Trial Outcomes & Findings for Study of the Effects of Motivational Enhancement Therapy on Alcohol Use in Chronic Hepatitis C Patients (NCT NCT00596960)
NCT ID: NCT00596960
Last Updated: 2014-11-28
Results Overview
A standard drink was considered 14 oz. of alcohol or12 oz of regular beer, 5 oz of regular wine, or 1.5 oz of distilled spirits. The number of drinks per week was measured for 30 a day time frame at baseline, 3 months and 6-months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
139 participants
Primary outcome timeframe
6-months
Results posted on
2014-11-28
Participant Flow
Participant milestones
| Measure |
Arm 1
Motivational enhancement therapy
Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH.
|
Arm 2
health education intervention
Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
69
|
|
Overall Study
COMPLETED
|
59
|
60
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
Reasons for withdrawal
| Measure |
Arm 1
Motivational enhancement therapy
Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH.
|
Arm 2
health education intervention
Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training.
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
6
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Incarcerated
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
No alcohol use data
|
0
|
1
|
Baseline Characteristics
Study of the Effects of Motivational Enhancement Therapy on Alcohol Use in Chronic Hepatitis C Patients
Baseline characteristics by cohort
| Measure |
Arm 1
n=70 Participants
Motivational enhancement therapy
Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH.
|
Arm 2
n=69 Participants
health education intervention
Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.8 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
55.2 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
48 participants
n=5 Participants
|
46 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=5 Participants
|
69 participants
n=7 Participants
|
139 participants
n=5 Participants
|
|
Percentage of days abstinent
|
34.98 percentage of days abstinent
STANDARD_DEVIATION 26.7 • n=5 Participants
|
34.63 percentage of days abstinent
STANDARD_DEVIATION 27.0 • n=7 Participants
|
34.81 percentage of days abstinent
STANDARD_DEVIATION 26.8 • n=5 Participants
|
|
Mean standard drinks per week
|
35.45 Standard drinks of alcohol
STANDARD_DEVIATION 25.42 • n=5 Participants
|
38.86 Standard drinks of alcohol
STANDARD_DEVIATION 46.19 • n=7 Participants
|
37.13 Standard drinks of alcohol
STANDARD_DEVIATION 37.03 • n=5 Participants
|
|
Beck Depression Inventory-II
|
17.40 units on a scale
STANDARD_DEVIATION 11.58 • n=5 Participants
|
17.31 units on a scale
STANDARD_DEVIATION 10.79 • n=7 Participants
|
17.36 units on a scale
STANDARD_DEVIATION 11.16 • n=5 Participants
|
|
Brief Symptom Inventory
|
51.23 units on a scale
STANDARD_DEVIATION 41.23 • n=5 Participants
|
56.91 units on a scale
STANDARD_DEVIATION 44.18 • n=7 Participants
|
54.05 units on a scale
STANDARD_DEVIATION 42.66 • n=5 Participants
|
|
Posttraumatic stress disorder checklist - Civilian (PCL-C)
|
38.01 units on a scale
STANDARD_DEVIATION 15.21 • n=5 Participants
|
40.61 units on a scale
STANDARD_DEVIATION 16.04 • n=7 Participants
|
39.28 units on a scale
STANDARD_DEVIATION 15.62 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6-monthsA standard drink was considered 14 oz. of alcohol or12 oz of regular beer, 5 oz of regular wine, or 1.5 oz of distilled spirits. The number of drinks per week was measured for 30 a day time frame at baseline, 3 months and 6-months.
Outcome measures
| Measure |
Arm 1
n=70 Participants
Motivational enhancement therapy
Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH.
|
Arm 2
n=68 Participants
health education intervention
Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training.
|
|---|---|---|
|
The Number of Alcohol Drinks Per Week (as Measured by the Time Line Follow Back Procedure) at the 6 Month Follow-up.
|
14.88 Standard Alcohol drinks
Standard Deviation 27.94
|
21.41 Standard Alcohol drinks
Standard Deviation 29.39
|
PRIMARY outcome
Timeframe: 6-monthsAlcohol use was measured for 30 days at baseline, 3-months and 6-months using the time-line follow back method. Percent days abstinent was measured by determining: days abstinent/30days X 100=%days abstinent.
Outcome measures
| Measure |
Arm 1
n=70 Participants
Motivational enhancement therapy
Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH.
|
Arm 2
n=68 Participants
health education intervention
Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training.
|
|---|---|---|
|
Percent Days Abstinent From Alcohol at 6 Months
|
73.15 percentage of days abstinent
Standard Deviation 32.18
|
59.49 percentage of days abstinent
Standard Deviation 35.30
|
SECONDARY outcome
Timeframe: 6-monthsThis was measured as heavy drinking days per 30 day time frame. A standard drink was considered 14 oz. of alcohol or12 oz of regular beer, 5 oz of regular wine, or 1.5 oz of distilled spirits. A heavy drinking day was considered to be 4 or greater drinks during a day.
Outcome measures
| Measure |
Arm 1
n=70 Participants
Motivational enhancement therapy
Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH.
|
Arm 2
n=68 Participants
health education intervention
Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training.
|
|---|---|---|
|
Heavy Drinking Days (Greater or Equal to 4 Drinks)
|
5.10 heavy drinking days
Standard Deviation 8.1
|
7.38 heavy drinking days
Standard Deviation 9.53
|
Adverse Events
Arm 1
Serious events: 7 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
Serious events: 14 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=70 participants at risk
Motivational enhancement therapy
Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH.
|
Arm 2
n=69 participants at risk
health education intervention
Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training.
|
|---|---|---|
|
Hepatobiliary disorders
Liver failure
|
1.4%
1/70 • Number of events 1
|
4.3%
3/69 • Number of events 3
|
|
Psychiatric disorders
psychiatric symptoms
|
1.4%
1/70 • Number of events 1
|
2.9%
2/69 • Number of events 2
|
|
Psychiatric disorders
Alcohol intoxication
|
2.9%
2/70 • Number of events 2
|
5.8%
4/69 • Number of events 4
|
|
Cardiac disorders
myocardial infarction
|
1.4%
1/70 • Number of events 1
|
0.00%
0/69
|
|
Hepatobiliary disorders
GI distress
|
1.4%
1/70 • Number of events 1
|
4.3%
3/69 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
fracture
|
1.4%
1/70 • Number of events 1
|
1.4%
1/69 • Number of events 1
|
|
Cardiac disorders
chest pain
|
0.00%
0/70
|
1.4%
1/69 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place