherapeuticsPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPublic Health PracticePublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology, Neuroscience and Law, Executive Science Officer

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 21, 2019

Study Start

July 1, 2018

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

September 26, 2025

Record last verified: 2025-09

Locations

US(1)