Behavioral Intervention

eHaRT-A for Alcoholism (eHaRT-A Trial)

Seattle, WA

Phase 3

Recruiting

Led By Tessa Frohe, PhD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Being at least 21 years of age

Be older than 18 years old

Must not have

Refusal or inability to consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1- or 3- month follow-up.

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial aims to convert a successful in-person alcohol harm-reduction treatment into a digital version called eHaRT-A. The study will focus on individuals who have faced homelessness and have an alcohol use disorder

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Who is the study for?

This trial is for English-speaking adults over 21 who are registered at Housing First sites, currently drink alcohol, and meet the criteria for an Alcohol Use Disorder (AUD) as per the Diagnostic and Statistical Manual of Mental Health Disorders.Check my eligibility

What is being tested?

The study is testing eHaRT-A, a digital version of a face-to-face harm-reduction treatment designed for people with AUD who have experienced homelessness. It aims to see if it's more effective than standard services in reducing alcohol-related harm.See study design

What are the potential side effects?

Since eHaRT-A is a digital platform rather than a medication or medical procedure, traditional side effects are not applicable. However, participants may experience emotional or psychological discomfort while engaging with the content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or older.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot or do not want to give consent for treatment.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1- or 3- month follow-up.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1- or 3- month follow-up.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1- or 3- month follow-up. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in alcohol-related harm from baseline through 3-month follow-up as assessed by the SIP-2R.

Change in physical and mental-health related quality of life from baseline through 3-month follow-up as measured by the EQ-5D-5L

Change in typical and peak alcohol quantity consumed from baseline through 3-month follow-up as assessed by the AQUA.

+1 more

Secondary study objectives

Change in alcohol frequency from baseline through 3-month follow-up as assessed by the ASI.

Change in biochemical verification of EtG from baseline to 3-month follow-up.

Change in motivation/readiness/importance/confidence to engage in harm reduction from baseline through 3-month follow-up as assessed by the MTC.

Other study objectives

Acceptability of the eHaRT-A intervention as assessed by the AIM at posttest.

Change in acceptability, effectiveness, and likelihood to engage in eHaRT-A activities as assessed by Acceptability Rulers.

Change in eHaRT receipt/enactment outcomes from baseline to 1-month follow-up as assessed by the SHaRE form.

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Housing First + eHaRT-AExperimental Treatment1 Intervention

HaRT-A comprises three concrete treatment components: 1) measurement and participant-led tracking of indicators of alcohol-related harm (e.g., number of drinks, blackouts), 2) elicitation of harm-reduction and health related quality of life (HRQoL) goals (e.g., drink slower, eat healthier, reconnect with family), and 3) discussion of safer-drinking strategies (e.g., taking B-complex vitamins, eating prior to or during alcohol use, avoiding mixing alcohol and other drugs). HaRT-A honors community representation within harm-reduction intervention development and acknowledges the larger forces (familial, community, geopolitical) at play in substance use, thus emphasizing the wisdom of the participant in defining their own pathway to recovery.

Group II: Housing First As UsualActive Control1 Intervention

Housing First as usual includes housing provision and management, fulfillment of basic needs (e.g., food, clothing), nursing/medical services and case management.

0 / 2Eligibility criteria met