Clinical trial NCT01958359: Screening and Brief Intervention Via IVR for Problematic Use of Alcohol: A Randomized Controlled Trial
Official title: Screening and Brief Intervention Via IVR for Problematic Use of Alcohol: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Problem Drinking
Keywords: Randomized Controlled Trial
Alcohol
Telephone
Mobile phone
Screening
Brief intervention
IVR-based conversation menu with exercises and vignettes
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* AUDIT \<8 (men) or \<6 (women)

Primary outcomes:
measure: AUDIT
timeFrame: 6 months
Secondary outcomes:
measure: User satisfaction
timeFrame: 6 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska institutet, Department of Clinical Neuroscience
Study officials:
affiliation: Karolinska Institutet
name: Anne H Berman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.