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Study of the Effects of Motivational Enhancement Therapy on Alcohol Use in Chronic Hepatitis C Patients

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ClinicalTrials.gov Identifier: NCT00596960
Recruitment Status : Completed
First Posted : January 17, 2008
Results First Posted : November 28, 2014
Last Update Posted : November 28, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Alcohol Dependence
Chronic Hepatitis C
Interventions Behavioral: Motivational Enhancement Therapy (MET)
Behavioral: Health education
Enrollment 139
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 Arm 2
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Motivational enhancement therapy

Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH.

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.

Period Title: Overall Study
Started 70 69 [1]
Completed 59 60
Not Completed 11 9
Reason Not Completed
Death             1             2
Lost to Follow-up             6             5
Withdrawal by Subject             1             0
Incarcerated             2             0
Physician Decision             1             0
Protocol Violation             0             1
No alcohol use data             0             1
[1]
One subject did not have any alcohol use data and thus was excluded from the statistical analysis
Arm/Group Title Arm 1 Arm 2 Total
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Motivational enhancement therapy

Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH.

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 of all reporting groups
Overall Number of Baseline Participants 70 69 139
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 69 participants 139 participants
55.8  (6.8) 55.2  (6.3) 55.5  (6.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 69 participants 139 participants
Female
2
   2.9%
4
   5.8%
6
   4.3%
Male
68
  97.1%
65
  94.2%
133
  95.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 70 participants 69 participants 139 participants
Caucasian 48 46 94
African American 20 21 41
Native American 0 2 2
Other 2 0 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 70 participants 69 participants 139 participants
70 69 139
Percentage of days abstinent   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of days abstinent
Number Analyzed 70 participants 69 participants 139 participants
34.98  (26.7) 34.63  (27.0) 34.81  (26.8)
[1]
Measure Description: Percentage of days abstinent from alcohol as measured by the time line follow back method in the past 30 days.
Mean standard drinks per week  
Mean (Standard Deviation)
Unit of measure:  Standard drinks of alcohol
Number Analyzed 70 participants 69 participants 139 participants
35.45  (25.42) 38.86  (46.19) 37.13  (37.03)
Beck Depression Inventory-II   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 70 participants 69 participants 139 participants
17.40  (11.58) 17.31  (10.79) 17.36  (11.16)
[1]
Measure Description: The Beck Depression Inventory-II is a continuous measure of depressive symptoms. Maximum score is 63 with a range of 0 to 63. Higher scores indicate more severe depressive symptoms.
Brief Symptom Inventory   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 70 participants 69 participants 139 participants
51.23  (41.23) 56.91  (44.18) 54.05  (42.66)
[1]
Measure Description: The Brief Symptom Inventory (BSI) is a 53 item self-report instrument that reflects 9 symptom dimensions: Somatization (SOM), Obsessive-compulsive (0-C), Interpersonal sensitivity (I-S), Depression (DEP), Anxiety (ANX), Hostility (HOS), Phobic anxiety (PHOB), Paranoid ideation (PAR) and Psychotics (PSY). For this study we used a total BSI score as a measure of distress. The maximum score is 159 and a range of 0 to 159 with higher scores indicating more psychological distress.
Posttraumatic stress disorder checklist - Civilian (PCL-C)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 70 participants 69 participants 139 participants
38.01  (15.21) 40.61  (16.04) 39.28  (15.62)
[1]
Measure Description: The PCL-C is a standardized self-report rating scale for Posttraumatic Stress disorder symptoms (PTSD). The maximum score is 85 with a range of 17 to 85. Higher scores indicate increased PTSD symptoms. A cut-off of 50 has good sesnitivity and specificty for PTSD.
1.Primary Outcome
Title The Number of Alcohol Drinks Per Week (as Measured by the Time Line Follow Back Procedure) at the 6 Month Follow-up.
Hide Description 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.
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:

Motivational enhancement therapy

Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH.

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 Number of Participants Analyzed 70 68
Mean (Standard Deviation)
Unit of Measure: Standard Alcohol drinks
14.88  (27.94) 21.41  (29.39)
2.Primary Outcome
Title Percent Days Abstinent From Alcohol at 6 Months
Hide Description Alcohol 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.
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:

Motivational enhancement therapy

Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH.

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 Number of Participants Analyzed 70 68
Mean (Standard Deviation)
Unit of Measure: percentage of days abstinent
73.15  (32.18) 59.49  (35.30)
3.Secondary Outcome
Title Heavy Drinking Days (Greater or Equal to 4 Drinks)
Hide Description This 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.
Time Frame 6-months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:

Motivational enhancement therapy

Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH.

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 Number of Participants Analyzed 70 68
Mean (Standard Deviation)
Unit of Measure: heavy drinking days
5.10  (8.1) 7.38  (9.53)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description

Motivational enhancement therapy

Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH.

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.

All-Cause Mortality
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/70 (10.00%)      14/69 (20.29%)    
Cardiac disorders     
myocardial infarction [1]  1/70 (1.43%)  1 0/69 (0.00%)  0
chest pain [2]  0/70 (0.00%)  0 1/69 (1.45%)  1
Hepatobiliary disorders     
Liver failure * [1]  1/70 (1.43%)  1 3/69 (4.35%)  3
GI distress [2]  1/70 (1.43%)  1 3/69 (4.35%)  3
Musculoskeletal and connective tissue disorders     
fracture [2]  1/70 (1.43%)  1 1/69 (1.45%)  1
Psychiatric disorders     
psychiatric symptoms * [2]  1/70 (1.43%)  1 2/69 (2.90%)  2
Alcohol intoxication * [2]  2/70 (2.86%)  2 4/69 (5.80%)  4
*
Indicates events were collected by non-systematic assessment
[1]
Death
[2]
Hospitalization
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 Arm 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/70 (0.00%)      0/69 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eric Dieperink, MD
Organization: VAMC
Phone: 612-467-3964
EMail: eric.dieperink@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00596960     History of Changes
Other Study ID Numbers: NEUA-009-07S
First Submitted: January 8, 2008
First Posted: January 17, 2008
Results First Submitted: November 12, 2014
Results First Posted: November 28, 2014
Last Update Posted: November 28, 2014