Impact of Enhancements to Smartphone Based Continuing Care for Alcohol Dependence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 262
- Locations
- 2
- Primary Endpoint
- Time Line Follow Back, Percent Heavy Alcohol Use
Study Overview
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.
Detailed Description
Continuing care is believed to be important in the effective management of patients with alcohol use disorders. New smartphone technology provides a novel way to provide personalized continuing care support. Dr. Gustafson and colleagues at the University of Wisconsin have developed an addiction version of CHESS (ACHESS), an automated smart phone system that provides a range of functions designed to directly support patients. In a recently completed NIAAA-funded continuing care study, ACHESS produced better drinking outcomes with alcoholics than treatment as usual.
The Principal Investigator of the current study, Dr. Jim McKay, and his colleagues at the Center of Continuum of Care in the Addictions have also developed a telephone-based approach to continuing care, Telephone Monitoring and Counseling (TMC), which has demonstrated efficacy in two randomized trials with alcohol-dependent patients. The TMC intervention is delivered through telephone contacts between patients and counselors, and makes use of information obtained in a brief assessment at the beginning of each call to determine the content of the session and to trigger adaptive changes in level of care over time.
Although both ACHESS and TMC use telephone technology, they have complementary strengths. ACHESS provides a range of automated 24/7 recovery support services, but does not include contact with a counselor. TMC, on the other hand, provides regular and sustained contact with the same counselor, but does not provide support between calls. The future of continuing care for alcohol use disorders is likely to involve both automated mobile technology and counselor contact, but little is known about how best to integrate these services.
To address this question, the study will feature a 2 x 2 design [ACHESS for 12 months (yes/no) x TMC for 12 months (yes/no)]. With this design, we will determine whether adding TMC to ACHESS produces superior outcomes to those obtained with TMC or ACHESS alone. This design will also enable replication of prior findings, and will provide the first direct comparison of TMC only vs. ACHESS only. In addition, economic analyses will be completed to determine the cost and cost-effectiveness of each intervention and their combination. The participants will be randomly assigned into one of the four conditions and followed for 18 months. The follow-ups will be at 3, 6, 9, 12, and 18 months post-baseline.
The subjects will be 280 patients diagnosed with alcohol abuse who are in a substance abuse treatment center in the Philadelphia area.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Time Line Follow Back, Percent Heavy Alcohol Use
Time Frame: 18 month: months 13 - 18 post baseline
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.
Secondary Outcomes
No secondary outcomes reported