NCT02588703

Brief Summary

The current study evaluates the efficacy of Cognitive Behavioral Therapy (CBT) in DUI programs for individuals with a first-time offense. Investigators will utilize a two-group randomized design where individuals enrolled in a DUI program with a first-time conviction will be randomized to Cognitive Behavioral Therapy (CBT; n=150) or Usual Care (UC; n=150). Participants will be assessed at baseline, immediately post-treatment, and 6-months post-treatment. Recidivism data will also be collected using administrative data two years post-treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
351

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2015

Typical duration for phase_2

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

First Submitted

Initial submission to the registry

August 17, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

April 10, 2020

Status Verified

April 1, 2020

Enrollment Period

2.8 years

First QC Date

August 17, 2015

Last Update Submit

April 8, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • heavy drinking (Survey)

    frequency of 5 drinks per day for men and 4 drinks per day for women

    6 months

Secondary Outcomes (1)

  • DUI Behaviors and Attitudes (Survey)

    6 months

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

9-session 2-hour group cognitive behavioral therapy

Behavioral: Cognitive Behavioral Therapy

Usual Care

ACTIVE COMPARATOR

9-session 2-hour group counseling

Behavioral: Usual Care

Interventions

Coping Skills Treatment

Also known as: CBT
Cognitive Behavioral Therapy
Usual CareBEHAVIORAL

Existing DUI program group counseling

Usual Care

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • meets criteria for at-risk drinking,
  • years+,
  • English speaking,
  • current client in 3-month DUI program

You may not qualify if:

  • under 21,
  • does not speak English,
  • does not meet criteria for at-risk drinking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chan Osilla K, Watkins KE, Kulesza M, Florez K, Lara-Greenberg M, Miles JN. Study design to evaluate cognitive behavioral therapy among a diverse sample of adults with a first-time DUI offense. Addict Sci Clin Pract. 2016 Mar 31;11(1):7. doi: 10.1186/s13722-016-0053-x.

MeSH Terms

Conditions

Alcoholism

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Karen C Osilla, PhD

    RAND

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Behavioral Scientist

Study Record Dates

First Submitted

August 17, 2015

First Posted

October 28, 2015

Study Start

October 1, 2015

Primary Completion

July 1, 2018

Study Completion

April 1, 2020

Last Updated

April 10, 2020

Record last verified: 2020-04