Behavioral Activation for Alcohol Use Disorder

Overseen By Carl W Lejuez, PhD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Kansas

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help college freshmen reduce risky drinking habits through a new approach called Behavioral Activation, a type of therapy. The focus is on addressing issues that matter most to new college students by integrating this intervention into their existing orientation courses. Participants will either attend a standard freshman course or one that includes the new Behavioral Activation strategy. Freshmen enrolled in a seminar course at the University of Kansas might be eligible to join this trial. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Will I have to stop taking my current medications?

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

What prior data suggests that this behavioral activation intervention is safe for college freshmen?

Research shows that behavioral activation treatments are generally manageable for people with alcohol use problems. Studies have found these treatments effective and well-received by adults dealing with alcohol and drug issues. Past participants reported feeling better with few negative effects.

In other studies focused on alcohol use, participants felt more motivated and less unable to enjoy activities, indicating positive results without major side effects. While more research is needed, current evidence suggests that behavioral activation is a safe and promising option for addressing alcohol use, especially in high-risk groups like college students. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Behavioral Activation for Alcohol Use Disorder because it offers a fresh approach compared to traditional treatments like medication or talk therapy. This method focuses on helping individuals engage in positive activities to combat negative moods associated with alcohol use, potentially reducing the reliance on substances. By integrating this technique into settings like college freshman orientation seminars, it targets young adults at a critical time, aiming to prevent the development of long-term alcohol-related problems. This proactive and structured approach could offer more immediate and practical benefits, making it an appealing option for managing alcohol use disorder.

What evidence suggests that this Behavioral Activation Intervention is effective for Alcohol Use Disorder?

Research shows that Behavioral Activation (BA) can help reduce substance use, including alcohol. Studies have found that BA boosts positive feelings and lessens symptoms of depression and substance use. In this trial, some participants will receive a Behavioral Activation Course, which studies have shown significantly reduces heavy drinking compared to standard care. Another study found that BA increased the likelihood of staying sober and lessened the negative effects of substance use for up to a year after treatment. These findings suggest that BA might help college freshmen manage alcohol use by focusing on improving their overall well-being. ^{4 6 7 8 9}

Who Is on the Research Team?

Tera L Fazzino, PhD

Principal Investigator

University of Kansas

Are You a Good Fit for This Trial?

This trial is for college freshmen enrolled in UNIV 101 freshman seminar courses at the University of Kansas. It's designed to help students who are transitioning from high school to college and might be facing increased stress, which can lead to risky behaviors like heavy drinking or eating disorders.

Inclusion Criteria

College freshmen enrolled in UNIV 101 freshman seminar courses at the University of Kansas assigned to the study

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Behavioral Activation intervention administered in a semester-long freshman orientation course

16 weeks

Weekly sessions as part of the course

Post-treatment Assessment

Assessment of the durability of effects of the intervention

5 months

Follow-up

Participants are monitored for long-term effects of the intervention

17 months

1 visit at the end of sophomore year

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Activation Intervention

Trial Overview

The study is testing a behavioral activation intervention integrated into the college curriculum. This approach aims to reduce alcohol use and related issues by focusing on concerns relevant to new college students rather than directly targeting alcohol consumption itself.

How Is the Trial Designed?

Group I: Behavioral Activation Course Experimental Treatment 1 Intervention

Behavioral activation course condition administered in a college freshman orientation seminar

Group II: Standard Orientation Course Active Control 1 Intervention

Standard freshman orientation seminar course condition

Who Is Running the Clinical Trial?

University of Kansas

Lead Sponsor

Trials

157

Recruited

332,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Numerous effective behavioral therapies for alcohol abuse disorders can be delivered directly to patients, including individual, couples, and family therapies, as well as contingency management, making treatment more accessible.

Innovative delivery methods, such as computerized cognitive-behavioral treatments and mindfulness-based approaches, have shown good efficacy, but selecting the most suitable treatment for each patient remains a challenge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral therapy across the spectrum. Witkiewitz, K., Marlatt, A.[2021]

In a study involving 126 participants undergoing different therapies for alcohol use disorders, therapists who engaged in exploratory and connecting behaviors were more effective at encouraging clients to discuss positive changes in their drinking behavior.

Higher therapist skillfulness in exploring and connecting with clients significantly enhanced the effectiveness of these behaviors, leading to better client responses, while teaching behaviors were less effective in promoting discussions about change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapist and client discussions of drinking and coping: a sequential analysis of therapy dialogues in three evidence-based alcohol use disorder treatments. Magill, M., Walthers, J., Mastroleo, NR., et al.[2019]

Behavioral activation (BA) is an effective treatment for depression that focuses on increasing positive reinforcement in the environment to promote healthy behaviors and reduce avoidance.

BA can be integrated with other cognitive-behavioral strategies, making it versatile for various clinical populations and settings, highlighting its potential for broader application in treating emotional disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation strategies for major depression in transdiagnostic cognitive-behavioral therapy: An evidence-based case study. Farchione, TJ., Boswell, JF., Wilner, JG.[2019]

In a study involving 1,687 substance-abusing participants over 27,198 person-weeks, 12% experienced serious adverse events (SAEs), but none were deemed related to the psychosocial interventions being tested.

There were no significant differences in the incidence rates of SAEs between those receiving standard care and those receiving additional interventions like contingency management or motivational enhancement, suggesting that these psychosocial treatments are safe in terms of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? Petry, NM., Roll, JM., Rounsaville, BJ., et al.[2021]

The study involved 275 adult smokers and compared a smoking cessation treatment that included behavioral activation (SCBSCT-BA) with a standard cognitive-behavioral treatment (SCBSCT) and a wait-list control group, showing that SCBSCT-BA led to higher smoking abstinence rates at 12 months (30% vs. 18%).

Participants in the SCBSCT-BA group not only had better smoking cessation outcomes but also experienced significant reductions in depressive symptoms, highlighting the effectiveness of integrating behavioral activation into smoking cessation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral treatment with behavioral activation for smoking cessation: Randomized controlled trial. Martínez-Vispo, C., Rodríguez-Cano, R., López-Durán, A., et al.[2020]

Behavioral Activation (BA) is a well-supported psychotherapy for depression that has evolved over the years, incorporating various techniques such as activity monitoring, scheduling, and skills training, which have empirical support as effective components.

While some techniques like activity scheduling and relaxation training have been validated as effective on their own, others are more effective when used as part of a comprehensive treatment package, highlighting the importance of a tailored approach in BA interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is behavioral activation? A review of the empirical literature. Kanter, JW., Manos, RC., Bowe, WM., et al.[2022]

Behavioral activation is an effective treatment for depression that focuses on increasing engagement in pleasurable and meaningful activities, and it can be used alone or alongside antidepressant medications.

The method involves activity monitoring to help patients track their behaviors and moods, which aids in identifying patterns that contribute to their depression, making it a versatile approach even for those with other mental health issues like psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation: a strategy to enhance treatment response. Sudak, DM., Majeed, MH., Youngman, B.[2014]

In a study involving 1169 adults with alcohol dependence, outcomes based on WHO drinking risk level reductions were found to be more achievable and clinically meaningful compared to total abstinence or no heavy drinking days, suggesting they may better reflect patient goals.

The results indicated that while total abstinence was the least achieved outcome, WHO 1-level and 2-level reductions showed higher response rates, making them valuable indicators for evaluating the effectiveness of pharmacotherapy in treating alcohol use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Drinking Risk Levels as Outcomes in Alcohol Pharmacotherapy Trials: A Secondary Analysis of 3 Randomized Clinical Trials. Falk, DE., O'Malley, SS., Witkiewitz, K., et al.[2022]

Behavioral activation is an effective treatment for depression that focuses on increasing positive activities to counteract negative mental states, making it a fundamental mechanism for change in various psychological disorders.

This approach can be integrated into many forms of psychotherapy, potentially speeding up treatment and improving outcomes across a wide range of mental health issues, from chronic pain to personality disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral activation as a common mechanism of change across different orientations and disorders. Dimaggio, G., Shahar, G.[2018]

The COMBINE Study successfully implemented rigorous procedures to ensure treatment fidelity in behavioral interventions for alcohol dependence, involving careful screening, training, and supervision of practitioners.

Both the Medical Management (MM) and Combined Behavioral Intervention (CBI) were delivered with high fidelity, indicating that the interventions were consistently applied as intended, which is crucial for evaluating their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training, supervision and quality monitoring of the COMBINE Study behavioral interventions. Miller, WR., Moyers, TB., Arciniega, L., et al.[2019]

Citations

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Behavioral activation and value-consistency increased while anhedonia decreased in the intervention group. UBA warrants further investigation as ...