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Brief Alcohol Treatment for Women Veterans in Primary Care - Open Trial

ConditionUnhealthy Alcohol Use
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 an open trial phase to test the intervention with a small number of participants and revise the intervention based on experience and feedback. 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 deliver the intervention to women Veterans with unhealthy alcohol use in primary care. Participants will be asked to participate in the new behavioral treatment and attend 2 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 volunteers

Qualifiers

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

Single group

Treatments tested in this trial

  • Brief, Integrated Intervention for Women Veterans with Unhealthy Alcohol Use in Primary Care

    Behavioral

    The intervention consists of 4-9 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 5 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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Brief intervention for unhealthy alcohol useExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in self-reported quality of life from baseline to 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. Higher scores indicate better quality of life.

Time frame
Baseline to post-treatment (approximately 8-12 weeks after baseline)
2

Change in self-reported alcohol-related problems from baseline to 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. Higher scores indicate more frequent alcohol-related problems.

Time frame
From baseline to post-treatment (approximately 8-12 weeks after baseline)
3

Change in self-reported alcohol-related functional impairment from baseline to 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. Higher scores indicate greater alcohol-related functional impairment.

Time frame
Baseline to post-treatment (approximately 8-12 weeks after baseline)
4

Feasibility - average session length

Length of sessions 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, 8-18 weeks post-baseline

Secondary outcomes

1

Self-reported change in alcohol consumption from baseline to 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 post-treatment (approximately 8-12 weeks after baseline).

Other outcomes

Locations

This trial has no locations.

Sponsors 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: