Health Explorer - Optimizing Alcohol Brief Interventions

NCT01370226 | Completed

• 2 other identifiers: AA018659R01AA018659
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of the study are to develop and refine tailored motivational brief interventions that are parallel in structure but have varied delivery modalities (computer vs. therapist) for patients with at-risk or problematic alcohol use, and to conduct a randomized controlled trial comparing the efficacy of these BI approaches (CBI, TBI, control) on subsequent alcohol consumption and alcohol consequences, including alcohol-related injury, mental and physical-health functioning, and HIV risk behaviors at 3-, 6-, and 12-months post-ED visit.

Conditions

Alcohol Abuse

Outcome Measures

Primary Outcomes (6)

• Alcohol use - number of drinking days

  change over time (3, 6 and 12-months post baseline)

• Alcohol use - number of drinks per day

  change over time (3, 6 and 12-months post baseline)

• Alcohol use - number of binge drinking days

  change over time (3, 6 and 12-months post baseline)

• Alcohol use

  Alcohol Use Disorders Identification Test (AUDIT-C)

  change over time (3, 6 and 12-months post baseline)

• Alcohol related consequences

  Consequences are measured using the modified Short Inventory of Problems (SIP).

  change over time (3, 6 and 12-months post baseline)

• Alcohol related consequences

  Consequences are measured using the Drinker Inventory of Consequences (DrInC)

  change over time (3, 6 and 12-months post baseline)

Secondary Outcomes (4)

• Consequences of Alcohol Use - injury

  change over time (3, 6 and 12-months post baseline)

• Consequences of Alcohol Use - health functioning

  change over time (3, 6 and 12-months post baseline)

• Consequences of Alcohol Use - health functioning - depression

  change over time (3, 6 and 12-months post baseline)

• Consequences of Alcohol Use - HIV-risk behaviors

  change over time (3, 6 and 12-months post baseline)

Study Arms (3)

CBI

ACTIVE COMPARATOR

Computer delivered Brief Intervention

Behavioral: CBI

TBI

ACTIVE COMPARATOR

Therapist delivered Brief Intervention

Behavioral: TBI

EUC

NO INTERVENTION

Enhanced Usual Care

Interventions

CBI BEHAVIORAL

The multimedia, interactive Computer Brief Intervention (CBI) condition will be delivered using tablet computers. The content and format will be easily negotiated by participants. The 30-minute interventions are designed to address the primary target behavior of alcohol use, and will include a tailored review of participants' goals/values, feedback regarding their present alcohol use patterns and consequences (either actual experiences or potential based on risk behaviors), developing a discrepancy between their alcohol use and ability to meet goals and values through a decisional balance exercise, and formulation of a "change plan" tailored for each participant.

CBI

TBI BEHAVIORAL

Participants receive a 30-minute intervention session with a Master's-level clinician. The interventions are designed to address the primary target behavior of alcohol use, and will include a tailored review of participants' goals/values, feedback regarding their present alcohol use patterns and consequences (either actual experiences or potential based on risk behaviors), developing a discrepancy between their alcohol use and ability to meet goals and values through a decisional balance exercise, and formulation of a "change plan" tailored for each participant.

TBI

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ability to provide informed consent
• Additional criteria for intervention: past 3-month at-risk alcohol use

You may not qualify if:

• patients who do not understand English
• prisoners
• patients classified by medical staff as "Level 1 trauma" (e.g., unconscious, intubated on respirators, in need of immediate lifesaving procedures such as surgery)
• patients deemed unable to provide informed consent as stated above (e.g., intoxication, mental incompetence)
• patients treated in the ED for suicide attempts or sexual assault

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Michigan Health System Emergency Department

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Frederic C Blow, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 9, 2011
• Study Start: January 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 7, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)