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Individualized Treatment Program for Alcohol Problems (IATP)

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Treatment
Cognitive-behavioral treatment
Sponsored by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring Cognitive Behavioral Treatment, Alcohol Dependence, Functional Analysis, Experience Sampling, Interactive Voice Response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female outpatients 18 years of age or older. Participants will have a current DSM-IV diagnosis of alcohol dependence. Participants will have signed a witnessed informed consent. Exclusion Criteria: Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, dementia, or a psychological disorder requiring medication. Participants who have had more than seven days of inpatient treatment for substance use disorders in the 30 days previous to randomization.

Sites / Locations

  • University of Connecticut Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individualized Assessment & treatment

Packaged Cognitive-Behavioral Treatment

Arm Description

Individualized treatment for alcohol dependent persons, based on momentary assessment of high-risk situations and recorded coping abilities.

Manualized cognitive-behavioral treatment for alcohol dependent persons.

Outcomes

Primary Outcome Measures

Alcohol consumption

Secondary Outcome Measures

Alcohol-related life problems

Full Information

First Posted
March 1, 2006
Last Updated
April 14, 2009
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00298792
Brief Title
Individualized Treatment Program for Alcohol Problems
Acronym
IATP
Official Title
Individualized Treatment Program for Alcohol Problems
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if a treatment for alcohol dependence that is specifically tailored to patients' patterns of drinking and coping strategies can result in better outcomes than more standardized treatments.
Detailed Description
Despite the popularity of Cognitive-Behavioral Treatment (CBT) in substance use disorders, recent findings have indicated that CBT may be no more effective than other, less theoretically driven, treatments, and that CBT treatments often fail to result in coping skills acquisition. In order to explore the possibility that current manual-driven modes of CBT delivery may not be adequate to successfully teach coping skills, we are proposing a pilot project for the development of an individualized assessment and cognitive-behavioral treatment program (IATP) for alcohol-dependent persons, in which experience sampling conducted via random calls to cell-phones is used to provide data to create individualized treatment plans. Data collected during experience sampling will include momentary assessments of patients' cognitions, affects, and coping behaviors with respect to drinking. Participants will be 112 men and women meeting criteria for alcohol dependence, who will be randomly assigned to either a standard packaged manual-driven cognitive-behavioral treatment program (PCBT) like that used in Project MATCH, or to IATP. Patients in both treatments will be asked to engage in experience sampling for two weeks prior to treatment, and for another two weeks after treatment has ended, in order to compare in-vivo measures of coping skills utilization, pre- and posttreatment, between the two groups. Therapy will be conducted over 12 sessions in both treatments. In IATP, the information gathered from experience sampling will form the basis of a functional analysis of patients' drinking and drinking urges during the monitoring period. Cognitive appraisals, moods and coping responses will be evaluated as antecedents and consequences of drinking behavior. Therapists will use the information to address specific cognitions, affects, and behaviors that are adaptive and maladaptive, and will work with the patient to substitute adaptive coping tactics instead. In PCBT the experience sampling data will not be specifically used in therapy, but will still provide in-vivo measures of drinking and coping skills. It is hypothesized that IATP will yield significantly better coping skills acquisition than will PCBT, and that change in coping skills will predict better posttreatment outcomes for IATP. These results would have implications for our delivery of treatment, and for the validity of coping skills training for alcohol addiction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
Keywords
Cognitive Behavioral Treatment, Alcohol Dependence, Functional Analysis, Experience Sampling, Interactive Voice Response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualized Assessment & treatment
Arm Type
Experimental
Arm Description
Individualized treatment for alcohol dependent persons, based on momentary assessment of high-risk situations and recorded coping abilities.
Arm Title
Packaged Cognitive-Behavioral Treatment
Arm Type
Active Comparator
Arm Description
Manualized cognitive-behavioral treatment for alcohol dependent persons.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Treatment
Intervention Description
Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral treatment
Intervention Description
Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety
Primary Outcome Measure Information:
Title
Alcohol consumption
Time Frame
Pre - Post
Secondary Outcome Measure Information:
Title
Alcohol-related life problems
Time Frame
Pre - Post

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female outpatients 18 years of age or older. Participants will have a current DSM-IV diagnosis of alcohol dependence. Participants will have signed a witnessed informed consent. Exclusion Criteria: Participants who meet current DSM-IV criteria for bipolar disorder, schizophrenia, dementia, or a psychological disorder requiring medication. Participants who have had more than seven days of inpatient treatment for substance use disorders in the 30 days previous to randomization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D. Litt, PhD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States

12. IPD Sharing Statement

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Individualized Treatment Program for Alcohol Problems

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