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

Problem Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958359
• Other study ID #: 2010/1437-31/4
• Status: Completed
• Phase: N/A
• First received: October 6, 2013
• Last updated: November 2, 2014
• Start date: February 2011
• Est. completion date: March 2014

Study information

• Verified date: November 2014
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Swedish Data Inspection Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• AUDIT <8 (men) or <6 (women)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Problem Drinking

Intervention

Behavioral:
• Short IVR
IVR-based alcohol diary with feedback
• Therapeutic IVR
IVR-based conversation offering a menu of exercises and vignettes.

Locations

Country	Name	City	State
Sweden	Karolinska institutet, Department of Clinical Neuroscience	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUDIT	Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).	6 months	No
Secondary	User satisfaction	Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).	6 months	No

External Links

•   Anne H Berman's research group profile
•   Study information site.