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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

Effects of automated smartphone mobile recovery support and telephone continuing care in the treatment of alcohol use disorder: study protocol for a randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
James R. McKay, David H. Gustafson, Megan Ivey, Fiona McTavish, Klaren Pe-Romashko, Brenda Curtis, David A. Oslin, Daniel Polsky, Andrew Quanbeck, Kevin G. Lynch
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2466-1) contains supplementary material, which is available to authorized users.

Abstract

Background

New smartphone communication technology provides a novel way to provide personalized continuing care support following alcohol treatment. One such system is the Addiction version of the Comprehensive Health Enhancement Support System (A-CHESS), which provides a range of automated functions that support patients. A-CHESS improved drinking outcomes over standard continuing care when provided to patients leaving inpatient treatment. Effective continuing care can also be delivered via telephone calls with a counselor. Telephone Monitoring and Counseling (TMC) has demonstrated efficacy in two randomized trials with alcohol-dependent patients. A-CHESS and TMC have complementary strengths. A-CHESS provides automated 24/7 recovery support services and frequent assessment of symptoms and status, but does not involve regular contact with a counselor. TMC provides regular and sustained contact with the same counselor, but no ongoing support between calls. The future of continuing care for alcohol use disorders is likely to involve automated mobile technology and counselor contact, but little is known about how best to integrate these services.

Methods/Design

To address this question, the study will feature a 2 × 2 design (A-CHESS for 12 months [yes/no] × TMC for 12 months [yes/no]), in which 280 alcohol-dependent patients in intensive outpatient programs (IOPs) will be randomized to one of the four conditions and followed for 18 months. We will determine whether adding TMC to A-CHESS produces fewer heavy drinking days than TMC or A-CHESS alone and test for TMC and A-CHESS main effects. We will determine the costs of each of the four conditions and the incremental cost-effectiveness of the three active conditions. Analyses will also examine secondary outcomes, including a biological measure of alcohol use, and hypothesized moderation and mediation effects.

Discussion

The results of the study will yield important information on improving patient alcohol use outcomes by integrating mobile automated recovery support and counselor contact.

Trial registration

ClinicalTrials.gov, NCT02681406. Registered on 2 September 2016.
Zusatzmaterial
Additional file 1: SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*. (DOC 122 kb)
13063_2018_2466_MOESM1_ESM.doc
Literatur
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