Electronic Harm Reduction Treatment for Alcohol

Phase 3

Not yet recruiting

• Conditions: Alcohol Use Disorder; Harm Reduction; Housing First (eg. Permanent Supportive Housing)

• Registration Number: NCT06702007
• Lead Sponsor: University of Washington

Brief Summary

The goal of this project is to transform a successful, face-to-face harm-reduction treatment (HaRT-A) into a digital format, creating eHaRT-A. This new platform is specifically designed for people who have experienced homelessness and an alcohol use disorder (AUD), living within the framework of permanent, supportive, Housing First (HF) facilities. We hypothesize eHaRT-A will be more effective than the standard HF services in reducing alcohol-related harm and improving the overall quality of life for participants.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Study Start: 2025-01-01
• Primary Completion: 2027-01
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Being at least 21 years of age
• Speak English fluently
• Currently a registered client at one of the Housing First sites
• Currently drinking (has used alcohol in the past 2 weeks)
• Meeting criteria for "current" (e.g., past-year) AUD according to the Diagnostic and Statistical Manual of Mental Health Disorders, Fifth Edition (determined as scoring >= 2 on the SCID-5-CV)

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Exclusion Criteria

• Enrollment in any related treatment studies (including studies by this research team)
• Refusal or inability to consent
• Constituting a risk to the safety and security of residents or staff

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in physical and mental-health related quality of life from baseline through 3-month follow-up as measured by the EQ-5D-5L	Baseline through 3-month follow-up	The EQ-5D-5L is a psychometrically sound, 5-item, 5-point Likert scale measure that comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Its summary score will reflect participants' health-related quality of life (HRQoL) as a primary outcome.
Change in typical and peak alcohol quantity consumed from baseline through 3-month follow-up as assessed by the AQUA.	Baseline through 3-month follow-up	The Alcohol Quantity and Use Assessment (AQUA) was created by the research team for previous studies with a similar population and will be used to record the quantity of alcohol consumed on participants' heaviest and typical drinking days in the past two weeks. Scores are expressed in number of standard drinks with higher numbers indicating heavier drinking.
Change in alcohol-related harm from baseline through 3-month follow-up as assessed by the SIP-2R.	Baseline to 3-month follow-up	The Short Inventory of Problems (SIP-2R) is a 15-item, Likert-scale questionnaire that measures social, occupational and psychological alcohol-related problems. The summary score will serve as the alcohol-related problems outcome measure.
Feasibility of eHaRT-A within Housing First	Baseline to 3-month follow-up.	Feasibility will be assessed as ease of enrollment of participants into the study as well as ability to retain participants during the intervention portion of the study (i.e., percentage screened who expressed interest, qualified, and completed eHaRT-A).

Secondary Outcome Measures

Name	Time	Method
Change in motivation/readiness/importance/confidence to engage in harm reduction from baseline through 3-month follow-up as assessed by the MTC.	Baseline through 3-month follow-up	MTC rulers will be measured using three, 10-point "readiness rulers" (Center for Substance Abuse Treatment, 1999), which assess participants' readiness for, confidence about, and perception of the importance of changing drinking behavior to reduce its "negative side effects," where 0 = not at all ready/confident/important and 10 = totally ready/confident/ important. Readiness rulers have been shown to be associated with alcohol outcomes and have evinced adequate psychometric properties (Bertholet, Gaume, Faouzi, Daeppen, \& Gmel, 2012; Heather, Smailes, \& Cassidy, 2008; LaBrie, Shiffman, \& Earleywine, 2005; Maisto et al., 2011).
Change in alcohol frequency from baseline through 3-month follow-up as assessed by the ASI.	Baseline through 3-month follow-up	The Alcohol and Substance-use Frequency Assessment questions were adapted from the Addiction Severity Index and will be used to assess frequency of use of alcohol and other substances as well as route of administration.
Change in biochemical verification of EtG from baseline to 3-month follow-up.	Baseline to 3-month follow-up	Presence of EtG, a direct metabolite of alcohol (cut-off \> 500 ng/ml), which is indicative of heavy alcohol use within the past 3 days, will be used as a primary outcome.