Individualized Treatment Program for Alcohol Problems

NCT ID: NCT00298792

Last Updated: 2009-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Dependence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Individualized Assessment & treatment

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

Group Type EXPERIMENTAL

Cognitive Behavioral Treatment

Intervention Type BEHAVIORAL

Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety.

Cognitive-behavioral treatment

Intervention Type BEHAVIORAL

Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety

Packaged Cognitive-Behavioral Treatment

Manualized cognitive-behavioral treatment for alcohol dependent persons.

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Treatment

Intervention Type BEHAVIORAL

Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety.

Cognitive-behavioral treatment

Intervention Type BEHAVIORAL

Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive Behavioral Treatment

Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety.

Intervention Type BEHAVIORAL

Cognitive-behavioral treatment

Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Connecticut Health Center

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mark D. Litt, PhD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIH grant 1 R21 AA14202

Identifier Type: -

Identifier Source: secondary_id

NIAAALIT014202-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Brief Intervention for Heavy Drinkers
NCT00728767 COMPLETED PHASE3
Couples Therapy for Alcoholic Patients
NCT01659957 COMPLETED PHASE2