Avatar-Guided Intervention for Alcohol Use and Suicidal Thoughts

(EA-Avatar Trial)

Recruiting at 1 trial location

Overseen By Lourah M Kelly, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Severe cognitive delay, active psychosis, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile app, EA-Avatar, designed to help manage alcohol use and suicidal thoughts. The app uses an avatar to guide users in tracking their drinking habits and recognizing triggers for harmful thoughts, offering coping skills and support resources. It also sends encouraging text reminders to keep users engaged. Individuals who have recently experienced binge drinking and suicidal thoughts might be suitable participants if they own a smartphone and understand English. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could benefit many others in the future.

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 healthcare provider.

What prior data suggests that this mobile health intervention is safe for emerging adults?

Research shows that the EA-Avatar treatment is a mobile health tool designed to help manage alcohol use and suicidal thoughts. It uses an avatar to guide users and provide education and practice skills.

This trial focuses on the tool's usability, so specific safety data from earlier studies is not available. However, as a digital tool, it is generally considered low-risk. Unlike traditional medications, digital tools don't cause side effects like nausea or headaches.

Other studies have shown that similar mobile health tools are well-received. They are often seen as safe because they don't involve taking drugs or undergoing medical procedures. With any new tool or treatment, it’s important to ask questions and understand its purpose and function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike typical treatments for alcohol use and suicidal thoughts that often involve therapy or medication, EA-Avatar leverages a digital, avatar-guided intervention. This unique approach provides users with interactive, personalized support that monitors alcohol use and triggers for suicidal thoughts, offering strategies to manage them. Additionally, it sends text reminders to engage with the platform, providing encouragement and resources for further care. Researchers are excited because this method not only offers immediate, accessible support alongside traditional emergency care but also engages users in a novel, tech-driven way that might improve outcomes and adherence.

What evidence suggests that the EA-Avatar intervention is effective for managing alcohol use and suicidal thoughts?

Research has shown that avatar-guided programs can help manage alcohol use and suicidal thoughts. In past studies, these digital tools helped young adults reduce drinking and address suicidal thoughts. In this trial, participants will receive the EA-Avatar program, which uses an avatar to guide users through skills and resources to manage these issues. Early results suggest the program effectively engages people, offering timely reminders and support through text messages. It is designed to work alongside regular emergency care, providing extra help for those in need. ^{2 3 4 5 6}

Who Is on the Research Team?

Lourah M. Kelly

Principal Investigator

UMass Worcester (UMass Chan Medical School)

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-29 who visit the emergency department and struggle with heavy drinking and thoughts of suicide. The details on specific inclusion or exclusion criteria are not provided, but typically these would outline health conditions, behaviors, or medications that qualify or disqualify someone from participating.

Inclusion Criteria

Emergency department admission for alcohol- or suicide-related reason

Speak, read, and understand English

Owning and having access to a personal smartphone

Exclusion Criteria

Severe cognitive delay, active psychosis, or heavy intoxication that precludes research participation

At imminent safety risk and need to be on a 1:1 observation, in which case research may interfere with their clinical care in the emergency department

Under arrest or a prisoner/inmate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants receive the avatar-guided digital intervention and text message intervention (EA-Avatar) for 12 weeks in addition to usual emergency department care

12 weeks

Daily assessments and four follow-ups at 4-, 8-, and 12-weeks after discharge

Follow-up

Participants are monitored for usability and feasibility of the intervention through follow-up assessments

12 weeks

4 follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• EA-Avatar

Trial Overview The study is testing a new mobile health intervention called EA-Avatar designed to help manage suicidal thoughts and excessive alcohol use in emerging adults. It's an initial test to see if the app is user-friendly and whether the research methods work well in this age group.

How Is the Trial Designed?

Group I: EA-Avatar Experimental Treatment 1 Intervention

The avatar-guided digital intervention includes monitoring of alcohol use and common triggers suicidal thoughts, skills to manage alcohol use and suicidal thoughts, resources on how to access outpatient care and crisis hotlines for suicidal thoughts, and achievements for milestones. In addition, text messages provide reminders to access the avatar platform to learn or practice skills and provide encouragement. EA-Avatar is given in addition to emergency department care as usual.

EA-Avatar is already approved in United States for the following indications:

Approved in United States as EA-Avatar for:

• Alcohol use disorder
• Suicidal ideation

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

AVATAR therapy is an innovative treatment that allows individuals to engage in face-to-face dialogue with a digital avatar representing their distressing voices, showing promise in addressing these experiences.

This article provides a comprehensive overview of the therapy's delivery, therapeutic targets, acceptability, and potential side effects, highlighting its growing interest and importance for future research and development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AVATAR Therapy for Distressing Voices: A Comprehensive Account of Therapeutic Targets. Ward, T., Rus-Calafell, M., Ramadhan, Z., et al.[2023]

A pilot randomized controlled trial with 59 participants indicated that Internet-delivered Dialectical Behavior Therapy skills training (iDBT-ST) significantly reduced suicide ideation, alcohol use, and emotion dysregulation over four months.

Participants who received iDBT-ST immediately experienced faster reductions in alcohol consumption compared to those in the waitlist control group, suggesting that this online intervention could be an effective resource for individuals at high risk for suicide and alcohol misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of an Internet delivered dialectical behavior therapy skills training for suicidal and heavy episodic drinkers. Wilks, CR., Lungu, A., Ang, SY., et al.[2022]

The Preventing Addiction Related Suicide (PARS) module significantly improved knowledge and attitudes towards suicide prevention among 78 patients with substance addiction, with results showing strong statistical significance immediately after treatment and at a 1-month follow-up.

Participants also demonstrated increased positive help-seeking behaviors for suicidal issues concerning themselves and their friends and family, indicating that the PARS module effectively encourages proactive support strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing addiction related suicide: a pilot study. Voss, WD., Kaufman, E., O'Connor, SS., et al.[2022]

AVATAR therapy significantly reduced the severity of persistent auditory verbal hallucinations compared to supportive counselling, with a mean difference in scores indicating a large effect size after 12 weeks of treatment in a study involving 150 participants.

No adverse events were reported for either AVATAR therapy or supportive counselling, suggesting that AVATAR therapy is a safe intervention for individuals experiencing these hallucinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AVATAR therapy for auditory verbal hallucinations in people with psychosis: a single-blind, randomised controlled trial. Craig, TK., Rus-Calafell, M., Ward, T., et al.[2019]

Avatar-assisted therapy (AAT) is a promising new method for substance abuse treatment, allowing remote participation in group counseling, which may help individuals who struggle to access traditional treatment.

In a pilot study of 59 participants, those who completed 16 weeks of AAT attended significantly more sessions and had lower rates of positive urine drug screens, suggesting that AAT could improve treatment retention and success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avatar-assisted therapy: a proof-of-concept pilot study of a novel technology-based intervention to treat substance use disorders. Gordon, MS., Carswell, SB., Schadegg, M., et al.[2018]

A 2-hour suicide prevention training for 273 substance use disorder (SUD) treatment providers significantly improved their self-efficacy, knowledge, and practice behaviors related to suicide prevention, with results showing statistical significance (p < .001).

The training, which utilized a video based on a recognized protocol from the Substance Abuse and Mental Health Services Administration, demonstrated high potential for widespread adoption due to its brief duration and ease of implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a suicide prevention training curriculum for substance abuse treatment providers based on Treatment Improvement Protocol Number 50. Conner, KR., Wood, J., Pisani, AR., et al.[2022]

A pilot clinical trial involving 19 participants with cannabis use disorder and severe mental disorder showed that an innovative avatar intervention led to a significant moderate reduction in cannabis use, with a Cohen's d of 0.611, indicating effectiveness.

The intervention utilized immersive virtual reality techniques, allowing participants to practice therapeutic methods in real-time, suggesting that this novel approach could enhance treatment outcomes for cannabis use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Avatar Intervention for Cannabis Use Disorder in Individuals with Severe Mental Disorders: A Pilot Study. Giguère, S., Potvin, S., Beaudoin, M., et al.[2023]

The integrated cognitive-behavioral treatment (I-CBT) for adolescents with co-occurring alcohol or other drug use disorders and suicidality led to significantly fewer heavy drinking days and days of marijuana use compared to enhanced treatment as usual (E-TAU).

I-CBT also resulted in lower rates of suicide attempts, psychiatric hospitalizations, emergency department visits, and arrests, indicating its effectiveness in improving both substance use and suicidal behavior among adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of co-occurring substance abuse and suicidality among adolescents: a randomized trial. Esposito-Smythers, C., Spirito, A., Kahler, CW., et al.[2022]

Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP) was tested in a study with 299 Veterans undergoing substance use disorder treatment, aiming to reduce suicidal ideation and behaviors, but did not show significant superiority over a control group (Supportive Psychoeducational Control) in primary outcomes.

While the frequency of suicidal thoughts remained stable over 24 months, CBT-SP participants exhibited fewer preparatory behaviors for suicide compared to the control group, suggesting some benefit in reducing specific risk factors, even though overall outcomes were similar.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for suicide prevention among Veterans receiving substance use disorder treatment: Results from a randomized trial. Ilgen, MA., Olson-Madden, JH., Price, A., et al.[2023]

Avatar-based virtual reality therapy, specifically using the ProReal software, has shown promise in helping young people engage in therapy, with outcome measures indicating a reduction in mental health difficulties over time.

The two case studies highlighted that ProReal was accessible and effective in helping young users externalize their thoughts and feelings, facilitating better communication with their clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovations in Practice: Avatar-based virtual reality in CAMHS talking therapy: two exploratory case studies. Falconer, CJ., Davies, EB., Grist, R., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-binge-drinking-8-2024-9ceb2

Avatar-Guided Intervention for Alcohol Use and Suicidal Thoughts This study is an open pilot usability trial to test the 1) usability of a newly developed mobile health intervention to help manage suicidal ideation and ...

2. umassmed.edu umassmed.edu/TransitionsACR/research/projects-by-grant/development-and-evaluation-of-an-avatar-guided-mobile-health-for-emerging-adults/

Development and Evaluation of an Avatar Guided Mobile ... This project pilots refines, and evaluates a novel mobile health intervention guided by an avatar for emerging adults who binge drink and experience thoughts ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06595862/open-pilot-trial-evaluating-an-avatar-guided-intervention-for-emerging-adults-with-alcohol-use-problems-and-suicide-risk

Open Pilot Trial Evaluating an Avatar-Guided Intervention ... The main study aims are to test the usability of a newly developed avatar-guided mobile health intervention and feasibility of 28 days of daily ...

4. reporter.nih.gov reporter.nih.gov/project-details/8867969

A Text-Message Intervention to Reduce Alcohol Use ... This proposal seeks to improve identification of at-risk young adults by screening them in the ED, improve engagement by using a mobile communication (text ...

5. ctclearinghouse.org ctclearinghouse.org/Customer-Content/www/files/PDFs/L_Kelly_-_Avatar_Digital_Intervention_for_Drinking_and_Suicide_Risk_2023.pdf

emerging adults with alcohol misuse and suicidal thoughts CURRENT STUDY • The purpose of this study is to design an avatar- guided mHealth intervention to reduce alcohol misuse and suicidal thoughts in emerging adults ...

6. reporter.nih.gov reporter.nih.gov/project-details/11145118

RePORT RePORTER - National Institutes of Health (NIH) | This study seeks to design an evidence-informed interactive, avatar-guided mHealth intervention to provide ongoing education, skills practice, mood and behavior ...