Clinical trial NCT00298792: Individualized Treatment Program for Alcohol Problems
Official title: Individualized Treatment Program for Alcohol Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alcohol Dependence
Keywords: Cognitive Behavioral Treatment
Alcohol Dependence
Functional Analysis
Experience Sampling
Interactive Voice Response
Lead sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Sponsor class: NIH
First posted: 2006-03-03
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Alcohol consumption
timeFrame: Pre - Post
Secondary outcomes:
measure: Alcohol-related life problems
timeFrame: Pre - Post
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Mark D. Litt, PhD
role: PRINCIPAL_INVESTIGATOR
References: