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

NCT ID: NCT01958359

Last Updated: 2014-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-03-31

Brief Summary

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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

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Conditions

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Problem Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Short IVR

IVR-based alcohol diary with feedback

Group Type EXPERIMENTAL

Short IVR

Intervention Type BEHAVIORAL

IVR-based alcohol diary with feedback

Therapeutic IVR

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

Group Type EXPERIMENTAL

Therapeutic IVR

Intervention Type BEHAVIORAL

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

Control

Untreated control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Short IVR

IVR-based alcohol diary with feedback

Intervention Type BEHAVIORAL

Therapeutic IVR

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* AUDIT \>7 for men or AUDIT \>5 for women.

Exclusion Criteria

* AUDIT \<8 (men) or \<6 (women)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Anne H Berman

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne H Berman, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska institutet, Department of Clinical Neuroscience

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Andersson C, Gajecki M, Ojehagen A, Berman AH. Automated telephone interventions for problematic alcohol use in clinical and population samples: a randomized controlled trial. BMC Res Notes. 2017 Nov 28;10(1):624. doi: 10.1186/s13104-017-2955-4.

Reference Type DERIVED
PMID: 29183357 (View on PubMed)

Related Links

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http://www.telecoach.eu

Study information site.

Other Identifiers

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2010/1437-31/4

Identifier Type: -

Identifier Source: org_study_id

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