Brief Alcohol Treatment for Women Veterans in Primary Care
ConditionAlcohol Misuse
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSyracuse VA Medical Center
About this trial
The goal of this study is to develop and test a brief behavioral treatment for women Veterans with alcohol use in primary care. The study involves a development phase, an open trial phase, and a pilot randomized controlled trial. The main questions it aims to answer are:
* Is the treatment feasible and acceptable to women Veteran primary care patients? * Can the treatment help reduce alcohol use, alcohol-related problems, and improve quality of life? Researchers will compare the new treatment to usual treatment that primary care patients would normally receive. Participants will be asked to participate in either the new behavioral treatment or usual primary care treatment and attend 3 appointments to answer questions about their alcohol use, quality of life, other mental health symptoms, and what they thought of their behavioral treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Veteran status
past-year Syracuse VAMC or community-based outpatient clinic (CBOC) primary care appointment
identify as woman OR use women's PC services
unhealthy alcohol use (AUDIT ≥ 7)
Disqualifiers
current substance use treatment outside PC
current psychosis, mania, or dementia (>10 on the BOMC)
need for a higher level of alcohol or substance use care (detoxification, residential treatment) as indicated by a) patient preference b) withdrawal symptoms that indicate a need to monitor (≥23 on the AWSC) or high risk substance use (≥27 on the ASSIST)
imminent risk of suicide.
Trial design
Design model
Parallel
Treatments tested in this trial
Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary Care
BehavioralThe intervention consists of 4-6 30-minute behavioral health appointments with a behavioral health provider in an integrated primary care setting. It includes 4 core alcohol-focused appointments focused on providing information and skills to manage unhealthy alcohol use that have been adapted from existing evidence-based treatments in integrated primary care and specialty care. Participants may elect to attend up to 2 additional optional appointments focused on supplemental strategies to manage alcohol use or to address co-occurring mental and behavioral health concerns, including mood, trauma, sleep, and pain.
Primary care usual care
BehavioralPrimary care usual care consists of universal annual alcohol screening; those who are identified as at-risk receive a brief advice intervention from their primary care provider and may be offered an integrated primary care referral. The brief advice intervention is standardized and triggered automatically by a positive screen. Integrated primary care consists of brief assessment and intervention with licensed, independent behavioral health providers. Patients may decline integrated primary care referrals, complete several appointments, and/or be referred to specialty treatment
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Brief intervention for unhealthy alcohol useExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in self-reported quality of life from baseline to 6-months post-treatment
Quality of life will be assessed by the abbreviated World Health Organization Quality of Life Assessment (WHOQOL-BREF), a 26-item self-report measure of QoL in the past 2 weeks in 4 areas (social, physical, psychological, and environment) on a 1-5 scale.
Time frame
From baseline to 6 months post-treatment2
Change in self-reported alcohol-related problems from baseline to 6 months post-treatment
Alcohol problems will be assessed by the Short Inventory of Problems-Revised (SIP-R)147, a 17-item self-report measure of frequency of alcohol problems on a 0-3 scale.
Time frame
From baseline to 6 months post-treatment3
Change in self-reported alcohol-related functional impairment from baseline to 6 months post-treatment
Alcohol-specific functional impairment will be assessed by the Addiction Severity Index - Lite, a semi-structured interview developed among Veterans in substance use treatment that assesses alcohol and drug use and problems and 5 areas of functioning: medical, legal, psychiatric, employment, and family/social
Time frame
Baseline to 6 months post-treatment4
Feasibility - average session length
Length of sessions in the experimental condition will be measured to test if the average is within guidelines for integrated primary care treatment (30 minutes maximum).
Time frame
For the duration of the intervention period, 8-12 weeks post-baseline.Secondary outcomes
1
Self-reported change in alcohol consumption from baseline to 6 months post-treatment
Alcohol use will be assessed with the Timeline Followback (TLFB), a calendar-based measure that records standard drinks consumed each day in the past month to yield percent of drinking days, average drinks per drinking day, percent of heavy drinking (i.e., ≥4 drinks/occasion) days, and a variable indicating if alcohol use is above NIAAA-recommendations.
Time frame
Baseline to 6 months post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Syracuse VA Medical Center
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: