Cognitive Behavioral Therapy for Alcoholism

Overseen By Robert C Schlauch, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Disqualifiers: Acute psychosis, Severe cognitive impairment, Current drug use, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

250 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Cognitive-Behavioral Therapy for Alcoholism?

Research shows that Cognitive Behavioral Therapy (CBT) is a well-supported treatment for alcohol use disorders, with evidence suggesting it helps by improving coping skills. Studies have also explored delivering CBT through computer-based programs, which could make it more accessible and maintain its effectiveness. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy (CBT) safe for treating alcohol use disorders?

Cognitive Behavioral Therapy (CBT) is generally considered safe for treating alcohol use disorders, as it is a widely recognized and evidence-based psychological treatment. ^{1 2 5 6 7}

How is Cognitive Behavioral Therapy (CBT) different from other treatments for alcoholism?

Cognitive Behavioral Therapy (CBT) for alcoholism is unique because it focuses on teaching new coping skills and strategies to change behavior, and it can be delivered in various formats, including computer-based and internet-based programs, making it more accessible to those who may not seek traditional therapy. ^{1 2 3 5 8}

What is the purpose of this trial?

The goal of this single-arm clinical trial is to better understand the ways in which individuals seeking treatment recover from Alcohol Use Disorder (AUD). The main aims are to: * To establish operational definitions of types of change in relation to National Institute on Alcohol Abuse and Alcoholism's (NIAAA) new definition of recovery, and to distinguish between treatment response, remission versus recovery, and relapse versus recurrence. * To describe patterns of recovery, including the frequency of within-person transitions between types of change in clinical course to better understand the dynamic nature of recovery. * To examine the predictive relationships between theoretically important cognitive, behavioral, and affective process variables and changes during recovery, with a focus on how people initiate versus maintain change. Participants will: * Receive 12 weeks of psychotherapy for Alcohol Use Disorder * Complete brief assessments after each treatment session. * Complete brief assessments bi-weekly via phone for 1-year following treatment. * Complete in-person interviews at 3 or 6-month intervals post-treatment.

Eligibility Criteria

This trial is for individuals living close to the program site who have been diagnosed with Alcohol Use Disorder (AUD) and are able to give informed consent. They should not be legally required to attend treatment, must speak English well enough for consent procedures, and cannot have a current drug use diagnosis (except nicotine or marijuana), acute psychosis, or severe cognitive impairment.

Inclusion Criteria

Live within commuting distance of the program site

Provide informed consent

Current diagnosis of AUD (initial screening AUDIT ≥ 8, confirmed with diagnostic interview)

Exclusion Criteria

Current drug use diagnosis other than nicotine or marijuana use disorders

Acute psychosis or severe cognitive impairment (assessed via Psychotic Module of the M.I.N.I and Mini-Mental State ≤ 23)

Lack of sufficient familiarity with the English language to comprehend the recruitment and consent procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 weeks of psychotherapy for Alcohol Use Disorder

12 weeks

Weekly in-person sessions

Follow-up

Participants complete brief assessments bi-weekly via phone for 1-year following treatment and in-person interviews at 3 or 6-month intervals post-treatment

12 months

Bi-weekly phone assessments, in-person interviews at 3 and 6-month intervals

Long-term Follow-up

Participants are monitored at 3 and 6-month intervals for up to 24-54 months post-treatment depending on enrollment date

24-54 months

In-person interviews at 3 and 6-month intervals

Treatment Details

Interventions

• Cognitive-Behavioral Treatment

Trial Overview The study tests Cognitive-Behavioral Treatment over 12 weeks for AUD recovery. It aims to define types of change in recovery, describe patterns of recovery including frequency of transitions between changes, and examine predictive relationships between cognitive/behavioral/affective variables and changes during recovery.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Empirical supported psychotherapy for alcohol use disorder (Cognitive-Behavioral Therapy, Motivational Interviewing).

Cognitive-Behavioral Treatment is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for:

• Temporomandibular Disorders (TMD)
• Chronic Pain Management
• Depression

Approved in European Union as Cognitive Behavioural Therapy for:

• Temporomandibular Disorders (TMD)
• Chronic Pain Management
• Mental Health Conditions

Approved in Canada as Cognitive Behavioral Therapy for:

• Temporomandibular Disorders (TMD)
• Chronic Pain Management
• Anxiety Disorders

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

Findings from Research

A pilot study involving 13 participants showed that a therapist-guided internet-based cognitive behavior therapy (CBT) program significantly reduced alcohol consumption, with large effect sizes observed at the three-month follow-up.

Participants reported high satisfaction with the program, and improvements were also noted in craving, self-efficacy, depression, and quality of life, suggesting that this online treatment could be a viable option for individuals with alcohol use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity therapist-guided internet-based cognitive behavior therapy for alcohol use disorder: a pilot study. Sundström, C., Kraepelien, M., Eék, N., et al.[2018]

A study involving 68 individuals with alcohol use disorders showed that those receiving web-based cognitive behavioral therapy (CBT4CBT) had significantly higher treatment completion rates and greater increases in the percentage of days abstinent compared to standard treatment alone.

The web-based CBT4CBT program was found to be safe and feasible, with preliminary evidence suggesting it may reduce the costs of alcohol use disorder-related services compared to standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of Computerized Cognitive Behavioral Therapy for Alcohol Use Disorders: Efficacy as a Virtual Stand-Alone and Treatment Add-On Compared with Standard Outpatient Treatment. Kiluk, BD., Devore, KA., Buck, MB., et al.[2018]

A review of ten studies on cognitive-behavioral treatment (CBT) for alcohol dependence found little evidence supporting the idea that CBT works by enhancing coping skills.

The effectiveness of CBT in treating alcohol dependence remains unclear, suggesting that either previous studies had methodological issues or that the underlying assumptions of CBT may need to be reevaluated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral treatment for alcohol dependence: a review of evidence for its hypothesized mechanisms of action. Morgenstern, J., Longabaugh, R.[2019]

A four-year replication study of a medical behavioral treatment for alcoholism showed that patients receiving uniform treatment had a high probability of achieving and maintaining sobriety over time.

The study identified specific variables that may help predict which patients are more likely to succeed in treatment, emphasizing the importance of accurate diagnosis and referral in managing alcoholism effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Replicable abstinence rates in an alcoholism treatment program. Neubuerger, OW., Miller, SI., Schmitz, RE., et al.[2016]

A study involving 55 patients with alcohol use disorder showed that interactive, personalized computer-based cognitive behavioral therapy (CBT) was effective, leading to significant reductions in alcohol consumption and increased abstinence rates over a 3-month follow-up.

Both the computer-based CBT and placebo groups improved in their drinking outcomes, but the CBT group showed greater engagement in Alcoholics Anonymous and better self-efficacy regarding alcohol use, suggesting that computer-based CBT could be a valuable tool in treating AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerised cognitive behavioural therapy for alcohol use disorder: a pilot randomised control trial. Farren, CK., Milnes, J., Lambe, K., et al.[2019]

Cognitive-behavioral therapy (CBT) significantly reduces relapse rates in patients with alcohol dependence compared to standard treatment as usual (TAU), based on a study of 226 newly diagnosed patients.

Patients receiving CBT showed better outcomes within 6 months to 1 year, suggesting that CBT should be used as an important addition to traditional treatment methods for alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy as an adjuvant in management of alcohol dependence syndrome. Srivastava, K., Prakash, J., Bhat, PS., et al.[2022]

A study involving 63 participants found that adding computer-based cognitive behavioral therapy (CBT4CBT) to standard treatment for alcohol use disorder (AUD) was more effective and cost-effective than standard treatment alone, costing about $35.08 for each additional day of reduced drinking.

While CBT4CBT+monitoring was slightly less costly and more effective than standard treatment, overall treatment costs did not significantly differ across conditions, indicating that further research is needed to fully understand the cost-benefit of computer-delivered CBT for AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot economic evaluation of computerized cognitive behavioral therapy for alcohol use disorder as an addition and alternative to traditional therapy. Kacmarek, CN., Yates, BT., Nich, C., et al.[2023]

The cognitive-behavioral model for treating alcoholism focuses on social learning and conditioning, aiming to change behaviors by teaching new skills and avoidance strategies.

Therapies are tailored to individual or group needs, considering the patient's neuropsychological impairment and motivation, which helps in setting specific treatment goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive behavior therapy for the treatment of alcoholism]. Uehlinger, C.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

High-intensity therapist-guided internet-based cognitive behavior therapy for alcohol use disorder: a pilot study. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Randomized Trial of Computerized Cognitive Behavioral Therapy for Alcohol Use Disorders: Efficacy as a Virtual Stand-Alone and Treatment Add-On Compared with Standard Outpatient Treatment. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral treatment for alcohol dependence: a review of evidence for its hypothesized mechanisms of action. [2019]

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

Replicable abstinence rates in an alcoholism treatment program. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Computerised cognitive behavioural therapy for alcohol use disorder: a pilot randomised control trial. [2019]

6. India pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy as an adjuvant in management of alcohol dependence syndrome. [2022]

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

A pilot economic evaluation of computerized cognitive behavioral therapy for alcohol use disorder as an addition and alternative to traditional therapy. [2023]

8. France pubmed.ncbi.nlm.nih.gov

[Cognitive behavior therapy for the treatment of alcoholism]. [2018]