Clinical trial NCT02681406: Smartphone Based Continuing Care for Alcohol
Official title: Impact of Enhancements to Smartphone Based Continuing Care for Alcohol Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

The risks of the research are conceived to be minimal (e.g., possible embarrassment) and consist of those incurred in providing self-report data on alcohol and drug-related history and social and psychiatric problems. There are minimal medical risks associated with research participation. There will be some risk of loss of confidentiality since the name, addresses and phone numbers of three contact people will be recorded by the staff for subject tracking purposes. However, all identifiable information will remain in a locked filling cabinet only accessible by the principle investigator and study staff. No identifying information will be programmed into the phone by the counselor. Although the participant is able to program numbers into the smartphone once they receive one, the counselor will review several measures for protecting the subjects' privacy, including password and pattern locks. All subjects will receive at a minimum treatment as usual in the programs from which they will be recruited.

Eligibility criteria: 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

Primary outcomes:
measure: Time Line Follow Back, Percent Heavy Alcohol Use
timeFrame: 18 month: months 13 - 18 post baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: James R. McKay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.