Internet-Based Cognitive Behavioral Therapy for Alcoholism

Overseen By Matt G Kushner, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Cognitive impairments, Serious suicide risk, others

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

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

256 Participants Needed

Trial Summary

What is the purpose of this trial?

This project is designed to determine if a computer-delivered cognitive-behavioral treatment can improve the otherwise poor alcohol use disorder treatment outcomes for individuals with a co-occurring anxiety disorder. In the past, the investigators showed that this treatment does improve outcomes for these individuals when delivered by a therapist. If the present work shows that the computer-delivered version is also effective, it would provide an inexpensive program with virtually unlimited scalability to enable access to the treatment by many more individuals than is currently the case.

Do I need to stop my current medications to join the trial?

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

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

Research shows that internet-delivered cognitive behavioral therapy (CBT) for alcohol misuse is effective, with most patients satisfied and finding it worth their time. Additionally, internet technology can enhance addiction treatment by improving accessibility and engagement, which supports the potential effectiveness of this online therapy. ^{1 2 3 4 5}

Is internet-based cognitive behavioral therapy (CBT) generally safe for humans?

The research does not provide specific safety data for internet-based CBT for alcoholism, but CBT is widely used and considered safe for treating various substance use disorders. ^{3 6 7 8 9}

How is the NEAT Program for alcoholism different from other treatments?

The NEAT Program is unique because it combines cognitive behavioral therapy (CBT) with a focus on managing negative emotions and addiction, and it is delivered over the internet, making it more accessible and cost-effective compared to traditional in-person therapy. ^{3 4 7 8 10}

Eligibility Criteria

This trial is for individuals with anxiety disorders like panic disorder, generalized anxiety disorder, or social anxiety disorder who are also seeking treatment for alcohol use. Participants must be able to read English at an eighth-grade level and be in a residential addiction program with enough time to complete the study.

Inclusion Criteria

Current (past 30 days) Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of panic disorder with or without agoraphobia (PD/Ag), generalized anxiety disorder (GAD) or social anxiety disorder (SAD)

Ability to provide informed consent

A minimum of an eighth grade English reading level

Exclusion Criteria

Serious suicide risk determined by study PI

I do not have any cognitive or medical conditions that prevent me from participating in studies.

Court-ordered treatment (The exclusion is based on its classification as a 'vulnerable' population.)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 28-day residential alcohol treatment program with either computer-delivered VC-CBT or an active control intervention

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 4, and 8 months

8 months

3 visits (virtual)

Treatment Details

Interventions

• Negative Emotions and Addiction Tools Program (NEAT)- Cognitive Behavioral Therapy
• Progressive Muscle Relaxation Training (PMRT)

Trial Overview The trial tests if cognitive-behavioral therapy (CBT) delivered via computer can help people with both an anxiety disorder and alcohol use issues. It compares the effectiveness of this method against Progressive Muscle Relaxation Training (PMRT).

Participant Groups

Group I: Experimental: Computer-delivered cognitive behavioral therapy hybrid for comorbidity Experimental Treatment 1 Intervention

Four, approximately 60 minute each, computerized therapy sessions delivered on an interactive computerized platform. All participants are undergoing a standard 28 day residential alcohol treatment program.

Group II: Treatment as Usual (TAU) Active Control 1 Intervention

Participants are undergoing a standard 28 day residential alcohol treatment program. No study intervention.

Group III: Control: Progressive Muscle Relaxation Training (PMRT) Active Control 1 Intervention

Four, one-hour computerized segments delivered on an interactive computerized platform teaching Progressive Muscle Relaxation Training (PMRT). All participants are undergoing a standard 28 day residential alcohol treatment program.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

A web-based cognitive-behavioral intervention for reducing substance use and depression was found to be feasible, showing significant reductions in substance use days, severity of use, and depressive symptoms across all treatment groups.

However, the web-based program was not more effective than traditional treatment methods, indicating that while it is a viable option, further research with larger samples is needed to fully assess its effectiveness and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Intervention to Reduce Substance Abuse and Depression: A Three Arm Randomized Trial in Mexico. Tiburcio, M., Lara, MA., Martínez, N., et al.[2019]

The Internet can significantly enhance addiction treatment by enabling efficient delivery of educational content and secure collection of self-reported data on substance use, making treatment more accessible and effective.

Internet applications support various aspects of addiction treatment, including assessment, monitoring patient outcomes, ongoing recovery support, and training for treatment providers, ultimately improving the quality of care and patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Internet technology can improve the quality of care for substance use disorders. Cucciare, MA., Weingardt, KR., Humphreys, K.[2019]

In a study of 140 adults with cocaine use disorder undergoing web-based cognitive-behavior therapy (CBT), higher baseline positive affect (PA) was linked to less frequent cocaine use during treatment, suggesting that enhancing positive emotions may improve treatment outcomes.

While negative affect (NA) scores decreased over time in both CBT and treatment as usual, higher NA during treatment was associated with increased cocaine use, indicating that managing negative emotions could be crucial for successful recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive and negative affect in cocaine use disorder treatment: Change across time and relevance to treatment outcome. Decker, SE., Morie, KP., Malin-Mayo, B., et al.[2020]

A study involving 191 patients who completed the Alcohol Change Course (ACC) showed that 69.6% were satisfied with the program, indicating its efficacy as an Internet-delivered cognitive behavior therapy for alcohol misuse.

Patients found skills like coping with cravings and managing risky situations particularly helpful, but many suggested increasing personal interaction and providing more information to enhance the course experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving internet-delivered cognitive behaviour therapy for alcohol misuse: Patient perspectives following program completion. Hadjistavropoulos, HD., Chadwick, C., Beck, CD., et al.[2021]

In a randomized clinical trial with 101 cocaine-dependent individuals on methadone, those who had access to computer-based cognitive-behavioral therapy (CBT4CBT) were significantly more likely to achieve 3 or more consecutive weeks of abstinence from cocaine (36% vs. 17%).

The study demonstrated that CBT4CBT not only improved immediate treatment outcomes but also showed durable effects, with continued improvement observed 6 months after treatment, highlighting its potential as an effective and easily disseminable adjunct to traditional addiction treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-assisted delivery of cognitive-behavioral therapy: efficacy and durability of CBT4CBT among cocaine-dependent individuals maintained on methadone. Carroll, KM., Kiluk, BD., Nich, C., et al.[2023]

The SPARX computerized cognitive behavioral therapy program is seen as a promising way to improve access to mental health treatment for rural youth in Australia, especially when it supports privacy and offers choices in how to access services.

Participants found the design features of SPARX, such as its narrative structure and personalization options, appealing, indicating that engaging design is crucial for acceptance, regardless of the program's New Zealand origins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Views of Young People in Rural Australia on SPARX, a Fantasy World Developed for New Zealand Youth With Depression. Cheek, C., Bridgman, H., Fleming, T., et al.[2020]

In a study of 1333 clients undergoing an 8-week internet-delivered cognitive behavioral therapy (ICBT) for depression and anxiety, only 10.8% reviewed a psychoeducational resource on alcohol use, but those who did found it beneficial, with 88.2% reporting it was worth their time.

Despite the resource being more frequently accessed by clients with higher alcohol-related difficulties, all clients showed reductions in alcohol consumption scores, depression, and anxiety over time, indicating that ICBT may help improve these issues, although reviewing the resource did not lead to greater reductions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impacts of a Psychoeducational Alcohol Resource During Internet-Delivered Cognitive Behavioral Therapy for Depression and Anxiety: Observational Study. Peynenburg, V., Sapkota, RP., Lozinski, T., et al.[2023]

The study evaluated the feasibility of a computer-based cognitive behavioral therapy program (CBT4CBT) as an addition to standard residential treatment for women with substance use disorders, involving 63 participants in total (34 in the CBT4CBT group and 29 in the treatment as usual group).

Results indicated that women using CBT4CBT showed a lower likelihood of relapse, longer time to relapse, and fewer days of substance use during the 12-week follow-up, suggesting that CBT4CBT could enhance treatment outcomes in residential settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized trial of CBT4CBT for women in residential treatment for substance use disorders. Kelpin, SS., Parlier-Ahmad, AB., Jallo, N., et al.[2022]

A computer-based simulation training program for cognitive behavioral therapy (CBT) significantly improved the skills of 65 graduate students in areas like agenda setting and explaining CBT concepts, compared to those using a manual training method.

While the simulation enhanced overall CBT skills, participants using the manual showed better improvement in assessing primary drug use, suggesting that both training methods have unique benefits for preparing trainees to work with clients with substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial testing of a computer-based simulation training module to support clinicians' acquisition of CBT skills for substance use disorder treatment. Mastroleo, NR., Humm, L., Williams, CM., et al.[2021]

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]

References

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

Web-Based Intervention to Reduce Substance Abuse and Depression: A Three Arm Randomized Trial in Mexico. [2019]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

How Internet technology can improve the quality of care for substance use disorders. [2019]

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

Positive and negative affect in cocaine use disorder treatment: Change across time and relevance to treatment outcome. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Improving internet-delivered cognitive behaviour therapy for alcohol misuse: Patient perspectives following program completion. [2021]

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

Computer-assisted delivery of cognitive-behavioral therapy: efficacy and durability of CBT4CBT among cocaine-dependent individuals maintained on methadone. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Views of Young People in Rural Australia on SPARX, a Fantasy World Developed for New Zealand Youth With Depression. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

The Impacts of a Psychoeducational Alcohol Resource During Internet-Delivered Cognitive Behavioral Therapy for Depression and Anxiety: Observational Study. [2023]

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

A pilot randomized trial of CBT4CBT for women in residential treatment for substance use disorders. [2022]

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

Initial testing of a computer-based simulation training module to support clinicians' acquisition of CBT skills for substance use disorder treatment. [2021]

10. 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]