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

540 Participants Needed

Trial Summary

What is the purpose of this trial?

The transition from high school to college is a developmentally sensitive period that is high risk for escalations in alcohol use. Although risky drinking is a common problem among freshmen, engagement in treatment services is very low. The proposed study will test a behavioral activation intervention that addresses factors limiting participation in standard treatment services by targeting alcohol use indirectly, by directly addressing concerns most relevant to incoming college freshmen, and by integrating an intervention into the college curriculum.

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 data supports the effectiveness of the treatment Behavioral Activation for Alcohol Use Disorder?

Behavioral Activation (BA) is a well-supported treatment for depression and has been shown to help increase positive activities and reduce avoidance behaviors, which are common in many mental health issues. While specific data for alcohol use disorder is limited, BA's success in enhancing positive reinforcement and reducing negative mental states in other conditions suggests it could be beneficial for alcohol use disorder as well. ^{1 2 3 4 5}

Is Behavioral Activation Therapy safe for humans?

In a study of psychosocial treatments for substance abuse, including alcohol use disorder, no serious adverse events were found to be related to the therapy itself, suggesting that these types of behavioral interventions are generally safe. ^{4 6 7 8 9}

How is Behavioral Activation Intervention different from other treatments for Alcohol Use Disorder?

Behavioral Activation Intervention is unique because it focuses on increasing engagement in positive activities and reducing avoidance behaviors, which can help improve mood and motivation. This approach is different from other treatments that may focus more on cognitive restructuring or motivational interviewing. ^{1 4 5 6 10}

Research Team

Tera L Fazzino, PhD

Principal Investigator

University of Kansas

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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]

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]

References

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

What is behavioral activation? A review of the empirical literature. [2022]

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

Behavioral activation: a strategy to enhance treatment response. [2014]

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

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

4. England 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. [2019]

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

Behavioral activation strategies for major depression in transdiagnostic cognitive-behavioral therapy: An evidence-based case study. [2019]

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

Behavioral therapy across the spectrum. [2021]

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

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? [2021]

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

Training, supervision and quality monitoring of the COMBINE Study behavioral interventions. [2019]

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

Evaluation of Drinking Risk Levels as Outcomes in Alcohol Pharmacotherapy Trials: A Secondary Analysis of 3 Randomized Clinical Trials. [2022]

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

Cognitive-behavioral treatment with behavioral activation for smoking cessation: Randomized controlled trial. [2020]