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?

This trial tests a special therapy called Female-Specific Cognitive Behavioral Therapy (FS-CBT) to determine its effectiveness for women veterans with Alcohol Use Disorder. The researchers aim to compare the effects of FS-CBT with the usual care provided by the VA. Women veterans enrolled in VA healthcare with a history of drinking beyond recommended limits might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance care for women veterans.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Female-Specific Cognitive Behavioral Therapy (FS-CBT) is a safe treatment for women with Alcohol Use Disorder. In earlier studies, women who tried FS-CBT experienced very few side effects. Most participants handled the therapy well, and researchers reported no major problems. This suggests that FS-CBT is a good option for women seeking help with alcohol use issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Female-Specific Cognitive Behavioral Therapy (FS-CBT) for alcoholism because it tailors the treatment to address unique challenges and experiences faced by women with alcohol use disorder. Unlike standard cognitive behavioral therapies, which are more generalized, FS-CBT incorporates gender-specific factors such as social roles, relationships, and biological differences, making it more personalized and potentially more effective for women. This targeted approach aims to improve engagement and outcomes by addressing the specific needs and triggers women may experience, which are often overlooked in traditional treatment programs.

What evidence suggests that this trial's treatments could be effective for alcohol use disorder?

Research has shown that Female-Specific Cognitive Behavioral Therapy (FS-CBT) can assist women with Alcohol Use Disorder (AUD). In this trial, one group of participants will receive FS-CBT alongside usual VA care. A study found that women who received FS-CBT reduced their alcohol use more effectively than those who received a more general therapy. This suggests that therapy tailored to the unique challenges women face can lead to better outcomes. FS-CBT also addresses issues specific to women, potentially creating a more supportive environment that enhances engagement and recovery. Overall, FS-CBT appears to be a promising treatment option for women dealing with AUD. ^{1 4 6 7 8}

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.

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

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.

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

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30898323/

Cost-effectiveness of individual versus group female-specific ... Cost-effectiveness of individual versus group female-specific cognitive behavioral therapy for alcohol use disorder ... J Subst Abuse Treat. 2019 May:100:1-7. doi ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5805606/

A Randomized Trial of Female-Specific Cognitive Behavior ... This study compared Female-Specific Cognitive Behavioral Therapy (FS-CBT) to evidence-based, gender neutral CBT (GN-CBT; Epstein & McCrady, 2009) for women ...

3. psycnet.apa.org psycnet.apa.org/record/2017-51830-001

A randomized trial of female-specific cognitive behavior ... This study compared Female-Specific Cognitive Behavioral Therapy (FS-CBT) to evidence-based, gender-neutral CBT (GN-CBT; Epstein & McCrady, 2009) for women ...

4. jsatjournal.com jsatjournal.com/article/S0740-5472(17)30509-3/abstract

Individual versus group female-specific cognitive behavior ... Objectives. To test group-based Female-Specific Cognitive Behavioral Therapy (G-FS-CBT) for women with Alcohol Use Disorder (AUD) against ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2824103

A Digital Cognitive Behavioral Therapy Program for Adults ... Findings In this randomized clinical trial with 99 participants seeking treatment for alcohol use disorder, those assigned to digital CBT plus ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6424104/

Individual versus Group Female-Specific Cognitive ... To test group-based Female-Specific Cognitive Behavioral Therapy (G-FS-CBT) for women with Alcohol Use Disorder (AUD) against an individual Female-Specific ...

7. lbj.utexas.edu lbj.utexas.edu/cost-effectiveness-individual-versus-group-female-specific-cognitive-behavioral-therapy-alcohol-use

Cost-effectiveness of individual versus group female-specific ... ... female-specific cognitive behavioral therapy for alcohol use disorder. Article, Refereed Journal. Journal of Substance Abuse Treatment. Cover of the Journal of ...

8. researchgate.net researchgate.net/publication/323339347_Individual_versus_group_female-specific_cognitive_behavior_therapy_for_alcohol_use_disorder

(PDF) Individual versus group female-specific cognitive ... PDF | Objectives To test group-based Female-Specific Cognitive Behavioral Therapy (G-FS-CBT) for women with Alcohol Use Disorder (AUD) against an.