Screening and Brief Intervention Via IVR for Problematic Use of Alcohol: A Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Problem Drinking
• Interventions: Behavioral: Short IVR; Behavioral: Therapeutic IVR

• Registration Number: NCT01958359
• Lead Sponsor: Karolinska Institutet

Brief Summary

Objectives: The study evaluates the efficacy of two automated telephony, also known as, Interactive Voice Recognition (IVR) interventions, Short IVR and Therapeutic IVR. The Short IVR works as an interactive alcohol diary where the user is contacted once a week for four weeks to register their alcohol consumption during the preceding week. The user is given feedback on changes in alcohol consumption compared to last week. The Therapeutic IVR contacts the user once a week for four weeks and is also available for user-initiated calls 24/7 during this four-week period. The Therapeutic IVR allows the user to traverse a menu where the user chooses among listening to vignettes and doing exercises with the purpose of looking at alcohol consumption and exploring ways of coping with it.

Method: The design is a three-armed randomized controlled design, and outcomes are measured in terms of changes in problematic alcohol use at follow up six months after study initiation and baseline data gathering. Participants with problematic alcohol use (AUDIT \>7 for men and \>5 for women) are randomized into one of three groups: 1. Short IVR, 2. Therapeutic IVR and 3. Control group. Outcomes on alcohol use as well as information on the users' satisfaction with the intervention are assessed after 6 months.

The primary hypothesis for this study is that having access to one of the two IVR interventions will lead to a greater reduction of problematic alcohol use compared to controls who undergo only screening and follow-up assessment. The secondary hypothesis is that having access to either Short IVR or Therapeutic IVR leads to comparable reductions in risky drinking.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2013-10-06
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-09
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-02
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• AUDIT >7 for men or AUDIT >5 for women.

Exclusion Criteria

• AUDIT <8 (men) or <6 (women)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short IVR	Short IVR	IVR-based alcohol diary with feedback
Therapeutic IVR	Therapeutic IVR	IVR-based conversation offering a menu of exercises and vignettes.

Primary Outcome Measures

Name	Time	Method
AUDIT	6 months	Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).

Secondary Outcome Measures

Name	Time	Method
User satisfaction	6 months	Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).

Trial Locations

Locations (1)

Karolinska institutet, Department of Clinical Neuroscience; 🇸🇪 Stockholm, Sweden