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

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT01958359
Collaborator
(none)
260
1
3
36.9
7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Short IVR
  • Behavioral: Therapeutic IVR
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
260 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Screening and Brief Intervention Via IVR for Problematic Use of Alcohol: A Randomized Controlled Trial
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Mar 1, 2014
Actual Study Completion Date :
Mar 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Short IVR

IVR-based alcohol diary with feedback

Behavioral: Short IVR
IVR-based alcohol diary with feedback

Experimental: Therapeutic IVR

IVR-based conversation offering a menu of exercises and vignettes.

Behavioral: Therapeutic IVR
IVR-based conversation offering a menu of exercises and vignettes.

No Intervention: Control

Untreated control group

Outcome Measures

Primary Outcome Measures

  1. 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

  1. User satisfaction [6 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • AUDIT >7 for men or AUDIT >5 for women.
Exclusion Criteria:
  • AUDIT <8 (men) or <6 (women)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karolinska institutet, Department of Clinical Neuroscience Stockholm Sweden 17176

Sponsors and Collaborators

  • Karolinska Institutet

Investigators

  • Principal Investigator: Anne H Berman, PhD, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Anne H Berman, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01958359
Other Study ID Numbers:
  • 2010/1437-31/4
First Posted:
Oct 9, 2013
Last Update Posted:
Nov 4, 2014
Last Verified:
Nov 1, 2014

Study Results

No Results Posted as of Nov 4, 2014