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

Trial Summary

What is the purpose of this trial?

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 alcohol use problems and 2) feasibility of research protocols with emerging adults (18-29 year-olds) who present to the emergency department.

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 data supports the effectiveness of the Avatar-Guided Intervention treatment for alcohol use and suicidal thoughts?

Research shows that interventions like Dialectical Behavior Therapy (DBT) skills training, which can be delivered online, have been effective in reducing suicidal thoughts and heavy drinking. This suggests that similar approaches, like the Avatar-Guided Intervention, might also help people struggling with alcohol use and suicidal thoughts. ^{1 2 3 4 5}

How is the EA-Avatar treatment for alcohol use and suicidal thoughts different from other treatments?

The EA-Avatar treatment is unique because it uses a digital avatar to facilitate a dialogue between the patient and a representation of their issues, which can help reduce hostility and empower the patient, unlike traditional face-to-face therapy. ^{6 7 8 9 10}

Research Team

Lourah M. Kelly

Principal Investigator

UMass Worcester (UMass Chan Medical School)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of an Internet delivered dialectical behavior therapy skills training for suicidal and heavy episodic drinkers. [2022]

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

Preventing addiction related suicide: a pilot study. [2022]

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

Evaluation of a suicide prevention training curriculum for substance abuse treatment providers based on Treatment Improvement Protocol Number 50. [2022]

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

Cognitive behavioral therapy for suicide prevention among Veterans receiving substance use disorder treatment: Results from a randomized trial. [2023]

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

Treatment of co-occurring substance abuse and suicidality among adolescents: a randomized trial. [2022]

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

AVATAR Therapy for Distressing Voices: A Comprehensive Account of Therapeutic Targets. [2023]

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

Innovations in Practice: Avatar-based virtual reality in CAMHS talking therapy: two exploratory case studies. [2020]

8. England pubmed.ncbi.nlm.nih.gov

AVATAR therapy for auditory verbal hallucinations in people with psychosis: a single-blind, randomised controlled trial. [2019]

9. England 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. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Avatar Intervention for Cannabis Use Disorder in Individuals with Severe Mental Disorders: A Pilot Study. [2023]