A novel telemedicine intervention combining alcohol use disorder medication and therapy shows promise
Telemedicine can help overcome some of the barriers to accessing treatment for alcohol use disorder, but there are few that are empirically supported. This study examined the feasibility, acceptability, and preliminary outcomes of a novel telemedicine intervention for alcohol use disorder combining medication with talk therapy.
Evidenced-based therapies that are currently available for the treatment of alcohol use disorder include (but are not limited to) cognitive behavioral therapy and motivational enhancement therapy. One commonly prescribed FDA-approved medication for alcohol use disorder is naltrexone (brand names Revia and Vivitrol). Naltrexone works by blocking the rewarding effects of alcohol and is prescribed for people who seek pleasurable effects from binge drinking.
Combining therapy with medication is considered a best practice in the treatment of alcohol use disorder, and telemedicine delivered through mobile health technology can help overcome some of the barriers to traditional treatment previously mentioned by offering a more accessible, convenient, and private option. However, the few mobile health interventions that are available typically either offer therapy or medication. Accordingly, a mobile health intervention that combines both treatments could provide an innovation in the treatment of alcohol use disorder. This study evaluated the feasibility, acceptability, and preliminary outcomes of such a novel intervention for alcohol use disorder. While the study was a pilot that did not include a control group for comparison, this research can demonstrate the potential of the intervention in helping to reduce alcohol use among people with alcohol use disorder, thereby providing a rationale for larger experimental studies and ultimately contributing to the development of better and more accessible treatment options.
HOW WAS THIS STUDY CONDUCTED?
The research team examined the feasibility, acceptability, and preliminary outcomes of a novel telemedicine intervention delivered via smartphone application for alcohol use disorder that combines medication management with talk therapy. Twenty-six participants were enrolled in the 12-week intervention, during which they received cognitive behavioral therapy and naltrexone, a medication used to treat alcohol use disorder. The researchers were primarily interested in the clinical outcome of alcohol use, as well as treatment engagement and completion.
After participants’ eligibility was determined, they completed a baseline diagnostic assessment with a study counselor and a medical/physical assessment with a physician or nurse practitioner, who was assigned to them for medication management. Then, participants were scheduled for 12 weekly video-based counseling visits that were 45-minutes long, during which they received manualized, counselor-delivered cognitive behavioral therapy. They were also scheduled for 3 monthly medication visits, during which dosage, side effects, and treatment progress were reviewed and adjusted as needed. Participants were assessed at baseline and then monthly by a trained research assistant over the phone (for a total of 4 phone assessments). They also completed monthly self-report questionnaires electronically using a link that was emailed to them. At the end of the intervention, 9 participants were randomly selected to be interviewed online about their experience with the intervention.
The intervention, called the Quit Genius for Alcohol Use Disorder, is delivered through a mobile application that includes a video conferencing platform, interactive modules with therapeutic content, and a text chat function (i.e., similar to text messaging but through the application) so participants could chat with their counselor. Participants could choose their drinking goals, from cutting down on drinking to total abstinence.
The main clinical outcomes of interest were alcohol use during the past 30 days, defined as proportion of days abstinent and drinks per drinking day. Changes in the World Health Organization (WHO) drinking risk level from baseline to treatment-end were examined as a secondary outcome. WHO risk levels are defined by grams of alcohol consumed per day and range from level 0, defined as no alcohol consumed, to level 4 (the highest risk level), defined as more than 100 grams of alcohol per day for men (about 7 or more US standard drinks) and more than 60 grams per day for women (about 4 or more US standard drinks).Other outcomes of interest include depression, anxiety, and resilience, also measured at baseline and monthly thereafter. The researchers statistically analyzed differences in these clinical outcomes from baseline to the end of the study.
In addition, they were interested in acceptability of the intervention, which they defined as attending at least 2 of the monthly data collection visits, and treatment completion, defined as attending the week 12 data collection session conducted at the end of treatment. Finally, they measured perceived helpfulness of the intervention with a consumer feedback questionnaire.
Participants were recruited from social media advertisements. In order to be eligible for the study, participants had to: (1) be 18 years old or older; (2) reside in the United States; (3) own a smartphone with sufficient functionality to download and utilize the study app; (4) have a diagnosis of alcohol use disorder, as determined by the fifth edition of the Diagnostic and Statistical Manual (DSM-5); (5) be able and willing to participate in study procedures, including taking naltrexone (the study medication); and (6) be in good general health.
Participants were deemed not eligible for the study if they: (1) had a known sensitivity to naltrexone; (2) had a serious medical condition that would make participation dangerous; (3) required medical detoxification from any substances; (4) had used any medications for alcohol use disorder (acamprosate, disulfiram, or naltrexone) within the 30 days before screening; (5) were routinely taking opioid medication or anticipated surgery that would require opioid maintenance during the study; (6) had undergone medical detoxification more than once; (7) lacked English proficiency; or (8) had clinically significant psychiatric symptoms that would make study participation difficult.
Throughout the study period, 83 individuals were screened and asked to consent to the study, of whom 65 agreed. However, 39 of the 65 potential participants either did not complete the eligibility screening or were determined to be ineligible, leaving the total of 26 participants that were enrolled and received the intervention. Among these, participants were on average 45 years old and the majority were men (71%) who identified as white (68%). Most were also employed (67%) and had a high school or college education (71%). At baseline, participants reported drinking almost 26 days of the last 30 and drank an average of approximately 7 drinks per drinking day.
WHAT DID THIS STUDY FIND?
Most participants completed the treatment and found it helpful.
Treatment acceptability (i.e., attending at least 2 data collection visits) was 96%. On average, participants attended 9 of the 12 cognitive behavioral therapy sessions. Treatment completion was achieved by 85% of participants.
As far as perceived helpfulness of the intervention, 83% of participants agreed or strongly agreed that it helped them change their alcohol use and 95% would recommend the intervention to others (95%).
Participants reduced alcohol use and experienced improved mental health symptoms.
The proportion of days abstinent in the past 30 increased from a mean of 13.8% at baseline to 59% at week 12 (the end of treatment). Drinks per drinking day also declined from a mean of 6.7 at baseline to 2.7 at week 12. For WHO risk levels, 68% of participants significantly reduced their alcohol use by one or more risk levels from baseline to week 12, with 26% having reduced by 1 level and 42% by 2 or 3 levels.
Levels of depression declined from a mean of 8.3 (moderately severe) to 4.1 (mild) and anxiety levels declined from a mean of 7.1 (moderate) to 4.7 (mild) from baseline to week 12. Resilience levels also increased from a mean of 3.1 at baseline to 3.7 at week 12.
Longer engagement with the intervention was associated with better clinical outcomes.
Participants stayed engaged with the intervention for an average of 10.3 weeks. Those who were engaged for 9 weeks or longer were approximately 3 times more likely to have a good clinical outcome (i.e., proportion of days abstinent greater than or equal to 0.75 in the last 30 days before week 12) than those who were engaged for 8 weeks or less.
WHAT ARE THE IMPLICATIONS OF THE STUDY FINDINGS?
Researchers in this pilot study evaluated the feasibility, acceptability, and preliminary outcomes of a novel telemedicine intervention for alcohol use disorder that combines medication with therapy. Results showed that participants found the intervention to be acceptable and helpful in changing their alcohol use, with high completion rates. Preliminary clinical outcomes showed reductions in participants’ alcohol use and improvements in their mental health.
While this was a small pilot study that did not include a control group for comparison, these promising preliminary results help to support the rationale for additional studies to experimentally test telemedicine interventions that combine therapy and medicine for alcohol use disorder. If these studies further demonstrate that it can be helpful for reducing alcohol consumption and improving mental health among people with alcohol use disorder, it could contribute to the growing body of research supporting the clinical and public health utility of telemedicine for substance use disorders. Specifically, telemedicine interventions such as this one can potentially help address the traditionally low treatment engagement rates for alcohol use disorder by expanding access to treatment, as it removes some logistical barriers involving geographic location and transportation, as well as privacy concerns.
Further, because the telemedicine intervention is delivered through a smartphone app, as opposed to online through a computer, household broadband is not needed. This may allow for greater access to the treatment, since more Americans (85%) have a smartphone than have broadband at home (75%). Having broadband service at home is even lower among racial minorities and those with lower income and education levels. Delivering treatment through a smartphone app may therefore improve treatment access among these harder to reach populations.
Of note, the majority of the participants in this study were men. This is a common limiting challenge in research studies since alcohol use disorder affects more men than women, yet almost 1 in 5 women are still affected. However, prior research has shown that naltrexone may not be as helpful in treating alcohol use disorder among women as it is in men. This points to the need for future research to evaluate sex differences in treatment outcomes, especially given that women are more sensitive to the effects of alcohol and develop negative health consequences sooner.
Additionally, participants who attended more treatment sessions had better clinical outcomes than those attending fewer sessions. This is also common in alcohol use disorder treatment studies because it is reflective of their readiness and motivation to make changes in their drinking. Those who are ready and motivated to change are likely to be more engaged in treatment than those who are still contemplating changes or who are not ready.
The promising results of this small pilot study demonstrate preliminary support for a novel telemedicine intervention for alcohol use disorder that combines therapy and medication. Future research that further evaluates telemedicine’s effectiveness for alcohol use disorder may improve treatment rates and expand access, if shown to be a helpful treatment. Because mobile health interventions like these often include many components – clinician-delivered therapy, prescribed FDA-approved medication, 24/7 access to self-management modules, and text chat with clinicians in this study – research can also help to determine which elements of the treatment are having the greatest impact on patient benefits.
This study was a small pilot without a control group. This limits the extent to which we can directly attribute the results of the study to the intervention as we don’t know what would happen to similar individuals with just the passage of time.
Participants in the study were mostly men. It is unclear if the results will generalize to women. Given prior research showing that naltrexone may not be as helpful in treating alcohol use disorder among women as it is in men, it may be that other intervention approaches are needed for women.
Like most substance use disorder treatment studies, participants self-selected into the study. Accordingly, this group of people may be particularly motivated to decrease their alcohol use, thereby possibly limiting the extent to which the results will generalize to less motivated people with alcohol use disorder. Future research is needed to help determine this.
The follow-up period was only 12 weeks. Accordingly, it is unknown whether and for how long intervention effects will last.
Researchers in the study did not assess whether participants have previously received cognitive behavioral therapy or naltrexone. This may have biased the results by either inoculating them to treatment effects (making the intervention less helpful) or by making them more open to therapy (making the intervention more helpful), given their prior experience.
Similarly, the research team did not assess whether participants attended meetings held by mutual help organizations, such as Alcoholics Anonymous. It is therefore unclear whether and to what extent some of the benefits observed in the study are attributable to attendance at such meetings.
BOTTOM LINE
Preliminary results from this small pilot study evaluating a novel telemedicine intervention for alcohol use disorder that combines therapy and medication show that the intervention is feasible and holds promise as a way to reduce alcohol use and improve mental health. Larger experimental studies are needed to rigorously test its effectiveness before determining how helpful it ultimately is in treating alcohol use disorder.
For individuals and families seeking recovery: Results from this study suggest that individuals with alcohol use disorder who are seeking recovery may reduce their alcohol use when receiving therapy combined with medication, particularly if the treatment is delivered through a mobile app. While such telemedicine interventions are currently being developed and rigorously tested, individuals may take advantage of currently available treatments, while staying aware of new innovations in treatment and delivery approaches.
For treatment professionals and treatment systems: This study’s results preliminarily support the notion that telemedicine broadly may be helpful for treating alcohol use disorder. Treatment professionals and general medical systems who begin to offer telemedicine more frequently may see more patients with alcohol use disorder reduce their alcohol use. This could have a large clinical and public health impact, given that heavy alcohol use is causally implicated in more than 60 different diseases globally and accounts for more than 140,000 deaths annually in the United States. Professionals and systems who can offer treatment that combines therapy and medication may see their patients benefit in overall health and well-being as well as reduce health care utilization.
For scientists:While the current study preliminarily demonstrated the feasibility of a novel telemedicine intervention combining therapy and medication, and showed promising clinical outcomes, it was a small pilot study without a control group. Larger randomized controlled trials that rigorously test its effectiveness are needed to determine how helpful the intervention ultimately is for treating alcohol use disorder. Further, if future research examined treatment outcomes among women with alcohol use disorder, results could shed light on treatment approaches that are helpful for women specifically. The same is true of different age groups and other racial/ethnic groups. Finally, studies that go beyond the 12-week follow-up period in the present study will help determine how long results can last.
For policy makers: The current study was a small pilot study that showed promising results for a novel telemedicine intervention reducing alcohol use among participants with alcohol use disorder, providing a rationale for larger randomized controlled trials testing the effectiveness of telemedicine for the treatment of substance use disorders. Funding for such studies would help determine how useful telemedicine interventions can be for treating substance use disorders and hold great promise to increase the reach of helpful interventions to reduce alcohol-related harms and their impact in the population.
Evidenced-based therapies that are currently available for the treatment of alcohol use disorder include (but are not limited to) cognitive behavioral therapy and motivational enhancement therapy. One commonly prescribed FDA-approved medication for alcohol use disorder is naltrexone (brand names Revia and Vivitrol). Naltrexone works by blocking the rewarding effects of alcohol and is prescribed for people who seek pleasurable effects from binge drinking.
Combining therapy with medication is considered a best practice in the treatment of alcohol use disorder, and telemedicine delivered through mobile health technology can help overcome some of the barriers to traditional treatment previously mentioned by offering a more accessible, convenient, and private option. However, the few mobile health interventions that are available typically either offer therapy or medication. Accordingly, a mobile health intervention that combines both treatments could provide an innovation in the treatment of alcohol use disorder. This study evaluated the feasibility, acceptability, and preliminary outcomes of such a novel intervention for alcohol use disorder. While the study was a pilot that did not include a control group for comparison, this research can demonstrate the potential of the intervention in helping to reduce alcohol use among people with alcohol use disorder, thereby providing a rationale for larger experimental studies and ultimately contributing to the development of better and more accessible treatment options.
HOW WAS THIS STUDY CONDUCTED?
The research team examined the feasibility, acceptability, and preliminary outcomes of a novel telemedicine intervention delivered via smartphone application for alcohol use disorder that combines medication management with talk therapy. Twenty-six participants were enrolled in the 12-week intervention, during which they received cognitive behavioral therapy and naltrexone, a medication used to treat alcohol use disorder. The researchers were primarily interested in the clinical outcome of alcohol use, as well as treatment engagement and completion.
After participants’ eligibility was determined, they completed a baseline diagnostic assessment with a study counselor and a medical/physical assessment with a physician or nurse practitioner, who was assigned to them for medication management. Then, participants were scheduled for 12 weekly video-based counseling visits that were 45-minutes long, during which they received manualized, counselor-delivered cognitive behavioral therapy. They were also scheduled for 3 monthly medication visits, during which dosage, side effects, and treatment progress were reviewed and adjusted as needed. Participants were assessed at baseline and then monthly by a trained research assistant over the phone (for a total of 4 phone assessments). They also completed monthly self-report questionnaires electronically using a link that was emailed to them. At the end of the intervention, 9 participants were randomly selected to be interviewed online about their experience with the intervention.
The intervention, called the Quit Genius for Alcohol Use Disorder, is delivered through a mobile application that includes a video conferencing platform, interactive modules with therapeutic content, and a text chat function (i.e., similar to text messaging but through the application) so participants could chat with their counselor. Participants could choose their drinking goals, from cutting down on drinking to total abstinence.
The main clinical outcomes of interest were alcohol use during the past 30 days, defined as proportion of days abstinent and drinks per drinking day. Changes in the World Health Organization (WHO) drinking risk level from baseline to treatment-end were examined as a secondary outcome. WHO risk levels are defined by grams of alcohol consumed per day and range from level 0, defined as no alcohol consumed, to level 4 (the highest risk level), defined as more than 100 grams of alcohol per day for men (about 7 or more US standard drinks) and more than 60 grams per day for women (about 4 or more US standard drinks).Other outcomes of interest include depression, anxiety, and resilience, also measured at baseline and monthly thereafter. The researchers statistically analyzed differences in these clinical outcomes from baseline to the end of the study.
In addition, they were interested in acceptability of the intervention, which they defined as attending at least 2 of the monthly data collection visits, and treatment completion, defined as attending the week 12 data collection session conducted at the end of treatment. Finally, they measured perceived helpfulness of the intervention with a consumer feedback questionnaire.
Participants were recruited from social media advertisements. In order to be eligible for the study, participants had to: (1) be 18 years old or older; (2) reside in the United States; (3) own a smartphone with sufficient functionality to download and utilize the study app; (4) have a diagnosis of alcohol use disorder, as determined by the fifth edition of the Diagnostic and Statistical Manual (DSM-5); (5) be able and willing to participate in study procedures, including taking naltrexone (the study medication); and (6) be in good general health.
Participants were deemed not eligible for the study if they: (1) had a known sensitivity to naltrexone; (2) had a serious medical condition that would make participation dangerous; (3) required medical detoxification from any substances; (4) had used any medications for alcohol use disorder (acamprosate, disulfiram, or naltrexone) within the 30 days before screening; (5) were routinely taking opioid medication or anticipated surgery that would require opioid maintenance during the study; (6) had undergone medical detoxification more than once; (7) lacked English proficiency; or (8) had clinically significant psychiatric symptoms that would make study participation difficult.
Throughout the study period, 83 individuals were screened and asked to consent to the study, of whom 65 agreed. However, 39 of the 65 potential participants either did not complete the eligibility screening or were determined to be ineligible, leaving the total of 26 participants that were enrolled and received the intervention. Among these, participants were on average 45 years old and the majority were men (71%) who identified as white (68%). Most were also employed (67%) and had a high school or college education (71%). At baseline, participants reported drinking almost 26 days of the last 30 and drank an average of approximately 7 drinks per drinking day.
WHAT DID THIS STUDY FIND?
Most participants completed the treatment and found it helpful.
Treatment acceptability (i.e., attending at least 2 data collection visits) was 96%. On average, participants attended 9 of the 12 cognitive behavioral therapy sessions. Treatment completion was achieved by 85% of participants.
As far as perceived helpfulness of the intervention, 83% of participants agreed or strongly agreed that it helped them change their alcohol use and 95% would recommend the intervention to others (95%).
Participants reduced alcohol use and experienced improved mental health symptoms.
The proportion of days abstinent in the past 30 increased from a mean of 13.8% at baseline to 59% at week 12 (the end of treatment). Drinks per drinking day also declined from a mean of 6.7 at baseline to 2.7 at week 12. For WHO risk levels, 68% of participants significantly reduced their alcohol use by one or more risk levels from baseline to week 12, with 26% having reduced by 1 level and 42% by 2 or 3 levels.
Levels of depression declined from a mean of 8.3 (moderately severe) to 4.1 (mild) and anxiety levels declined from a mean of 7.1 (moderate) to 4.7 (mild) from baseline to week 12. Resilience levels also increased from a mean of 3.1 at baseline to 3.7 at week 12.
Longer engagement with the intervention was associated with better clinical outcomes.
Participants stayed engaged with the intervention for an average of 10.3 weeks. Those who were engaged for 9 weeks or longer were approximately 3 times more likely to have a good clinical outcome (i.e., proportion of days abstinent greater than or equal to 0.75 in the last 30 days before week 12) than those who were engaged for 8 weeks or less.
WHAT ARE THE IMPLICATIONS OF THE STUDY FINDINGS?
Researchers in this pilot study evaluated the feasibility, acceptability, and preliminary outcomes of a novel telemedicine intervention for alcohol use disorder that combines medication with therapy. Results showed that participants found the intervention to be acceptable and helpful in changing their alcohol use, with high completion rates. Preliminary clinical outcomes showed reductions in participants’ alcohol use and improvements in their mental health.
While this was a small pilot study that did not include a control group for comparison, these promising preliminary results help to support the rationale for additional studies to experimentally test telemedicine interventions that combine therapy and medicine for alcohol use disorder. If these studies further demonstrate that it can be helpful for reducing alcohol consumption and improving mental health among people with alcohol use disorder, it could contribute to the growing body of research supporting the clinical and public health utility of telemedicine for substance use disorders. Specifically, telemedicine interventions such as this one can potentially help address the traditionally low treatment engagement rates for alcohol use disorder by expanding access to treatment, as it removes some logistical barriers involving geographic location and transportation, as well as privacy concerns.
Further, because the telemedicine intervention is delivered through a smartphone app, as opposed to online through a computer, household broadband is not needed. This may allow for greater access to the treatment, since more Americans (85%) have a smartphone than have broadband at home (75%). Having broadband service at home is even lower among racial minorities and those with lower income and education levels. Delivering treatment through a smartphone app may therefore improve treatment access among these harder to reach populations.
Of note, the majority of the participants in this study were men. This is a common limiting challenge in research studies since alcohol use disorder affects more men than women, yet almost 1 in 5 women are still affected. However, prior research has shown that naltrexone may not be as helpful in treating alcohol use disorder among women as it is in men. This points to the need for future research to evaluate sex differences in treatment outcomes, especially given that women are more sensitive to the effects of alcohol and develop negative health consequences sooner.
Additionally, participants who attended more treatment sessions had better clinical outcomes than those attending fewer sessions. This is also common in alcohol use disorder treatment studies because it is reflective of their readiness and motivation to make changes in their drinking. Those who are ready and motivated to change are likely to be more engaged in treatment than those who are still contemplating changes or who are not ready.
The promising results of this small pilot study demonstrate preliminary support for a novel telemedicine intervention for alcohol use disorder that combines therapy and medication. Future research that further evaluates telemedicine’s effectiveness for alcohol use disorder may improve treatment rates and expand access, if shown to be a helpful treatment. Because mobile health interventions like these often include many components – clinician-delivered therapy, prescribed FDA-approved medication, 24/7 access to self-management modules, and text chat with clinicians in this study – research can also help to determine which elements of the treatment are having the greatest impact on patient benefits.
This study was a small pilot without a control group. This limits the extent to which we can directly attribute the results of the study to the intervention as we don’t know what would happen to similar individuals with just the passage of time.
Participants in the study were mostly men. It is unclear if the results will generalize to women. Given prior research showing that naltrexone may not be as helpful in treating alcohol use disorder among women as it is in men, it may be that other intervention approaches are needed for women.
Like most substance use disorder treatment studies, participants self-selected into the study. Accordingly, this group of people may be particularly motivated to decrease their alcohol use, thereby possibly limiting the extent to which the results will generalize to less motivated people with alcohol use disorder. Future research is needed to help determine this.
The follow-up period was only 12 weeks. Accordingly, it is unknown whether and for how long intervention effects will last.
Researchers in the study did not assess whether participants have previously received cognitive behavioral therapy or naltrexone. This may have biased the results by either inoculating them to treatment effects (making the intervention less helpful) or by making them more open to therapy (making the intervention more helpful), given their prior experience.
Similarly, the research team did not assess whether participants attended meetings held by mutual help organizations, such as Alcoholics Anonymous. It is therefore unclear whether and to what extent some of the benefits observed in the study are attributable to attendance at such meetings.
BOTTOM LINE
Preliminary results from this small pilot study evaluating a novel telemedicine intervention for alcohol use disorder that combines therapy and medication show that the intervention is feasible and holds promise as a way to reduce alcohol use and improve mental health. Larger experimental studies are needed to rigorously test its effectiveness before determining how helpful it ultimately is in treating alcohol use disorder.
For individuals and families seeking recovery: Results from this study suggest that individuals with alcohol use disorder who are seeking recovery may reduce their alcohol use when receiving therapy combined with medication, particularly if the treatment is delivered through a mobile app. While such telemedicine interventions are currently being developed and rigorously tested, individuals may take advantage of currently available treatments, while staying aware of new innovations in treatment and delivery approaches.
For treatment professionals and treatment systems: This study’s results preliminarily support the notion that telemedicine broadly may be helpful for treating alcohol use disorder. Treatment professionals and general medical systems who begin to offer telemedicine more frequently may see more patients with alcohol use disorder reduce their alcohol use. This could have a large clinical and public health impact, given that heavy alcohol use is causally implicated in more than 60 different diseases globally and accounts for more than 140,000 deaths annually in the United States. Professionals and systems who can offer treatment that combines therapy and medication may see their patients benefit in overall health and well-being as well as reduce health care utilization.
For scientists:While the current study preliminarily demonstrated the feasibility of a novel telemedicine intervention combining therapy and medication, and showed promising clinical outcomes, it was a small pilot study without a control group. Larger randomized controlled trials that rigorously test its effectiveness are needed to determine how helpful the intervention ultimately is for treating alcohol use disorder. Further, if future research examined treatment outcomes among women with alcohol use disorder, results could shed light on treatment approaches that are helpful for women specifically. The same is true of different age groups and other racial/ethnic groups. Finally, studies that go beyond the 12-week follow-up period in the present study will help determine how long results can last.
For policy makers: The current study was a small pilot study that showed promising results for a novel telemedicine intervention reducing alcohol use among participants with alcohol use disorder, providing a rationale for larger randomized controlled trials testing the effectiveness of telemedicine for the treatment of substance use disorders. Funding for such studies would help determine how useful telemedicine interventions can be for treating substance use disorders and hold great promise to increase the reach of helpful interventions to reduce alcohol-related harms and their impact in the population.
Evidenced-based therapies that are currently available for the treatment of alcohol use disorder include (but are not limited to) cognitive behavioral therapy and motivational enhancement therapy. One commonly prescribed FDA-approved medication for alcohol use disorder is naltrexone (brand names Revia and Vivitrol). Naltrexone works by blocking the rewarding effects of alcohol and is prescribed for people who seek pleasurable effects from binge drinking.
Combining therapy with medication is considered a best practice in the treatment of alcohol use disorder, and telemedicine delivered through mobile health technology can help overcome some of the barriers to traditional treatment previously mentioned by offering a more accessible, convenient, and private option. However, the few mobile health interventions that are available typically either offer therapy or medication. Accordingly, a mobile health intervention that combines both treatments could provide an innovation in the treatment of alcohol use disorder. This study evaluated the feasibility, acceptability, and preliminary outcomes of such a novel intervention for alcohol use disorder. While the study was a pilot that did not include a control group for comparison, this research can demonstrate the potential of the intervention in helping to reduce alcohol use among people with alcohol use disorder, thereby providing a rationale for larger experimental studies and ultimately contributing to the development of better and more accessible treatment options.
HOW WAS THIS STUDY CONDUCTED?
The research team examined the feasibility, acceptability, and preliminary outcomes of a novel telemedicine intervention delivered via smartphone application for alcohol use disorder that combines medication management with talk therapy. Twenty-six participants were enrolled in the 12-week intervention, during which they received cognitive behavioral therapy and naltrexone, a medication used to treat alcohol use disorder. The researchers were primarily interested in the clinical outcome of alcohol use, as well as treatment engagement and completion.
After participants’ eligibility was determined, they completed a baseline diagnostic assessment with a study counselor and a medical/physical assessment with a physician or nurse practitioner, who was assigned to them for medication management. Then, participants were scheduled for 12 weekly video-based counseling visits that were 45-minutes long, during which they received manualized, counselor-delivered cognitive behavioral therapy. They were also scheduled for 3 monthly medication visits, during which dosage, side effects, and treatment progress were reviewed and adjusted as needed. Participants were assessed at baseline and then monthly by a trained research assistant over the phone (for a total of 4 phone assessments). They also completed monthly self-report questionnaires electronically using a link that was emailed to them. At the end of the intervention, 9 participants were randomly selected to be interviewed online about their experience with the intervention.
The intervention, called the Quit Genius for Alcohol Use Disorder, is delivered through a mobile application that includes a video conferencing platform, interactive modules with therapeutic content, and a text chat function (i.e., similar to text messaging but through the application) so participants could chat with their counselor. Participants could choose their drinking goals, from cutting down on drinking to total abstinence.
The main clinical outcomes of interest were alcohol use during the past 30 days, defined as proportion of days abstinent and drinks per drinking day. Changes in the World Health Organization (WHO) drinking risk level from baseline to treatment-end were examined as a secondary outcome. WHO risk levels are defined by grams of alcohol consumed per day and range from level 0, defined as no alcohol consumed, to level 4 (the highest risk level), defined as more than 100 grams of alcohol per day for men (about 7 or more US standard drinks) and more than 60 grams per day for women (about 4 or more US standard drinks).Other outcomes of interest include depression, anxiety, and resilience, also measured at baseline and monthly thereafter. The researchers statistically analyzed differences in these clinical outcomes from baseline to the end of the study.
In addition, they were interested in acceptability of the intervention, which they defined as attending at least 2 of the monthly data collection visits, and treatment completion, defined as attending the week 12 data collection session conducted at the end of treatment. Finally, they measured perceived helpfulness of the intervention with a consumer feedback questionnaire.
Participants were recruited from social media advertisements. In order to be eligible for the study, participants had to: (1) be 18 years old or older; (2) reside in the United States; (3) own a smartphone with sufficient functionality to download and utilize the study app; (4) have a diagnosis of alcohol use disorder, as determined by the fifth edition of the Diagnostic and Statistical Manual (DSM-5); (5) be able and willing to participate in study procedures, including taking naltrexone (the study medication); and (6) be in good general health.
Participants were deemed not eligible for the study if they: (1) had a known sensitivity to naltrexone; (2) had a serious medical condition that would make participation dangerous; (3) required medical detoxification from any substances; (4) had used any medications for alcohol use disorder (acamprosate, disulfiram, or naltrexone) within the 30 days before screening; (5) were routinely taking opioid medication or anticipated surgery that would require opioid maintenance during the study; (6) had undergone medical detoxification more than once; (7) lacked English proficiency; or (8) had clinically significant psychiatric symptoms that would make study participation difficult.
Throughout the study period, 83 individuals were screened and asked to consent to the study, of whom 65 agreed. However, 39 of the 65 potential participants either did not complete the eligibility screening or were determined to be ineligible, leaving the total of 26 participants that were enrolled and received the intervention. Among these, participants were on average 45 years old and the majority were men (71%) who identified as white (68%). Most were also employed (67%) and had a high school or college education (71%). At baseline, participants reported drinking almost 26 days of the last 30 and drank an average of approximately 7 drinks per drinking day.
WHAT DID THIS STUDY FIND?
Most participants completed the treatment and found it helpful.
Treatment acceptability (i.e., attending at least 2 data collection visits) was 96%. On average, participants attended 9 of the 12 cognitive behavioral therapy sessions. Treatment completion was achieved by 85% of participants.
As far as perceived helpfulness of the intervention, 83% of participants agreed or strongly agreed that it helped them change their alcohol use and 95% would recommend the intervention to others (95%).
Participants reduced alcohol use and experienced improved mental health symptoms.
The proportion of days abstinent in the past 30 increased from a mean of 13.8% at baseline to 59% at week 12 (the end of treatment). Drinks per drinking day also declined from a mean of 6.7 at baseline to 2.7 at week 12. For WHO risk levels, 68% of participants significantly reduced their alcohol use by one or more risk levels from baseline to week 12, with 26% having reduced by 1 level and 42% by 2 or 3 levels.
Levels of depression declined from a mean of 8.3 (moderately severe) to 4.1 (mild) and anxiety levels declined from a mean of 7.1 (moderate) to 4.7 (mild) from baseline to week 12. Resilience levels also increased from a mean of 3.1 at baseline to 3.7 at week 12.
Longer engagement with the intervention was associated with better clinical outcomes.
Participants stayed engaged with the intervention for an average of 10.3 weeks. Those who were engaged for 9 weeks or longer were approximately 3 times more likely to have a good clinical outcome (i.e., proportion of days abstinent greater than or equal to 0.75 in the last 30 days before week 12) than those who were engaged for 8 weeks or less.
WHAT ARE THE IMPLICATIONS OF THE STUDY FINDINGS?
Researchers in this pilot study evaluated the feasibility, acceptability, and preliminary outcomes of a novel telemedicine intervention for alcohol use disorder that combines medication with therapy. Results showed that participants found the intervention to be acceptable and helpful in changing their alcohol use, with high completion rates. Preliminary clinical outcomes showed reductions in participants’ alcohol use and improvements in their mental health.
While this was a small pilot study that did not include a control group for comparison, these promising preliminary results help to support the rationale for additional studies to experimentally test telemedicine interventions that combine therapy and medicine for alcohol use disorder. If these studies further demonstrate that it can be helpful for reducing alcohol consumption and improving mental health among people with alcohol use disorder, it could contribute to the growing body of research supporting the clinical and public health utility of telemedicine for substance use disorders. Specifically, telemedicine interventions such as this one can potentially help address the traditionally low treatment engagement rates for alcohol use disorder by expanding access to treatment, as it removes some logistical barriers involving geographic location and transportation, as well as privacy concerns.
Further, because the telemedicine intervention is delivered through a smartphone app, as opposed to online through a computer, household broadband is not needed. This may allow for greater access to the treatment, since more Americans (85%) have a smartphone than have broadband at home (75%). Having broadband service at home is even lower among racial minorities and those with lower income and education levels. Delivering treatment through a smartphone app may therefore improve treatment access among these harder to reach populations.
Of note, the majority of the participants in this study were men. This is a common limiting challenge in research studies since alcohol use disorder affects more men than women, yet almost 1 in 5 women are still affected. However, prior research has shown that naltrexone may not be as helpful in treating alcohol use disorder among women as it is in men. This points to the need for future research to evaluate sex differences in treatment outcomes, especially given that women are more sensitive to the effects of alcohol and develop negative health consequences sooner.
Additionally, participants who attended more treatment sessions had better clinical outcomes than those attending fewer sessions. This is also common in alcohol use disorder treatment studies because it is reflective of their readiness and motivation to make changes in their drinking. Those who are ready and motivated to change are likely to be more engaged in treatment than those who are still contemplating changes or who are not ready.
The promising results of this small pilot study demonstrate preliminary support for a novel telemedicine intervention for alcohol use disorder that combines therapy and medication. Future research that further evaluates telemedicine’s effectiveness for alcohol use disorder may improve treatment rates and expand access, if shown to be a helpful treatment. Because mobile health interventions like these often include many components – clinician-delivered therapy, prescribed FDA-approved medication, 24/7 access to self-management modules, and text chat with clinicians in this study – research can also help to determine which elements of the treatment are having the greatest impact on patient benefits.
This study was a small pilot without a control group. This limits the extent to which we can directly attribute the results of the study to the intervention as we don’t know what would happen to similar individuals with just the passage of time.
Participants in the study were mostly men. It is unclear if the results will generalize to women. Given prior research showing that naltrexone may not be as helpful in treating alcohol use disorder among women as it is in men, it may be that other intervention approaches are needed for women.
Like most substance use disorder treatment studies, participants self-selected into the study. Accordingly, this group of people may be particularly motivated to decrease their alcohol use, thereby possibly limiting the extent to which the results will generalize to less motivated people with alcohol use disorder. Future research is needed to help determine this.
The follow-up period was only 12 weeks. Accordingly, it is unknown whether and for how long intervention effects will last.
Researchers in the study did not assess whether participants have previously received cognitive behavioral therapy or naltrexone. This may have biased the results by either inoculating them to treatment effects (making the intervention less helpful) or by making them more open to therapy (making the intervention more helpful), given their prior experience.
Similarly, the research team did not assess whether participants attended meetings held by mutual help organizations, such as Alcoholics Anonymous. It is therefore unclear whether and to what extent some of the benefits observed in the study are attributable to attendance at such meetings.
BOTTOM LINE
Preliminary results from this small pilot study evaluating a novel telemedicine intervention for alcohol use disorder that combines therapy and medication show that the intervention is feasible and holds promise as a way to reduce alcohol use and improve mental health. Larger experimental studies are needed to rigorously test its effectiveness before determining how helpful it ultimately is in treating alcohol use disorder.
For individuals and families seeking recovery: Results from this study suggest that individuals with alcohol use disorder who are seeking recovery may reduce their alcohol use when receiving therapy combined with medication, particularly if the treatment is delivered through a mobile app. While such telemedicine interventions are currently being developed and rigorously tested, individuals may take advantage of currently available treatments, while staying aware of new innovations in treatment and delivery approaches.
For treatment professionals and treatment systems: This study’s results preliminarily support the notion that telemedicine broadly may be helpful for treating alcohol use disorder. Treatment professionals and general medical systems who begin to offer telemedicine more frequently may see more patients with alcohol use disorder reduce their alcohol use. This could have a large clinical and public health impact, given that heavy alcohol use is causally implicated in more than 60 different diseases globally and accounts for more than 140,000 deaths annually in the United States. Professionals and systems who can offer treatment that combines therapy and medication may see their patients benefit in overall health and well-being as well as reduce health care utilization.
For scientists:While the current study preliminarily demonstrated the feasibility of a novel telemedicine intervention combining therapy and medication, and showed promising clinical outcomes, it was a small pilot study without a control group. Larger randomized controlled trials that rigorously test its effectiveness are needed to determine how helpful the intervention ultimately is for treating alcohol use disorder. Further, if future research examined treatment outcomes among women with alcohol use disorder, results could shed light on treatment approaches that are helpful for women specifically. The same is true of different age groups and other racial/ethnic groups. Finally, studies that go beyond the 12-week follow-up period in the present study will help determine how long results can last.
For policy makers: The current study was a small pilot study that showed promising results for a novel telemedicine intervention reducing alcohol use among participants with alcohol use disorder, providing a rationale for larger randomized controlled trials testing the effectiveness of telemedicine for the treatment of substance use disorders. Funding for such studies would help determine how useful telemedicine interventions can be for treating substance use disorders and hold great promise to increase the reach of helpful interventions to reduce alcohol-related harms and their impact in the population.