Alcoholism
Conditions
Keywords
Psychotherapy motivational intervention
Brief summary
The purpose of this study is to determine whether a health focused motivational intervention will reduce alcohol use for dependent veterans who are receiving outpatient alcohol and drug treatment.
Detailed description
The early months of addiction treatment are a high risk time for relapse. The purpose of this study is to examine whether a health-related intervention delivered in an individual session with a therapist once per month in the initial 4 months of addiction treatment will reduce alcohol use among veterans already enrolled in weekly outpatient treatment group at the VA San Diego Healthcare System. In order to answer this question, study participants will be randomly assigned to one of three study conditions: 1) The Health Motivational condition that receives individual personalized health feedback and motivational activities, 2) the Health Education condition that receives individual education about health problems associated with the heavy alcohol use, and 3) the treatment as usual group that will receive no additional treatment. All participants will be assessed on a monthly basis for 4 months to evaluate alcohol use, drug use, and health status.
Interventions
BEHAVIORALHealth Motivational Feedback
Personalized feedback on health status
BEHAVIORALHealth Education
Generalized health education related to alcohol use
BEHAVIORALControl - treatment as usual
Control group with no additional intervention
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- Veterans receiving outpatient treatment at the VA San Diego Healthcare System Alcohol and Drug Treatment Program for a diagnosis of Alcohol Dependence
Exclusion criteria
* Diagnosis of Bipolar Disorder or Psychotic Disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Days Abstinent From Alcohol | 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Days Abstinent From All Substances | 4 months | Percentage of days abstinent from both alcohol and drugs |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Health Motivational Feedback Personalized health-related feedback
Health Motivational Feedback: Personalized feedback on health status | 35 |
| Health Education Non-personalized didactic health-related education
Health Education: Generalized health education related to alcohol use | 30 |
| Control - Treatment as Usual No added treatment control
Control - treatment as usual: Control group with no additional intervention | 34 |
| Total | 99 |
Baseline characteristics
| Characteristic | Health Motivational Feedback | Health Education | Control - Treatment as Usual | Total |
|---|---|---|---|---|
| Age, Continuous | 48.1 years STANDARD_DEVIATION 11 | 49.4 years STANDARD_DEVIATION 8.2 | 49.1 years STANDARD_DEVIATION 11.7 | 48.8 years STANDARD_DEVIATION 10.4 |
| Percentage Days Abstinent alcohol | 49.1 percentage STANDARD_DEVIATION 31 | 60.1 percentage STANDARD_DEVIATION 31.9 | 48.2 percentage STANDARD_DEVIATION 28.8 | 52.1 percentage STANDARD_DEVIATION 30.7 |
| Percentage Days Abstinent all substances | 48.6 percentage STANDARD_DEVIATION 31.5 | 59.6 percentage STANDARD_DEVIATION 32 | 47.4 percentage STANDARD_DEVIATION 29.2 | 51.5 percentage STANDARD_DEVIATION 31 |
| Region of Enrollment United States | 35 participants | 30 participants | 34 participants | 99 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 31 Participants | 27 Participants | 32 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 35 | 0 / 30 | 0 / 34 |
| serious Total, serious adverse events | 1 / 35 | 0 / 30 | 0 / 34 |
Outcome results
Primary
Percentage of Days Abstinent From Alcohol
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Motivational Feedback | Percentage of Days Abstinent From Alcohol | 91.4 percentage of days abstinent alcohol | Standard Deviation 14.2 |
| Health Education | Percentage of Days Abstinent From Alcohol | 87.3 percentage of days abstinent alcohol | Standard Deviation 23.6 |
| Control - Treatment as Usual | Percentage of Days Abstinent From Alcohol | 83.0 percentage of days abstinent alcohol | Standard Deviation 26.8 |
p-value: 0.32ANOVA
Secondary
Percentage of Days Abstinent From All Substances
Percentage of days abstinent from both alcohol and drugs
Time frame: 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Motivational Feedback | Percentage of Days Abstinent From All Substances | 91.2 percentage of days abstinent | Standard Deviation 14.2 |
| Health Education | Percentage of Days Abstinent From All Substances | 84.1 percentage of days abstinent | Standard Deviation 27.8 |
| Control - Treatment as Usual | Percentage of Days Abstinent From All Substances | 82.1 percentage of days abstinent | Standard Deviation 26.7 |