Cognitive Behavioral Therapy for Alcoholism

Overseen By Madeleine P Stein, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Suicidal, Psychotic, Manic, Pregnant

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 12 months

162 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate a Female-Specific Cognitive Behavioral Therapy (CBT) Group as treatment for Alcohol Use Disorder among Veteran women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is Female-Specific Cognitive Behavioral Therapy (FS-CBT) safe for treating alcohol use disorder in women?

Research on Female-Specific Cognitive Behavioral Therapy (FS-CBT) for women with alcohol use disorder shows that participants were highly engaged and satisfied with the treatment, with no reported safety concerns. This suggests that FS-CBT is generally safe for use in humans. ^{1 2 3 4 5}

How is Female-Specific Cognitive Behavioral Therapy (FS-CBT) different from other treatments for alcohol use disorder?

FS-CBT is unique because it specifically addresses issues common among women with alcohol use disorder, such as anxiety, depression, and social networks supportive of abstinence, which are not typically targeted in gender-neutral therapies. It also showed an increase in the percentage of abstainers in women's social networks after treatment, which was not observed in standard CBT. ^{1 4 5 6 7}

What data supports the effectiveness of the treatment Female-Specific Cognitive Behavioral Therapy (FS-CBT) for alcoholism?

Research shows that Female-Specific Cognitive Behavioral Therapy (FS-CBT) is as effective as standard gender-neutral CBT in reducing alcohol consumption among women with alcohol use disorder. Additionally, women who received FS-CBT reported an increase in abstainers within their social networks, suggesting a positive social influence on maintaining sobriety. ^{1 3 4 5 6}

Who Is on the Research Team?

Elizabeth E Epstein, PHD

Principal Investigator

University of Massachusetts Chan Medical School

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a woman.

You have a score of 3 or higher on the AUDIT-C questionnaire and have been diagnosed with Alcohol Use Disorder (AUD) after a more detailed screening.

Proficient in speaking and reading English at the 8th grade level

Exclusion Criteria

You are currently feeling extremely sad or upset and may be thinking about hurting yourself, or you are experiencing severe mental illness symptoms such as hallucinations or extreme mood swings.

Pregnant women

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Female-Specific Cognitive Behavioral Therapy (FS-CBT) or Usual Care for Alcohol Use Disorder

12 months

12 sessions for FS-CBT, variable for Usual Care

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

3 visits (in-person or virtual) at 3-, 9-, and 15-months post-baseline

Implementation Evaluation

Evaluation of implementation barriers and facilitators using qualitative interviews and quantitative data

Throughout the trial

What Are the Treatments Tested in This Trial?

Interventions

• Female-Specific Cognitive Behavioral Therapy (FS-CBT)
• Usual Care

Trial Overview 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.

How Is the Trial Designed?

Group I: Female-Specific Cognitive Behavioral Therapy Experimental Treatment 2 Interventions

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

Group II: Usual Care Active Control 1 Intervention

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

Female-Specific Cognitive Behavioral Therapy (FS-CBT) is already approved in United States for the following indications:

Approved in United States as Female-Specific Cognitive Behavioral Therapy for:

• Alcohol Use Disorder

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Group-based Female-Specific Cognitive Behavioral Therapy (G-FS-CBT) is feasible and acceptable for women with Alcohol Use Disorder (AUD), showing similar effectiveness to individual therapy (I-FS-CBT) in reducing drinking days and improving mental health outcomes.

Both treatment formats resulted in significant improvements in depression, anxiety, and interpersonal problems, with gains maintained at a 12-month follow-up, indicating that G-FS-CBT can be a valuable community-friendly option for women seeking help for AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual versus group female-specific cognitive behavior therapy for alcohol use disorder. Epstein, EE., McCrady, BS., Hallgren, KA., et al.[2021]

In a study involving 99 women with alcohol use disorder, Female-Specific Cognitive Behavioral Therapy (FS-CBT) showed similar effectiveness to gender-neutral CBT (GN-CBT) in reducing drinking and improving related psychological factors over 15 months.

Women receiving FS-CBT reported a significant increase in the percentage of abstainers in their social networks after treatment, suggesting that FS-CBT may enhance social support for abstinence, which is crucial for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of female-specific cognitive behavior therapy for alcohol dependent women. Epstein, EE., McCrady, BS., Hallgren, KA., et al.[2021]

In a study involving 99 women with alcohol use disorders, both Female-Specific Cognitive Behavioral Therapy (FS-CBT) and Gender-Neutral CBT (GN-CBT) were effective in reducing alcohol consumption by enhancing coping skills and confidence to abstain from drinking.

FS-CBT uniquely addressed female-specific factors such as sociotropy and social support, leading to additional improvements in abstinence, while GN-CBT showed that changes in depression were crucial for treatment success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanisms of change in female-specific and gender-neutral cognitive behavioral therapy for women with alcohol use disorder. Holzhauer, CG., Hildebrandt, T., Epstein, E., et al.[2021]

Alcohol-dependent women often exhibit unique characteristics such as solitary drinking, neurotic issues, early health risks, and co-abuse of other drugs, which should be considered in their treatment.

The in-patient program designed for these women incorporates a therapeutic community approach with various therapies and interventions, including group therapy, family therapy, and the use of medications like disulfiram, highlighting the need for tailored treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment needs of alcohol-dependent women. Nespor, K.[2005]

Effective treatment for women with alcohol problems requires recognizing and addressing specific risk factors and consequences related to women's drinking behaviors.

Women-sensitive treatment components can be successfully integrated into both mixed-gender and women-only treatment programs, enhancing the effectiveness of interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Needs for Women With Alcohol Problems. Beckman, LJ.[2023]

A meta-analysis of 22 studies involving 1,317 women and 4,794 men found that acamprosate significantly improves abstinence rates and reduces heavy drinking days in both sexes, with a notable increase in treatment completion and medication compliance compared to placebo.

There were no significant differences in efficacy, safety, or tolerability of acamprosate between men and women, indicating that both genders can benefit equally from this treatment for alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acamprosate for alcohol dependence: a sex-specific meta-analysis based on individual patient data. Mason, BJ., Lehert, P.[2021]

In a study of 406 alcohol use disorder patients (103 females and 303 males) undergoing 20-22 sessions of behavioral couples therapy (BCT), both genders showed significant improvements in drinking outcomes and relationship adjustment over a 12-month follow-up, indicating the efficacy of BCT for both sexes.

Despite some gender differences in initial clinical problems, such as emotional distress and drinking severity, these did not affect the overall treatment outcomes, suggesting that BCT is equally effective for both female and male patients with alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do outcomes after behavioral couples therapy differ based on the gender of the alcohol use disorder patient? O'Farrell, TJ., Schreiner, A., Schumm, J., et al.[2018]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Individual versus group female-specific cognitive behavior therapy for alcohol use disorder. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of female-specific cognitive behavior therapy for alcohol dependent women. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Mechanisms of change in female-specific and gender-neutral cognitive behavioral therapy for women with alcohol use disorder. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Treatment needs of alcohol-dependent women. [2005]

5. United States pubmed.ncbi.nlm.nih.gov

Treatment Needs for Women With Alcohol Problems. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Acamprosate for alcohol dependence: a sex-specific meta-analysis based on individual patient data. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Do outcomes after behavioral couples therapy differ based on the gender of the alcohol use disorder patient? [2018]