Smartphone Based Continuing Care for Alcohol

NCT02681406 | Completed Results

• 1 other identifier: 819881
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators will recruit 280 alcohol dependent patients in treatment programs in the Philadelphia area to test the efficacy and cost efficiency of a smartphone based application for treating alcohol addiction (ACHESS) with telephone monitoring and counseling (TMAC). Participation in the study lasts for 18 months with research visits at baseline, 3 months, 6 months, 9 months, 12 months, and 18 months. The intervention lasts 12 months.

Conditions

Alcohol Abuse

Outcome Measures

Primary Outcomes (1)

• Time Line Follow Back, Percent Heavy Alcohol Use

  The primary outcome measure will be percent days of heavy alcohol use (i.e., \> 5 drinks/day for men, \> 4 drinks/day for women) within each follow-up period. Studies have consistently supported the reliability and validity of the TLFB with alcohol dependent individuals. Frequency of heavy alcohol use was selected because alcohol-related problems are correlated with the frequency of heavy drinking days. This outcome is also sensitive to reductions in problematic or high risk use, which are particularly important in a disease management model.

  18 month: months 13 - 18 post baseline

Study Arms (4)

Treatment as Usual

NO INTERVENTION

Participants randomized to this condition will continue their schedules and treatments as they had been and just come in to see research staff for research visits.

Telephone Monitoring and Counseling

EXPERIMENTAL

TMC - participants receive brief (20 minute) telephone counseling once weekly, then biweekly, etc for 12 months.

Behavioral: TMC

ACHESS

EXPERIMENTAL

Participants are signed up for an addiction based smart phone application that connects them in an anonymous fashion to a social network of other people in the study who are also struggling with alcohol addiction and sober living.

Behavioral: ACHESS

TMC + ACHESS

EXPERIMENTAL

Participants in this arm receive both interventions - the telephone counseling plus the ACHESS phone application.

Behavioral: ACHESS; Behavioral: TMC

Interventions

ACHESS BEHAVIORAL

Smartphone based additions focused application, encouraging social support

ACHESS; TMC + ACHESS

TMC BEHAVIORAL

Brief telephone monitoring and counseling

TMC + ACHESS; Telephone Monitoring and Counseling

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have a DSM-V diagnosis of current, moderate to severe alcohol use disorder
• have completed 3 weeks of IOP
• be 18-75 years of age
• be able to provide the name and verified telephone number of at least two contacts to help reach participants for follow up appointments
• functionally literate and have sufficient ability to read a smart phone
• be willing to be randomized as part of the clinical trial

You may not qualify if:

• have a current psychotic disorder or dementia severe enough to prevent participation in treatment
• have an acute medical problem requiring immediate inpatient treatment
• are participating in other forms of treatment for substance abuse, besides IOP
• are unable to read/comprehend for informed consent

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• McKay JR, Gustafson DH, Ivey M, Pe-Romashko K, Curtis B, Thomas T, Oslin DW, Polsky D, Quanbeck A, Lynch KG. Efficacy and comparative effectiveness of telephone and smartphone remote continuing care interventions for alcohol use disorder: a randomized controlled trial. Addiction. 2022 May;117(5):1326-1337. doi: 10.1111/add.15771. Epub 2021 Dec 23.

  PMID: 34859519 DERIVED

• McKay JR, Gustafson DH, Ivey M, McTavish F, Pe-Romashko K, Curtis B, Oslin DA, Polsky D, Quanbeck A, Lynch KG. 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. Trials. 2018 Jan 30;19(1):82. doi: 10.1186/s13063-018-2466-1.

  PMID: 29382367 DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: James McKay
• Organization: University of Pennsylvania

jimrache@upenn.edu

215-746-7704

Study Officials

• James R. McKay, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 12, 2016
• Study Start: September 1, 2014
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: March 9, 2022
• Results First Posted: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)