Approach Avoidance Training for Alcohol Use Disorder

Recruiting in Palo Alto (17 mi)

Overseen by Jessica A Bomyea, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Psychotic, Bipolar, Neurodegenerative, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The proposed study will test a novel treatment for alcohol use disorders (AUD) to determine if it helps Veterans reduce their hazardous drinking and recover from alcohol-related functional impairments across social, occupational, and domestic domains. To do so, the investigators will evaluate clinical, cognitive, and neural effects of a computer-delivered Approach Avoidance Training (AAT) treatment - which changes implicit tendencies to approach alcohol-related cues - in conjunction with standard VA care. The project will support RR\&D's mission to improve Veterans' participation in their lives and community by determining if this innovative alternative technique can improve recovery outcomes for Veterans with AUD and exploring how the intervention works.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires a 4-week stability if you are on psychotropic medications (drugs that affect your mood, thoughts, or behavior).

What data supports the effectiveness of the treatment Approach Avoidance Training for Alcohol Use Disorder?

Preliminary evidence suggests that Approach Avoidance Training (AAT) can be a helpful addition to standard treatment for alcohol use disorder, as it targets the automatic tendency to approach alcohol-related cues. However, more research is needed to fully understand its effectiveness, especially in different settings and among individuals with other mental health conditions. ^{1 2 3 4 5}

Is Approach Avoidance Training (AAT) safe for humans?

The available research does not report any safety concerns for Approach Avoidance Training (AAT) in humans, suggesting it is generally safe to use. ^{1 2 6 7 8}

How is Approach Avoidance Training different from other treatments for alcohol use disorder?

Approach Avoidance Training (AAT) is unique because it uses cognitive training to help people change their automatic reactions to alcohol by encouraging them to 'avoid' alcohol-related cues and 'approach' neutral or positive ones. This can be done in a virtual reality setting or through a mobile app, making it more accessible and engaging compared to traditional therapies like cognitive-behavioral therapy or 12-step programs. ^{1 6 9 10 11}

Research Team

Jessica A Bomyea, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Eligibility Criteria

This trial is for English-speaking Veterans with Alcohol Use Disorder (AUD) who have been sober for no more than 90 days and are stable on any psychotropic medications for at least 4 weeks. It's not suitable for those with a history of severe mental health disorders, neurological conditions, sensory deficits, recent suicidal or homicidal thoughts, or anyone receiving concurrent psychotherapy outside standard care.

Inclusion Criteria

I have been diagnosed with alcohol use disorder and have not abstained from alcohol for more than 90 days.

Fluent in English

I have been diagnosed with alcohol use disorder and have not abstained from alcohol for more than 90 days.

Exclusion Criteria

Lifetime history of psychotic or bipolar disorder

Conditions unsafe for completing MRI scanning for those completing the scanning component only (e.g., metal in body)

I am currently receiving individual psychotherapy or treatments outside of standard programs.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Approach Avoidance Training (AAT) or Sham Training for 6 weeks to modify approach bias towards alcohol cues

6 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in alcohol use and functional recovery outcomes

6 months

Follow-up assessments at 3 and 6 months

Treatment Details

Interventions

• Approach Avoidance Training (Behavioral Intervention)

Trial Overview The study tests Approach Avoidance Training (AAT), a computer-based treatment aiming to alter the impulse to seek out alcohol-related cues. This is combined with standard VA care to see if it helps reduce drinking and improve social and occupational functioning in Veterans with AUD.

Participant Groups

Group I: Approach Avoidance Training Experimental Treatment 1 Intervention

AAT condition, participants use a joystick to respond to the color of the border surrounding the stimulus images presented (i.e., "pull for green, push for blue"). The stimuli used are alcohol-related images and neutral beverage images. To experimentally manipulate automatic action tendencies, a contingency is set between alcohol stimuli and avoidance behaviors

Group II: Sham Training Placebo Group 1 Intervention

In the Sham participants use a joystick to respond to the color of the border surrounding stimulus images presented. There is no contingency between instruction type and pictures (i.e., non-training version of the task)

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

This study will evaluate the effectiveness of approach-avoidance training (AATP) in a virtual reality (VR) bar environment compared to traditional AATP methods, involving 204 patients with alcohol use disorder across multiple countries.

The research aims to determine if the VR-enhanced AATP leads to better outcomes in reducing drinking, craving, and impulsiveness compared to standard treatment alone, potentially making AATP more effective in real-life drinking situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a virtual reality based, approach-avoidance training program for alcohol use disorder: a study protocol. Mellentin, AI., Nielsen, AS., Ascone, L., et al.[2021]

Patients treated with aversion therapy for alcoholism had significantly higher abstinence rates from alcohol at both 6 and 12 months compared to those who did not receive aversion therapy, indicating its efficacy in long-term alcohol cessation.

While the aversion therapy group also showed higher abstinence rates from all mood-altering substances at 6 months, this effect was not sustained at 12 months, suggesting that the benefits of aversion therapy may diminish over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six- and twelve-month abstinence rates in inpatient alcoholics treated with either faradic aversion or chemical aversion compared with matched inpatients from a treatment registry. Smith, JW., Frawley, PJ., Polissar, NL.[2008]

In a study of 81 individuals undergoing treatment for alcohol dependence, both approach and avoidance inclinations towards alcohol were found to significantly relate to problem recognition and treatment engagement, with avoidance inclinations linked to attending more therapy sessions.

Changes in drinking behavior were associated with changes in approach inclinations, suggesting that fostering a desire to approach positive behaviors may lead to better treatment outcomes, while avoidance inclinations were more related to initial treatment engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between approach and avoidance inclinations to use alcohol and treatment outcomes. Schlauch, RC., Stasiewicz, PR., Bradizza, CM., et al.[2021]

In a study of 200 patients treated for alcoholism using a multimodal program that included aversion therapy, the abstinence rate was 71.3% during the first 12 months and 65% over an average follow-up of 20.5 months.

The current abstinence rate, defined as no alcohol use in the last 6 months, was notably high at 78.1%, indicating that aversion therapy can be an effective component of alcoholism treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term abstinence from alcohol in patients receiving aversion therapy as part of a multimodal inpatient program. Smith, JW., Frawley, PJ.[2019]

Controlled drinking training, based on avoidance conditioning, can be an effective alternative to complete abstinence for some individuals struggling with alcohol use, as demonstrated in a case study of a 33-year-old female.

The treatment allowed the participant to engage in sexual intercourse without the need for alcohol, indicating a potential improvement in her quality of life and ability to manage drinking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled drinking training with a female alcoholic. Brown, RA.[2019]

A novel nicotine Approach-Avoidance-Task (AAT) training significantly modified the automatic approach bias towards nicotine-related cues in smokers, suggesting it can influence addictive behaviors.

The AAT training led to a greater reduction in nicotine consumption at a three-month follow-up compared to a sham training, indicating its potential as an effective long-term intervention for reducing smoking in psychiatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approach bias modification in inpatient psychiatric smokers. Machulska, A., Zlomuzica, A., Rinck, M., et al.[2017]

A study involving 80 participants demonstrated that both typical and novel versions of approach-avoidance training (AAT) can effectively change negative evaluations of fear-conditioned stimuli, such as a dead cat.

Despite testing a new version of AAT, there was no evidence that it was more effective than the traditional method, suggesting that both approaches can help alter fear responses, although the sample size may limit the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does approaching puppies and avoiding a dead cat improve the effectiveness of approach-avoidance training for changing the evaluation of feared stimuli? Mertens, G., Van Dessel, P., Engelhard, IM.[2021]

The study aims to evaluate the feasibility and acceptability of 'SWIPE,' a personalized and gamified smartphone app designed to help individuals with hazardous drinking habits reduce their alcohol consumption through approach bias modification (ABM).

By recruiting 500 participants who wish to reduce their drinking, the study will assess changes in alcohol consumption and cravings over four weeks, potentially providing a convenient and accessible intervention for those who may not seek traditional treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Approach Bias Modification Smartphone App ("SWIPE") to Reduce Alcohol Use Among People Drinking at Hazardous or Harmful Levels: Protocol for an Open-Label Feasibility Study. Manning, V., Piercy, H., Garfield, JBB., et al.[2020]

Detoxification is often the first step in alcoholism treatment for over 700,000 people in the U.S. daily, and it can be combined with behavioral therapies like cognitive-behavioral therapy and Alcoholics Anonymous.

A major clinical study, Project MATCH, found no significant differences in outcomes among various behavioral treatment approaches, suggesting that the choice of therapy may depend more on individual patient characteristics rather than the type of therapy itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcoholism treatment in the United States. An overview. Fuller, RK., Hiller-Sturmhöfel, S.[2023]

A pilot study involving 1082 participants using a mobile app for alcohol avoidance training showed a significant reduction in alcohol consumption, with an average decrease of 7.8 units per week after 3 weeks and an additional reduction of 6.2 units at 3 months.

The app was well-received, with 79% of participants completing the recommended sessions and positive feedback on its user-friendly design, indicating that mobile cognitive bias modification could be a promising tool for helping individuals reduce alcohol use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol Avoidance Training as a Mobile App for Problem Drinkers: Longitudinal Feasibility Study. Laurens, MC., Pieterse, ME., Brusse-Keizer, M., et al.[2021]

References

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

A randomized controlled trial of a virtual reality based, approach-avoidance training program for alcohol use disorder: a study protocol. [2021]

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

Approach avoidance training versus Sham in veterans with alcohol use disorder: protocol for a randomized controlled trial. [2023]

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

Six- and twelve-month abstinence rates in inpatient alcoholics treated with either faradic aversion or chemical aversion compared with matched inpatients from a treatment registry. [2008]

4. England pubmed.ncbi.nlm.nih.gov

Relationship between approach and avoidance inclinations to use alcohol and treatment outcomes. [2021]

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

Long-term abstinence from alcohol in patients receiving aversion therapy as part of a multimodal inpatient program. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Controlled drinking training with a female alcoholic. [2019]

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

Approach bias modification in inpatient psychiatric smokers. [2017]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Does approaching puppies and avoiding a dead cat improve the effectiveness of approach-avoidance training for changing the evaluation of feared stimuli? [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

Personalized Approach Bias Modification Smartphone App ("SWIPE") to Reduce Alcohol Use Among People Drinking at Hazardous or Harmful Levels: Protocol for an Open-Label Feasibility Study. [2020]

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

Alcoholism treatment in the United States. An overview. [2023]

11. Canada pubmed.ncbi.nlm.nih.gov

Alcohol Avoidance Training as a Mobile App for Problem Drinkers: Longitudinal Feasibility Study. [2021]