Ignite Creation Date:
2024-05-06 @ 2:02 AM
Last Modification Date:
2024-10-26 @ 11:13 AM
Study NCT ID:
NCT01958359
Status:
COMPLETED
Last Update Posted:
2014-11-04
First Post:
2013-10-06
Brief Title:
Screening and Brief Intervention Via IVR for Problematic Use of Alcohol A Randomized Controlled Trial
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Screening and Brief Intervention Via IVR for Problematic Use of Alcohol A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 247 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None