2017 — 2019 |
Calhoun, Patrick S. Dedert, Eric A |
R34Activity Code Description: To provide support for the initial development of a clinical trial or research project, including the establishment of the research team; the development of tools for data management and oversight of the research; the development of a trial design or experimental research designs and other essential elements of the study or project, such as the protocol, recruitment strategies, procedure manuals and collection of feasibility data. |
Mobile Contingency Management For Concurrent Abstinence From Alcohol and Smoking
? DESCRIPTION (provided by applicant): Alcohol misuse and smoking constitute two of the three leading preventable causes of death in the United States. Reluctance to treat tobacco dependence among those with AUD is misguided as recent research suggests smoking cessation treatment can be effective, does not increase risk of relapse to alcohol, and may even improve rates of sobriety. There is strong evidence for the short-term efficacy for alcohol misuse and smoking of contingency management (CM). It is an intensive behavioral therapy that provides incentives (vouchers, money) to individuals misusing substances contingent upon objective evidence from drug use. Implementation of CM has been limited because of the need to verify abstinence multiple times daily using clinic based monitoring. Our group recently developed a smart-phone application which allows a patient to video themselves several times daily while using a small CO monitor and to transmit the data to a secure server which has made the use of CM for outpatient smoking cessation portable and feasible. Our mobile CM (mCM) approach paired with cognitive-behavioral counseling and pharmacological smoking cessation aids has been effective in reducing smoking. Thus, the purpose of this project is to develop and pilot-test a combined alcohol and smoking mCM intervention. Our long term goal is to develop mCM procedures that will be used as part of a multi-component intervention to concurrently and effectively treat both alcohol misuse and smoking. As part of this project, we will develop a multi-component telehealth alcohol and smoking mCM intervention. It will include mCM, cognitive-behavioral phone counseling, and standard smoking cessation pharmacotherapy. Three cohorts will provide data. The first cohort (n = 5) will yield primarily qualitative data from participants and therapists, which will be utilized to modify the treatment components including the therapist manual, participant workbook, mCM apps, and data collection procedures. The second cohort (n = 5) will yield qualitative and quantitative data to guide the focus of the intervention to components most valued by participants and linked with achieving outcome benchmarks. The third cohort will be a pilot clinical trial comparing the multi-component mCM intervention (n = 30) to a comparison condition (n = 15) that differs only in that reinforcement will not be contingent on abstinence. The work proposed in these aims will provide the first step toward implementation of an innovative approach that builds upon the power of mHealth technology to reduce the prevalence of both alcohol misuse and smoking.
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0.928 |
2019 |
Calhoun, Patrick S. Dedert, Eric A |
R01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
Effectiveness and Outcomes of Combined Contingency Management as An Adjunct to Cognitive Behavioral Therapy For Alcohol Use Disorders
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; an estimated 32% of veterans meet diagnostic criteria for AUD. The positive public health impact of reducing heavy drinking among veterans with AUD would prevent significant medical morbidity and mortality. Behavioral incentives could increase treatment retention and increase abstinence among Veterans with AUD. Contingency management (CM) is an intensive behavioral therapy that provides incentives to individuals misusing substances. CM has demonstrated effect sizes beyond that of other behavioral treatments across multiple drugs of abuse, including a trial in Veterans with AUD, which demonstrated that CM both increased treatment retention and completion rates and was associated with increased abstinenence from alcohol compared to standard treatment. To date, however, implementation of CM interventions has largely focused on stimulant use disorders (e.g., cocaine; methamphetamine) due to the diffculty of monitoring abstinence from alcohol, which requires daily monitoring. Thus, despite demonstrated efficacy, CM aproaches 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 a small FDA-approved alcohol breath monitor and transmits the encrypted data to a secure server. This innovation has made the use of CM for outpatient AUD treatment feasible. Targeting AUD with mobile CM (mCM) paired with evidenced-based cognitive behavioral therapy (CBT) will significantly improve long-term abstinence rates and reduction in heavy drinking days among Veterans with AUD. The aim of the current study is to evaluate the effectiveness and cost effectiveness of contingency management as an adjunct to cognitive behavioral therapy for alcohol use disorders. The trial will also explore the potential utilty of a long-term abstinence incentive on treatment utilization and alcohol outcomes. Proposed is a comparative effectiveness trial with a 2 x 2 factorial design in which 160 Veterans with AUD will be proactively recruited and randomized to receive either CM as an adjunct to state-of-the-art evidenced-based CBT or CBT alone; and to one of two long-term incentive conditions (i.e., receipt of a monetery 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 efficacious CM for AUD.
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0.928 |
2020 — 2021 |
Calhoun, Patrick S. Dedert, Eric A |
R01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
Effectiveness and Outcomes of Combined Contingency Management and Cbt For Alcohol Use Disorder
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; an estimated 32% of veterans meet diagnostic criteria for AUD. The positive public health impact of reducing heavy drinking among veterans with AUD would prevent significant medical morbidity and mortality. Behavioral incentives could increase treatment retention and increase abstinence among Veterans with AUD. Contingency management (CM) is an intensive behavioral therapy that provides incentives to individuals misusing substances. CM has demonstrated effect sizes beyond that of other behavioral treatments across multiple drugs of abuse, including a trial in Veterans with AUD, which demonstrated that CM both increased treatment retention and completion rates and was associated with increased abstinenence from alcohol compared to standard treatment. To date, however, implementation of CM interventions has largely focused on stimulant use disorders (e.g., cocaine; methamphetamine) due to the diffculty of monitoring abstinence from alcohol, which requires daily monitoring. Thus, despite demonstrated efficacy, CM aproaches 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 a small FDA-approved alcohol breath monitor and transmits the encrypted data to a secure server. This innovation has made the use of CM for outpatient AUD treatment feasible. Targeting AUD with mobile CM (mCM) paired with evidenced-based cognitive behavioral therapy (CBT) will significantly improve long-term abstinence rates and reduction in heavy drinking days among Veterans with AUD. The aim of the current study is to evaluate the effectiveness and cost effectiveness of contingency management as an adjunct to cognitive behavioral therapy for alcohol use disorders. The trial will also explore the potential utilty of a long-term abstinence incentive on treatment utilization and alcohol outcomes. Proposed is a comparative effectiveness trial with a 2 x 2 factorial design in which 160 Veterans with AUD will be proactively recruited and randomized to receive either CM as an adjunct to state-of-the-art evidenced-based CBT or CBT alone; and to one of two long-term incentive conditions (i.e., receipt of a monetery 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 efficacious CM for AUD.
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0.928 |
2021 |
Calhoun, Patrick S. Dedert, Eric A |
R01Activity Code Description: To support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing his or her specific interest and competencies. |
Cost Effectiveness of Combined Contingency Management and Cognitive Behavioral Therapy For Alcohol Use Disorder
The parent grant plans to examine the clinical and cost-effectiveness of cognitive-behavioral therapy (CBT) combined with contingency management (CM) in reducing problematic drinking in veterans who meet diagnostic criteria for alcohol use disorder (AUD). Research suggests that those with AUD and co-occurring suicidal thoughts and behaviors are more likely to respond poorly to AUD treatment and relapse on alcohol use. This is important, given that nearly half of those with AUD who present for AUD treatment report a history of suicidal behavior, and numerous studies indicate that those with co-occurring AUD and suicidal thoughts and behaviors tend to demonstrate more severe and chronic AUD symptoms. Despite the robust association between alcohol and suicide, and the extent that co-occurring suicidal thoughts and behaviors influences the presentation and treatment of AUD, little research has examined mechanisms underlying these associations. The proposed supplement would extend the parent grant study by testing the extent that ongoing suicidal thoughts and behaviors impact the progression of and response to CBT/CM for AUD, and examine if CBT/CM leads to reduction in suicide risk in veterans over time, thereby providing a further test of the clinical and cost effectiveness of CBT/CM for AUD (Aim 1). The proposed supplement would also involve secondary analyses of data from a recently conducted ecological momentary assessment (EMA) study on veterans at high-risk for suicide. This study, which was conducted over a 4-week period, involved veterans completing multiple brief surveys per day on a number of momentary variables, including daily alcohol use, momentary suicidal ideation, and other internal (e.g., affect) and contextual (e.g., daily stressors, interpersonal problems) variables. With these variables, the proposed supplement would use advanced longitudinal statistics to examine the extent that daily alcohol use leads to subsequent increase in suicidal thoughts, as well as if suicidal thoughts lead to increase in alcohol consumption, and explore moderators of these associations (Aim 2). While there have been several studies suggesting a dose response relationship between alcohol use and subsequent suicidal desires, the proposed supplement would be the first use EMA to examine the likely bidirectional and dynamic relationship between AUA and suicidal thoughts and behaviors. This will allow us to better understand how the co-occurring mental health problem of suicidal thoughts and behaviors perpetuates and worsens AUD symptoms in real life. Overall, improved understanding of longitudinal relationships between alcohol consumption and acute fluctuations in suicidal thoughts and behaviors in daily life and in the context of treatment significantly enhances the parent grant, and could be highly informative for the future modification and development of mobile health interventions with CBT/CM.
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0.928 |