Trial Outcomes & Findings for CBT4CBT With Spanish Alcohol Users (NCT NCT03474588)
NCT ID: NCT03474588
Last Updated: 2024-11-26
Results Overview
The primary outcome measure will be percent days of abstinence (PDA) by week, presented are the raw means at each time point.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
By week for 8 weeks
Results posted on
2024-11-26
Participant Flow
Participant milestones
| Measure |
Standard Treatment (ST)
This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant
Standard Treatment (ST): ST includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks
|
Standard Treatment (ST) PLUS Web-based CBT4CBT
This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant PLUS
Participants will have access the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on.
Standard treatment (ST) PLUS web-based CBT4CBT: Participants will have access to the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
23
|
|
Overall Study
Follow up 1
|
27
|
21
|
|
Overall Study
Follow up 2
|
27
|
20
|
|
Overall Study
Follow up 3
|
25
|
18
|
|
Overall Study
COMPLETED
|
24
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Standard Treatment (ST)
This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant
Standard Treatment (ST): ST includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks
|
Standard Treatment (ST) PLUS Web-based CBT4CBT
This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant PLUS
Participants will have access the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on.
Standard treatment (ST) PLUS web-based CBT4CBT: Participants will have access to the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
CBT4CBT With Spanish Alcohol Users
Baseline characteristics by cohort
| Measure |
Standard Treatment (ST)
n=28 Participants
This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant
Standard Treatment (ST): ST includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks
|
Standard Treatment (ST) PLUS Web-based CBT4CBT
n=23 Participants
This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant PLUS
Participants will have access the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on.
Standard treatment (ST) PLUS web-based CBT4CBT: Participants will have access to the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.5 years
STANDARD_DEVIATION 13 • n=99 Participants
|
44.8 years
STANDARD_DEVIATION 11.9 • n=107 Participants
|
41.9 years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
23 participants
n=107 Participants
|
51 participants
n=206 Participants
|
|
Client Origin of birth
Client · Puerto Rico
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Client Origin of birth
Client · United States
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Client Origin of birth
Client · South American country
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Client Origin of birth
Client · Mexico
|
14 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Client Origin of birth
Client · Other Central American country
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Client Origin of birth
Client · Carribean Island
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Client Origin of birth
Mother · Puerto Rico
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Client Origin of birth
Mother · United States
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Client Origin of birth
Mother · South American country
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Client Origin of birth
Mother · Mexico
|
14 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Client Origin of birth
Mother · Other Central American country
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Client Origin of birth
Mother · Carribean Island
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Client Origin of birth
Father · Puerto Rico
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Client Origin of birth
Father · United States
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Client Origin of birth
Father · South American country
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Client Origin of birth
Father · Mexico
|
14 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Client Origin of birth
Father · Other Central American country
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Client Origin of birth
Father · Carribean Island
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Completed High School
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Never married/living alone
|
15 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Unemployed
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
On parole or probation
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Referred by criminal justice system
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
On Public Assistance
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Previous computer experience
|
21 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Lifetime anxiety disorder
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Lifetime major depression
|
16 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Lifetime PTSD by SCID
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Current PTSD by SCID
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Current anxiety disorder
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Current major depression
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Alcohol Use Disorder (AUD) Severity Rating
Mild
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Alcohol Use Disorder (AUD) Severity Rating
Moderate
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Alcohol Use Disorder (AUD) Severity Rating
Severe
|
21 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Diagnosed PTSD by PCL-5
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Alcohol Use Disorders Identification Test (Audit) Score 16 or higher
|
18 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Days paid for work in past 28
|
14.1 days
STANDARD_DEVIATION 11.6 • n=99 Participants
|
10.7 days
STANDARD_DEVIATION 10.1 • n=107 Participants
|
12.6 days
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Days of alcohol use in the past 28
|
9.1 days
STANDARD_DEVIATION 9.3 • n=99 Participants
|
7.7 days
STANDARD_DEVIATION 7.3 • n=107 Participants
|
8.5 days
STANDARD_DEVIATION 8.4 • n=206 Participants
|
|
Days of heavy alcohol use in the past 28
|
7 days
STANDARD_DEVIATION 8.7 • n=99 Participants
|
5.4 days
STANDARD_DEVIATION 6.4 • n=107 Participants
|
6.3 days
STANDARD_DEVIATION 7.7 • n=206 Participants
|
|
Drinks per drinking days in the past 28
|
8.6 drinks
STANDARD_DEVIATION 5.9 • n=99 Participants
|
10.9 drinks
STANDARD_DEVIATION 14.1 • n=107 Participants
|
9.6 drinks
STANDARD_DEVIATION 10.4 • n=206 Participants
|
|
Percent days of alcohol abstinence in the past 28
|
67.5 percentage of days
STANDARD_DEVIATION 33.2 • n=99 Participants
|
72.4 percentage of days
STANDARD_DEVIATION 26.2 • n=107 Participants
|
69.7 percentage of days
STANDARD_DEVIATION 30 • n=206 Participants
|
|
Percent days of heavy drinking in the past 28
|
25.2 percentage of days
STANDARD_DEVIATION 31.1 • n=99 Participants
|
19.3 percentage of days
STANDARD_DEVIATION 23 • n=107 Participants
|
22.5 percentage of days
STANDARD_DEVIATION 27.6 • n=206 Participants
|
|
Percent days of alcohol abstinence at week 0
|
73.5 percentage of days
STANDARD_DEVIATION 35.4 • n=99 Participants
|
77 percentage of days
STANDARD_DEVIATION 25.8 • n=107 Participants
|
75.1 percentage of days
STANDARD_DEVIATION 31.1 • n=206 Participants
|
|
Percent days of heavy drinking at week 0
|
20.4 percentage of days
STANDARD_DEVIATION 32.2 • n=99 Participants
|
14.9 percentage of days
STANDARD_DEVIATION 20.9 • n=107 Participants
|
17.9 percentage of days
STANDARD_DEVIATION 27.5 • n=206 Participants
|
|
Age first used alcohol
|
17.1 years
STANDARD_DEVIATION 4.9 • n=99 Participants
|
17.5 years
STANDARD_DEVIATION 6.8 • n=107 Participants
|
17.3 years
STANDARD_DEVIATION 5.8 • n=206 Participants
|
|
Years of alcohol use
|
21.1 years
STANDARD_DEVIATION 13.2 • n=99 Participants
|
25.8 years
STANDARD_DEVIATION 14.9 • n=107 Participants
|
23.2 years
STANDARD_DEVIATION 14 • n=206 Participants
|
|
Pre-treatment Alcohol Symptom Count
|
7.7 symptom count
STANDARD_DEVIATION 2.4 • n=99 Participants
|
7.6 symptom count
STANDARD_DEVIATION 2.6 • n=107 Participants
|
7.7 symptom count
STANDARD_DEVIATION 2.5 • n=206 Participants
|
|
Pre-treatment AUDIT Score
|
20.3 score on a scale
STANDARD_DEVIATION 9.2 • n=99 Participants
|
18.9 score on a scale
STANDARD_DEVIATION 7.7 • n=107 Participants
|
19.7 score on a scale
STANDARD_DEVIATION 8.5 • n=206 Participants
|
|
Years living in United States
|
19.5 years
STANDARD_DEVIATION 14 • n=99 Participants
|
19.2 years
STANDARD_DEVIATION 10 • n=107 Participants
|
19.3 years
STANDARD_DEVIATION 12.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: By week for 8 weeksPopulation: One participant was lost to follow up beginning week 4 in the Standard treatment (ST) PLUS web-based CBT4CBT.
The primary outcome measure will be percent days of abstinence (PDA) by week, presented are the raw means at each time point.
Outcome measures
| Measure |
Standard Treatment (ST) PLUS Web-based CBT4CBT
n=23 Participants
This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant PLUS
Participants will have access the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on.
Standard treatment (ST) PLUS web-based CBT4CBT: Participants will have access to the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on
|
Standard Treatment (ST)
n=28 Participants
This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant
Standard Treatment (ST): ST includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks
|
|---|---|---|
|
The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week
week 0 (baseline)
|
73.29 percentage of days abstinent per week
Standard Deviation 25.71
|
66.96 percentage of days abstinent per week
Standard Deviation 34.59
|
|
The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week
week 1
|
88.20 percentage of days abstinent per week
Standard Deviation 19.57
|
79.59 percentage of days abstinent per week
Standard Deviation 30.97
|
|
The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week
week 2
|
83.23 percentage of days abstinent per week
Standard Deviation 22.65
|
78.06 percentage of days abstinent per week
Standard Deviation 29.22
|
|
The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week
week 3
|
91.30 percentage of days abstinent per week
Standard Deviation 11.98
|
77.55 percentage of days abstinent per week
Standard Deviation 31.69
|
|
The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week
week 4
|
90.26 percentage of days abstinent per week
Standard Deviation 15.52
|
71.43 percentage of days abstinent per week
Standard Deviation 30.61
|
|
The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week
week 5
|
92.86 percentage of days abstinent per week
Standard Deviation 12.27
|
72.45 percentage of days abstinent per week
Standard Deviation 28.29
|
|
The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week
week 6
|
89.61 percentage of days abstinent per week
Standard Deviation 14.74
|
80.10 percentage of days abstinent per week
Standard Deviation 29.70
|
|
The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week
week 7
|
87.01 percentage of days abstinent per week
Standard Deviation 24.11
|
77.04 percentage of days abstinent per week
Standard Deviation 31.67
|
|
The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week
week 8
|
84.42 percentage of days abstinent per week
Standard Deviation 22.44
|
75.51 percentage of days abstinent per week
Standard Deviation 31.55
|
PRIMARY outcome
Timeframe: Months 3 through 8 (6 months total)Population: All participants assessed during the period.
Estimated means of sustained abstinence calculated as percent days per month from month 3 through 8 in post intervention follow up.
Outcome measures
| Measure |
Standard Treatment (ST) PLUS Web-based CBT4CBT
n=21 Participants
This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant PLUS
Participants will have access the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on.
Standard treatment (ST) PLUS web-based CBT4CBT: Participants will have access to the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on
|
Standard Treatment (ST)
n=27 Participants
This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant
Standard Treatment (ST): ST includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks
|
|---|---|---|
|
Monthly Abstinence From Alcohol
month 8
|
93.12 percentage of days abstinent in a month
Standard Deviation 10.55
|
74.59 percentage of days abstinent in a month
Standard Deviation 29.30
|
|
Monthly Abstinence From Alcohol
month 3
|
89.03 percentage of days abstinent in a month
Standard Deviation 10.55
|
77.46 percentage of days abstinent in a month
Standard Deviation 29.30
|
|
Monthly Abstinence From Alcohol
month 4
|
89.85 percentage of days abstinent in a month
Standard Deviation 10.55
|
76.88 percentage of days abstinent in a month
Standard Deviation 29.30
|
|
Monthly Abstinence From Alcohol
month 5
|
90.67 percentage of days abstinent in a month
Standard Deviation 10.55
|
76.31 percentage of days abstinent in a month
Standard Deviation 29.30
|
|
Monthly Abstinence From Alcohol
month 6
|
91.49 percentage of days abstinent in a month
Standard Deviation 10.55
|
75.74 percentage of days abstinent in a month
Standard Deviation 29.30
|
|
Monthly Abstinence From Alcohol
month 7
|
92.30 percentage of days abstinent in a month
Standard Deviation 10.55
|
75.17 percentage of days abstinent in a month
Standard Deviation 29.30
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Participants completing the full study.
Percent heavy drinking days during 8 weeks of trial
Outcome measures
| Measure |
Standard Treatment (ST) PLUS Web-based CBT4CBT
n=22 Participants
This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant PLUS
Participants will have access the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on.
Standard treatment (ST) PLUS web-based CBT4CBT: Participants will have access to the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on
|
Standard Treatment (ST)
n=28 Participants
This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant
Standard Treatment (ST): ST includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks
|
|---|---|---|
|
Secondary Outcomes Include Percent Heavy Drinking Days
|
6.4 percentage of heavy drinking days
Standard Deviation 10.3
|
15.2 percentage of heavy drinking days
Standard Deviation 22.7
|
SECONDARY outcome
Timeframe: last 4 weeks of treatment (4 weeks)Population: Participants completing the study.
Number of individuals with no heavy drinking days in the last 4 weeks of treatment
Outcome measures
| Measure |
Standard Treatment (ST) PLUS Web-based CBT4CBT
n=22 Participants
This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant PLUS
Participants will have access the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on.
Standard treatment (ST) PLUS web-based CBT4CBT: Participants will have access to the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on
|
Standard Treatment (ST)
n=28 Participants
This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant
Standard Treatment (ST): ST includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks
|
|---|---|---|
|
Number of Individuals With no Heavy Drinking Days in the Last 4 Weeks of Treatment
|
11 Participants
|
13 Participants
|
Adverse Events
Standard Treatment (ST)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Treatment (ST) PLUS Web-based CBT4CBT
Serious events: 4 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Standard Treatment (ST)
n=28 participants at risk
This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant
Standard Treatment (ST): ST includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks
|
Standard Treatment (ST) PLUS Web-based CBT4CBT
n=23 participants at risk
This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant PLUS
Participants will have access the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on.
Standard treatment (ST) PLUS web-based CBT4CBT: Participants will have access to the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on
|
|---|---|---|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
3.6%
1/28 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/28 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/28 • 8 weeks
|
8.7%
2/23 • Number of events 2 • 8 weeks
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/28 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Brian Kiluk, Ph.D.
Yale University Department of Psychiatry
Phone: 203-737-1544
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place