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Behavioral Intervention

Cognitive Behavioral Therapy for Alcoholism

N/A

Recruiting

Led By Elizabeth E Epstein, PHD

Research Sponsored by University of Massachusetts, Worcester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up

Awards & highlights

Study Summary

This trial tests a CBT group to treat alcohol use disorder in female veterans.

Who is the study for?

This trial is for U.S. Veteran women aged 18 or older with Alcohol Use Disorder (AUD) who have consumed alcohol within the last 90 days and are enrolled in healthcare at VA New York Harbor Healthcare System. They must speak and read English well. Pregnant women, prisoners, or those acutely suicidal or with severe mental illness symptoms are excluded.Check my eligibility

What is being tested?

The study is testing a Female-Specific Cognitive Behavioral Therapy (FS-CBT) designed for Veteran women with AUD against usual care practices to see if FS-CBT is more effective in treating their condition.See study design

What are the potential side effects?

Since this trial involves therapy rather than medication, there may not be physical side effects like those from drugs; however, participants might experience emotional discomfort discussing personal issues during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, and 3-, 9-, and 15-months post-baseline follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Alcohol Use Disorders Identification Test (AUDIT)

Electronic Medical Record (EMR)

Form 90 Timeline Followback (TLFB)

+2 more

Secondary outcome measures

Coping Strategies Scale (CSS)

Difficulties in Emotion Regulation Scale (DERS)

Important People Interview (IPI)

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Female-Specific Cognitive Behavioral TherapyExperimental Treatment2 Interventions

Participants in this arm will receive female-specific cognitive behavioral therapy and usual VA care for alcohol use disorder.

Group II: Usual CareActive Control1 Intervention

Participants in this arm will receive usual VA care for alcohol use disorder.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Usual Care

1990

Completed Phase 4

~7700

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Massachusetts, WorcesterLead Sponsor

343 Previous Clinical Trials

986,448 Total Patients Enrolled

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

802 Previous Clinical Trials

1,365,283 Total Patients Enrolled

1 Trials studying Risky Health Behavior

183 Patients Enrolled for Risky Health Behavior

Elizabeth E Epstein, PHDPrincipal InvestigatorUniversity of Massachusetts Chan Medical School

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are participating in this research experiment?

"Affirmative. According to the information on clinicaltrials.gov, this research study is still actively recruiting participants. It was first publicized online on December 16th 2022 and recently updated on October 31st 2023. The team behind it needs 162 patients from 1 trial centre sites."

Answered by AI

Is this research currently recruiting participants?

"Affirmative. Clinicaltrials.gov reveals that the trial, which was first posted on December 16th 2022, is actively searching for participants and it's most recent update occured in October 31st 2023."

Answered by AI

What are the intended outcomes of this medical investigation?

"The primary end point of this medical trial, which will be evaluated at initiation and 3-, 9- and 15-months post baseline follow up is SCID (Structured Clinical Interview for DSM Disorders) Alcohol Use Disorder Module. Additionally, the evaluation includes PCL (posttraumatic stress disorder checklist)-5 with LEC (life events checklist)-5, DERS (Difficulties in Emotion Regulation Scale), a self-report questionnaire that gauges emotion regulation ability; as well as CSS (Coping Strategies Scale), another self-report measure employed to check coping strategies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Female-Specific CBT Group for Veteran Women With Alcohol Use Disorder in VA Primary Care Settings

Elizabeth Epstein 2023. "A Female-Specific CBT Group for Veteran Women With Alcohol Use Disorder in VA Primary Care Settings". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06118346.