Brief Alcohol Treatment for Women Veterans in Primary Care

N/ANot Yet RecruitingNCT07414589

Syracuse VA Medical Center70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Alcohol Misuse

Interventions

The 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 careBEHAVIORAL

Primary 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

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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) Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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-treatment

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-treatment

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-treatment

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.

Intervention fidelity

An independent rater will listen to session tapes and record if each essential element was delivered on a checklist.

Time frame: For the duration of the intervention period, 8-12 weeks post-baseline.

Self-reported patient acceptability of the experimental intervention

Patient acceptability will be assessed with the Client Satisfaction Questionnaire (CSQ), an 8-item self-report measure. Acceptability ratings of at least "moderate" on the majority (5/8) of items on the CSQ will be considered acceptable.

Time frame: After completing the behavioral health treatment, 8-12 weeks post-baseline.

Secondary Outcomes

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.