Clinical Trials Logo

Clinical Trial Summary

The study is designed to develop and test a tailored adaptive text messaging/short message service (SMS) intervention for individuals interested in reducing their alcohol consumption. According to the National Institute on Alcohol Abuse and Alcoholism, problem or risky drinking is defined as greater than 7 standard drinks per week for women and 14 standard drinks per week for men. Other groups have other criteria (e.g., 10 drinks for women and 14 for men per week). The Institute of Medicine reports that problem drinkers are those with mild-to-moderate problem severity who do not have physical dependence. Heavy drinking individuals with non-abstinence goals rarely seek treatment for excessive alcohol use, and newer methods such as internet screening and mobile apps provide opportunities to engage and treat this difficult to reach population. There are now 96 mobile phone contracts for every 100 people on earth, making mobile interventions a highly viable method for extending care beyond traditional methods. Text messaging or short message service (SMS) is the most widely available mode of mobile communication and despite its simplicity, has been proven to be a reliable and effective method to induce behavior change across behavioral health targets, including problem drinking. However, large scale randomized controlled trials are needed to provide the necessary empirical evidence to validate SMS interventions and understand the mediators and moderators of outcome for help seeking heavy drinkers who are using or unable to attend in-person care.


Clinical Trial Description

The study entitled, Tailored Adaptive Mobile Messaging to Reduce Problem Drinking (PD) is designed to develop and test a tailored adaptive text messaging/short message service (SMS) intervention for individuals interested in reducing their alcohol consumption. According to the National Institute on Alcohol Abuse and Alcoholism, problem or risky drinking is defined as greater than 7 standard drinks per week for women and 14 standard drinks per week for men. Other groups have other criteria (e.g., 10 drinks for women and 14 for men per week). The Institute of Medicine reports that problem drinkers are those with mild-to-moderate problem severity who do not have physical dependence. Heavy drinking individuals with non-abstinence goals rarely seek treatment for excessive alcohol use, and newer methods such as internet screening and mobile apps provide opportunities to engage and treat this difficult to reach population. There are now 96 mobile phone contracts for every 100 people on earth, making mobile interventions a highly viable method for extending care beyond traditional methods. Text messaging or short message service (SMS) is the most widely available mode of mobile communication and despite its simplicity, has been proven to be a reliable and effective method to induce behavior change across behavioral health targets, including problem drinking. However, large scale randomized controlled trials are needed to provide the necessary empirical evidence to validate SMS interventions and understand the mediators and moderators of outcome for help seeking heavy drinkers who are using or unable to attend in-person care. The investigators recently completed an R34 study to develop the first automated tailored adaptive (TA) text messaging intervention for problem drinking (PD) adults (Muench et al. 2017). The study compared TA to different automated once a day static messaging including: tailored only messaging (TO), loss framed messaging (LF), gain frame messaging (GF), and weekly mobile assessment only (MA) over 12 weeks in 171 problem drinkers recruited on the internet across the US. All messaging groups outperformed MA on most drinking outcomes, and the TA group had the largest effect sizes on every drinking outcome, with an average weekly drink reduction of 9 standard drinks at week 12. Over an 8-month period, 1149 individuals across the country took the web-based screening survey, highlighting the demand for messaging in this population. Furthermore, 94.7% of participants (Ps) enrolled completed the end of messaging week 12 survey and 80% wanted to continue messaging following the pilot trial. There were no adverse events in this study. Primary hypotheses: 1. The TA group will have significantly reduced weekly sum of standard drinks (SSD) and heavy drinking days (HDD) compared to MA at all time periods. 2. TO will have significantly reduced SSD and HDD compared to MA at all time points. 3. TA group will have significantly reduced SSD compared to TO at all time periods except one month follow-up. 4. Severity will moderate the relationship between TA, MA and TO and drinking in that high severity P's will make significantly greater changes in the TA group. Exploratory aims include testing other outcomes such as drinking related consequences by group, moderators such as gender and ethnicity, and mediators such as intervention relevance and self-efficacy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03695653
Study type Interventional
Source Partnership to End Addiction
Contact
Status Active, not recruiting
Phase N/A
Start date May 24, 2019
Completion date November 1, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05054738 - CRP and S&A for Inpatient Veterans N/A
Completed NCT02233738 - Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services N/A
Completed NCT05877807 - Effect of Baclofen to Prevent Post-Traumatic Stress Disorder
Completed NCT00000437 - Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone) Phase 4
Completed NCT00536146 - The Stress-Hormone System in Alcohol-Dependent Subjects N/A
Terminated NCT00890149 - Ondansetron for the Treatment of Heavy Drinking Among Emerging Adults Phase 2
Completed NCT02939352 - The Effects of Theta Burst Stimulation on the Brain Response to Drug and Alcohol Cues Early Phase 1
Completed NCT02179749 - Mifepristone Treatment of Alcohol Use Disorder Phase 2
Terminated NCT01408641 - Topiramate for Alcohol Use in Posttraumatic Stress Disorder N/A
Completed NCT01553136 - Varenicline Treatment of Alcohol Dependence in Smokers Phase 2
Completed NCT01389297 - Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery N/A
Completed NCT01113164 - Matching Genotypes and Serotonergic Medications for Alcoholism Phase 1
Completed NCT00768508 - Combined Pharmacotherapies for Alcoholism Phase 3
Completed NCT01760785 - Valproate for Mood Swings and Alcohol Use Following Head Injury N/A
Completed NCT00127231 - Brief Therapy Intervention for Heavy/Hazardous Drinking in HIV-Positive Women N/A
Terminated NCT02842528 - Cognitive Vulnerability Factors in Alcohol-dependence N/A
Completed NCT00367575 - An Internet-based Intervention for Problem Drinking N/A
Completed NCT00583440 - 12-step Facilitation for the Dually Diagnosed Phase 1/Phase 2
Completed NCT00223639 - New Medications to Treat Alcohol Dependence Phase 2
Completed NCT00167687 - Prazosin Alcohol Dependence IVR Study Phase 4