Cost Effectiveness of Combined Contingency Management and Cognitive Behavioral Therapy for Alcohol Use Disorder

Duke University

Status: Completed

Conditions: Veterans; Alcohol Drinking

Treatments: Behavioral: Mobile Contingency Management (mCM); Behavioral: Long-term incentive; Behavioral: Cognitive Behavioral Therapy (CBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03987581

PRO00101744

Details and patient eligibility

About

Alcohol contributes to 88,000 deaths and costs an estimated $223 billion annually in the United States. Alcohol use disorder (AUD) is highly prevalent in veterans. The positive public health impact of reducing heavy drinking among veterans with AUD would prevent significant medical morbidity and mortality. Contingency management (CM) is an intensive behavioral therapy that provides incentives to individuals for reducing substance use. Monitoring alcohol abstinence usually requires daily monitoring. Because of this difficulty, CM approaches for treatment of AUD are not currently available to people with AUD. Our group has developed a mobile smart-phone application that allows patients to video themselves using an alcohol breath monitor and transmit the encrypted data to a secure server. This innovation has made the use of CM for outpatient AUD treatment feasible. The aim of the current study is to evaluate the effectiveness and cost effectiveness of CM as an add-on to cognitive behavioral therapy for AUD. The trial will also explore the potential usefulness of a long-term abstinence incentive ontreatment utilization and alcohol outcomes. Proposed is a trial in which 140 veterans with AUD will be randomized to receive either CM as an add-on to evidence-based CBT or CBT alone. Veterans will also be randomized to one of two long-term incentive conditions (i.e., receipt of a monetary incentive for abstinence/low-risk drinking at 6- months vs. no incentive). This project aims to advance AUD treatment by 1) testing the effectiveness of a mobile health approach that makes CM for AUD feasible, and 2) providing highly needed cost-effectiveness data on the use of behavioral incentives as an adjunct to CBT for the treatment of AUD. These aims are designed to address two significant barriers to the implementation of CM for AUD.

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• are an enrolled veteran at the DVAHCS for primary care,
• have current AUD (meeting past month DSM-5 criteria), and
• are willing to make a quit attempt and/or reduce alcohol use to low risk levels.

Exclusion criteria

• have fewer than 3 days of abstinence,
• have a history of clinically significant alcohol withdrawal, as indicated by a score of 10 or more on the Clinical Institute Withdrawal Assessment of Alcohol (CIWA), or
• are currently receiving professional behavioral treatment for AUD.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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151 participants in 4 patient groups

CBT + mCM + incentive

Experimental group

Description:

Participants in this arm will receive 12 sessions of cognitive behavioral treatment, mobile contingency management for alcohol abstinence, and a monetary incentive for 30-day abstinence at the 6-month follow-up.

Treatment:

Behavioral: Long-term incentive

Behavioral: Cognitive Behavioral Therapy (CBT)

Behavioral: Mobile Contingency Management (mCM)

CBT + mCM + no incentive

Experimental group

Description:

Participants in this arm will receive 12 sessions of cognitive behavioral treatment and mobile contingency management for alcohol abstinence. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up.

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)

Behavioral: Mobile Contingency Management (mCM)

CBT alone + incentive

Experimental group

Description:

Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period.

Treatment:

Behavioral: Long-term incentive

Behavioral: Cognitive Behavioral Therapy (CBT)

CBT alone + no incentive

Active Comparator group

Description:

Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period.

Treatment:

Behavioral: Cognitive Behavioral Therapy (CBT)