NCT01958359

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

November 4, 2014

Status Verified

November 1, 2014

Enrollment Period

3.1 years

First QC Date

October 6, 2013

Last Update Submit

November 2, 2014

Conditions

Problem Drinking

Keywords

Randomized Controlled TrialAlcoholTelephoneMobile phoneScreeningBrief interventionIVR-based conversation menu with exercises and vignettes

Outcome Measures

Primary Outcomes (1)

  • AUDIT

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

    6 months

Secondary Outcomes (1)

  • User satisfaction

    6 months

Study Arms (3)

Short IVR

EXPERIMENTAL

IVR-based alcohol diary with feedback

Behavioral: Short IVR

Therapeutic IVR

EXPERIMENTAL

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

Behavioral: Therapeutic IVR

Control

NO INTERVENTION

Untreated control group

Interventions

Short IVRBEHAVIORAL

IVR-based alcohol diary with feedback

Short IVR
Therapeutic IVRBEHAVIORAL

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

Therapeutic IVR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • AUDIT \<8 (men) or \<6 (women)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska institutet, Department of Clinical Neuroscience

Stockholm, 17176, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 29183357DERIVED

Related Links

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Anne H Berman, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 6, 2013

First Posted

October 9, 2013

Study Start

February 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

November 4, 2014

Record last verified: 2014-11

Locations

SE(1)