Alcohol Consumption
Conditions
Keywords
Alcohol dependence, Network Support, Cognitive-behavioral treatment, Relapse prevention, Consequences of drinking, Social network development
Brief summary
The Network Support project is part of an ongoing effort to improve treatment for alcohol dependent patients. The Network Support Project is designed to help patients change their social network from one that reinforces drinking behavior to one that reinforces sobriety. 160 patients will be assigned to one of two treatments. Each of the treatments will last 12 weeks. The first is a Network Support (NS) treatment designed to help patients develop new acquaintances and social networks. It is expected that alcohol dependent patients will benefit from increasing their contact with non-drinking people. This NS condition will be compared to a packaged CBT program for alcoholics (PCBT) that is designed to teach a number of skills to help people stop drinking, but does not address social networks per se. In order to better understand what is happening to the investigators patients, the investigators will be using daily computerized telephone calls to ask about people's experiences. This will be done both before and after treatment. Patients will also be asked to participate in follow-up interviews every 3 months for 2 years following the end of treatment.
Interventions
BEHAVIORALCoping Skills Training
Patients in both treatments will be taught skills to help them keep from drinking.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 18 yo * meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for alcohol dependence
Exclusion criteria
* acute medical or psychiatric problems that require inpatient treatment (e.g., acute psychosis, or suicide/homicide risk) * reading ability below the fifth grade level * lack of reliable transportation to the treatment site, or excessive commuting distance * inability to understand English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion Days Abstinent (PDA) | Every 3 months out to 2 years | PDA is based on data collected in each 90-day timeline follow-back assessment of daily drinking. PDA is calculated as the number of days out of 90 in which the patient reported 0 drinks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Network Change | assessed every 6 months out to 2 years, mean change over 2 years reported | Network Support for Abstinence. Minimum score=0; Maximum score =1. Higher scores indicate greater support for abstinence. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Network Support Network Support treatment is aimed at helping patients change their social support network so that it supports abstinence. In this treatment patients will be encouraged to attend AA meetings and engage in other activities that would involve non-drinkers. These activities would be determined by the patient, with help from the therapist. Patients would learn about methods of avoiding drinking, making new friends, and getting enjoyment from activities other than drinking. In addition patients will learn specific skills intended to help them make new acquaintances and change their circle of friends.
Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking. | 96 |
| Packaged Cognitive-Behavioral Treatment The purpose of Packaged Cognitive-Behavioral Treatment (PCBT) is to train patients in a variety of skills that they can use to keep themselves from drinking.
Coping Skills Training: Patients in both treatments will be taught skills to help them keep from drinking. | 97 |
| Total | 193 |
Baseline characteristics
| Characteristic | Network Support | Packaged Cognitive-Behavioral Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 96 Participants | 97 Participants | 193 Participants |
| Age, Continuous | 47.2 years STANDARD_DEVIATION 11.2 | 45.1 years STANDARD_DEVIATION 9.8 | 46.01 years STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants | 94 Participants | 187 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 92 Participants | 93 Participants | 185 Participants |
| Region of Enrollment United States | 96 participants | 97 participants | 193 participants |
| Sex: Female, Male Female | 37 Participants | 29 Participants | 66 Participants |
| Sex: Female, Male Male | 59 Participants | 68 Participants | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 96 | 2 / 97 |
| other Total, other adverse events | 5 / 96 | 5 / 97 |
| serious Total, serious adverse events | 30 / 96 | 35 / 97 |
Outcome results
Primary
Proportion Days Abstinent (PDA)
PDA is based on data collected in each 90-day timeline follow-back assessment of daily drinking. PDA is calculated as the number of days out of 90 in which the patient reported 0 drinks.
Time frame: Every 3 months out to 2 years
Population: Men and women aged 18-65 diagnosed with alcohol use disorder, moderate to severe.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Network Support | Proportion Days Abstinent (PDA) | .67 proportion of days abstinent | Standard Deviation 0.33 |
| Packaged Cognitive-Behavioral Treatment | Proportion Days Abstinent (PDA) | .73 proportion of days abstinent | Standard Deviation 0.33 |
p-value: <0.04Mixed Models Analysis
Secondary
Social Network Change
Network Support for Abstinence. Minimum score=0; Maximum score =1. Higher scores indicate greater support for abstinence.
Time frame: assessed every 6 months out to 2 years, mean change over 2 years reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Network Support | Social Network Change | .35 score on a scale | Standard Error 0.05 |
| Packaged Cognitive-Behavioral Treatment | Social Network Change | .30 score on a scale | Standard Error 0.05 |