Individualized Treatment Program for Alcohol Problems (IATP)

This study has been completed.
Sponsor:
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:
NCT00298792
First received: March 1, 2006
Last updated: April 14, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Alcohol Dependence
Behavioral: Cognitive Behavioral Treatment
Behavioral: Cognitive-behavioral treatment
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Individualized Treatment Program for Alcohol Problems

Resource links provided by NLM:


Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:
  • Alcohol consumption [ Time Frame: Pre - Post ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alcohol-related life problems [ Time Frame: Pre - Post ] [ Designated as safety issue: No ]

Enrollment: 110
Study Start Date: January 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Individualized Assessment & treatment
Individualized treatment for alcohol dependent persons, based on momentary assessment of high-risk situations and recorded coping abilities.
Behavioral: Cognitive Behavioral Treatment
Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety.
Behavioral: Cognitive-behavioral treatment
Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety
Active Comparator: Packaged Cognitive-Behavioral Treatment
Manualized cognitive-behavioral treatment for alcohol dependent persons.
Behavioral: Cognitive Behavioral Treatment
Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety.
Behavioral: Cognitive-behavioral treatment
Psychosocial treatment emphasizing teaching of coping skills to maintain sobriety

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298792

Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
Investigators
Principal Investigator: Mark D. Litt, PhD University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: Mark D. Litt, Ph.D., Principal Investigator, University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00298792     History of Changes
Other Study ID Numbers: NIAAALIT014202-02, NIH grant 1 R21 AA14202
Study First Received: March 1, 2006
Last Updated: April 14, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):
Cognitive Behavioral Treatment
Alcohol Dependence
Functional Analysis
Experience Sampling
Interactive Voice Response

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014