Electronic Harm Reduction Treatment for Alcohol

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Washington

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • eHaRT-A

    Behavioral

    Adaptation of the Harm Reduction Treatment for Alcohol (HaRT-A) into a digital telehealth platform facilitating harm reduction treatment via patient-provider video sessions (eHaRT-A). eHaRT-A will include the three treatment components from the efficacious HaRT-A. eHaRT-A will be delivered during one-on-one sessions through video conferencing with interactive features (i.e., personalized feedback tracked over time and screen sharing).

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Housing First As UsualNo intervention 0 interventions
Group B: Housing First + eHaRT-AExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Baseline through 3-month follow-up
2

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

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.

Time frame
Baseline through 3-month follow-up
3

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

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.

Time frame
Baseline to 3-month follow-up
4

Feasibility of eHaRT-A within Housing First

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).

Time frame
Baseline to 3-month follow-up.

Secondary outcomes

1

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

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).

Time frame
Baseline through 3-month follow-up
2

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

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.

Time frame
Baseline through 3-month follow-up
3

Change in biochemical verification of EtG from 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.

Time frame
Baseline to 3-month follow-up

Other outcomes

1

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

The Safer-drinking and Harm Reduction Efforts (SHaRE) form is an open-ended grid created for use in the harm reduction treatment (HaRT-A) to elicit participant-stated goals and safer-drinking tips. The SHaRE will be administered during the initial eHaRT-A sessions and at the follow-up sessions to record participants' current harm reduction goals and to measure whether participants achieved (yes/no) or made measurable progress (yes/no) towards their previously set harm reduction goals according to participants' and interventionists' assessments. The self-reported use of safer drinking strategies will be discussed and monitored during eHaRT-A sessions using the safer drinking portion of the open-ended SHaRE. Reported use of achievement of goals and safer drinking strategies across the course of the study will be used as an outcome in treatment receipt and enactment analyses.

Time frame
Baseline through 1-month follow-up.
2

Change in pain from baseline through 3-month as assessed by the BPI.

BPI-SF: Self-report questionnaire (Cleeland; Mendoza, Mayne, Rublee, \& Cleeland, 2006), used to assess the severity of pain and the impact of pain on daily functions. There are 9 items asking participants to rate their worst, least, average, and current pain intensity. They are also asked to list current pain-treatments and their perceived effectiveness. They are given a list of current treatments and their perceived effectiveness, and asked to rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10-point scale.

Time frame
Baseline through 3-month follow-up
3

eHaRT-A participant feedback at follow-up.

The Feedback Form will ascertain participants' feedback regarding the eHaRT-A in the form of semi-structured qualitative prompts. This measure will be delivered at the final treatment appointment or the 3-month follow-up if they don't complete the final treatment appointment.

Time frame
1- or 3- month follow-up.
4

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

Anticipated Impact and Acceptability Rulers are 5 single, 10-point, items based on an established measure, assessing participants' expectations for how acceptable, effective, helpful, and hopeful they perceive eHaRT-A activities to be for themselves and others.

Time frame
Baseline through 3-month follow-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator