Trial Outcomes & Findings for Health Focused Motivational Treatment for Alcohol Dependent Veterans (NCT NCT00252590)

NCT ID: NCT00252590

Last Updated: 2016-03-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 99 participants
• Primary outcome timeframe: 4 months
• Results posted on: 2016-03-21

Participant Flow

Participant milestones

Measure	Health Motivational Feedback Personalized health-related feedback Health Motivational Feedback: Personalized feedback on health status provided in four once monthly 45 minute sessions. Information for feedback was attained with assessments and blood serum testing.	Health Education Non-personalized didactic health-related education Health Education: Generalized health education related to alcohol use provided in four once monthly 45-minute sessions. Topics for sessions include sleep, pain, cardiovascular health, and gastrointestinal health.	Control - Treatment as Usual No added treatment control Control - treatment as usual: Control group with no additional intervention
Overall Study STARTED	35	30	34
Overall Study COMPLETED	33	28	31
Overall Study NOT COMPLETED	2	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Health Focused Motivational Treatment for Alcohol Dependent Veterans

Baseline characteristics by cohort

Measure	Health Motivational Feedback n=35 Participants Personalized health-related feedback Health Motivational Feedback: Personalized feedback on health status	Health Education n=30 Participants Non-personalized didactic health-related education Health Education: Generalized health education related to alcohol use	Control - Treatment as Usual n=34 Participants No added treatment control Control - treatment as usual: Control group with no additional intervention	Total n=99 Participants Total of all reporting groups
Age, Continuous	48.1 years STANDARD_DEVIATION 11.0 • n=5 Participants	49.4 years STANDARD_DEVIATION 8.2 • n=7 Participants	49.1 years STANDARD_DEVIATION 11.7 • n=5 Participants	48.8 years STANDARD_DEVIATION 10.4 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	27 Participants n=7 Participants	32 Participants n=5 Participants	90 Participants n=4 Participants
Region of Enrollment United States	35 participants n=5 Participants	30 participants n=7 Participants	34 participants n=5 Participants	99 participants n=4 Participants
Percentage Days Abstinent all substances	48.6 percentage STANDARD_DEVIATION 31.5 • n=5 Participants	59.6 percentage STANDARD_DEVIATION 32.0 • n=7 Participants	47.4 percentage STANDARD_DEVIATION 29.2 • n=5 Participants	51.5 percentage STANDARD_DEVIATION 31.0 • n=4 Participants
Percentage Days Abstinent alcohol	49.1 percentage STANDARD_DEVIATION 31.0 • n=5 Participants	60.1 percentage STANDARD_DEVIATION 31.9 • n=7 Participants	48.2 percentage STANDARD_DEVIATION 28.8 • n=5 Participants	52.1 percentage STANDARD_DEVIATION 30.7 • n=4 Participants

PRIMARY outcome

Timeframe: 4 months

Outcome measures

Measure	Health Motivational Feedback n=33 Participants Personalized health-related feedback Health Motivational Feedback: Personalized feedback on health status	Health Education n=28 Participants Non-personalized didactic health-related education Health Education: Generalized health education related to alcohol use	Control - Treatment as Usual n=31 Participants No added treatment control Control - treatment as usual: Control group with no additional intervention
Percentage of Days Abstinent From Alcohol	91.4 percentage of days abstinent alcohol Standard Deviation 14.2	87.3 percentage of days abstinent alcohol Standard Deviation 23.6	83.0 percentage of days abstinent alcohol Standard Deviation 26.8

SECONDARY outcome

Timeframe: 4 months

Percentage of days abstinent from both alcohol and drugs

Outcome measures

Measure	Health Motivational Feedback n=33 Participants Personalized health-related feedback Health Motivational Feedback: Personalized feedback on health status	Health Education n=28 Participants Non-personalized didactic health-related education Health Education: Generalized health education related to alcohol use	Control - Treatment as Usual n=31 Participants No added treatment control Control - treatment as usual: Control group with no additional intervention
Percentage of Days Abstinent From All Substances	91.2 percentage of days abstinent Standard Deviation 14.2	84.1 percentage of days abstinent Standard Deviation 27.8	82.1 percentage of days abstinent Standard Deviation 26.7

Adverse Events

Health Motivational Feedback

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Health Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control - Treatment as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Health Motivational Feedback n=35 participants at risk Personalized health-related feedback Health Motivational Feedback: Personalized feedback on health status	Health Education n=30 participants at risk Non-personalized didactic health-related education Health Education: Generalized health education related to alcohol use	Control - Treatment as Usual n=34 participants at risk No added treatment control Control - treatment as usual: Control group with no additional intervention
Psychiatric disorders Inpatient psychiatric hospital admission	2.9% 1/35 • Number of events 1 • 3 years, 8 months	0.00% 0/30 • 3 years, 8 months	0.00% 0/34 • 3 years, 8 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Susan Tate

VA San Diego Healthcare/University of California, San Diego

Phone: 619-426-9402

Email: srtate@ucsd.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place