Mobile App for Alcoholism and Anxiety

Overseen By Brooke Y Kauffman, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michael J. Zvolensky, Ph.D.

Must not be taking: Anxiety medications, Antidepressants

Disqualifiers: Substance use program, Psychotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new mobile app, Aliento, designed to help Latinx individuals who speak Spanish manage anxiety and reduce risky drinking habits. The app provides personalized feedback to increase awareness of the connection between anxiety and alcohol use, encouraging healthier choices. Suitable participants identify as Latinx, are fluent in Spanish, experience clinical anxiety, and have patterns of hazardous drinking. Participants must have an Android smartphone to access the app. As an unphased trial, this study offers a unique opportunity to contribute to the development of a culturally tailored tool that could benefit the Latinx community.

Will I have to stop taking my current medications?

Yes, you cannot participate if you are currently using medication for anxiety or depression.

What prior data suggests that this mobile app is safe for Latinx hazardous drinkers with clinical anxiety?

Research has shown that smartphone apps for alcohol use disorder are generally safe. These apps help users track their drinking habits and offer strategies to reduce risks associated with drinking. Although earlier tests have not provided specific safety data for the Aliento app, its focus on education and motivation suggests it is safe for users. Designed for Latinx individuals with anxiety who engage in risky drinking, the app aims to be culturally relevant and supportive. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Aliento because it offers a fresh approach to managing alcoholism and anxiety through a mobile health application. Unlike traditional treatments that often require in-person therapy or medication, Aliento provides a digital intervention that users can access anytime and anywhere, promoting convenience and accessibility. This app-based method empowers individuals to engage with therapeutic content at their own pace, potentially enhancing adherence and personalization in treatment. Additionally, the intervention only takes about 30 minutes at the start and offers continuous support for up to three months, allowing users to integrate helpful strategies into their daily lives more seamlessly.

What evidence suggests that this mobile app is effective for alcoholism and anxiety?

Research has shown that mobile apps for alcohol use problems can help by tracking drinking habits and finding ways to reduce consumption. In this trial, participants will use Aliento, a mobile app specifically designed for Latinx individuals to help them understand the connection between drinking and anxiety. The app provides personalized feedback to enhance understanding and motivate users to reduce drinking. Early results suggest that these personalized tools can lead to positive behavior changes. This method specifically targets Latinx individuals who drink heavily and experience anxiety issues. ^{2 3 4 6 7}

Who Is on the Research Team?

Michael J Zvolensky

Principal Investigator

University of Houston

Are You a Good Fit for This Trial?

This trial is for Latinx or Hispanic adults over 21 who drink hazardously and have clinical anxiety. Participants must speak Spanish fluently, own an Android smartphone, and be willing to consent in writing. Those using medication for anxiety/depression, in psychotherapy, or substance use programs cannot join.

Inclusion Criteria

You identify yourself as being of Latinx or Hispanic origin.

21 years of age or older

You currently drink alcohol in a dangerous or harmful way.

Exclusion Criteria

You are currently taking medication for anxiety or depression.

current engagement in psychotherapy for anxiety or depression

You are currently participating in a program to address your alcohol or substance use.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (telephone)

Intervention

Participants complete a brief (~30 minute) personalized feedback intervention via a mobile health application

1 session

1 visit (in-person)

Follow-up

Participants are monitored for feasibility, acceptability, and initial effects of the intervention

3 months

3 visits (remote)

What Are the Treatments Tested in This Trial?

Interventions

• Aliento

Trial Overview The study is testing 'Aliento', a Spanish language mobile app designed for Android phones. It aims to educate users about the negative effects of mixing anxiety with alcohol use, motivate them to reduce hazardous drinking, and change their attitudes towards using alcohol to cope with anxiety.

How Is the Trial Designed?

Group I: Aliento Experimental Treatment 1 Intervention

Participants complete the brief (\~30 minute) intervention at baseline and will have access to intervention material for up to 3-months after the baseline appointment via the mobile health application.

Who Is Running the Clinical Trial?

Michael J. Zvolensky, Ph.D.

Lead Sponsor

Trials

1

Recruited

50+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

The 'Quest' app, designed for relapse prevention in patients with alcohol dependence syndrome, received high usability (5.8 out of 7) and acceptability (65%) ratings from users, indicating it is user-friendly and well-received.

While both groups (those using the Quest app and those receiving standard treatment) showed a significant reduction in drinking days over three months, there was no notable difference in relapse rates or heavy drinking days between the two groups, suggesting the app's effectiveness needs further validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design, development and pilot testing of 'Quest', a smartphone-based relapse prevention app for patients with alcohol dependence. Sharma, AK., Shadakshari, D., Chand, P., et al.[2023]

A 12-week integrated intervention combining cognitive behavioral therapy for alcohol dependence and comorbid anxiety/depression was more effective than usual counseling, leading to fewer days of relapse and lapse among patients.

The treatment significantly improved the percentage of days of abstinence, with the effectiveness particularly linked to reductions in anxiety symptoms, highlighting the importance of addressing both alcohol use and mental health issues together.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Specialized Integrated Treatment for Comorbid Anxiety, Depression and Alcohol Dependence Better than Treatment as Usual in a Public Hospital Setting? Morley, KC., Baillie, A., Leung, S., et al.[2018]

In a clinical trial involving alcoholics, reduced anxiety levels during treatment were found to significantly predict better drinking outcomes, with participants who experienced less anxiety reporting fewer drinks per day.

The study utilized a factorial design with various doses of ondansetron and included cognitive behavioral therapy, highlighting that both anxiety reduction and medication dosage play important roles in improving drinking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of anxiety in predicting drinking behaviour. Sloan, TB., Roache, JD., Johnson, BA.[2019]

A review identified six smartphone apps aimed at reducing alcohol consumption or treating alcohol use disorder (AUD), with only two apps (A-CHESS and LBMI-A) showing self-reported reductions in alcohol use.

The study highlights a significant gap in the evaluation of these apps, indicating that while smartphone technology has potential for aiding individuals with AUD, more rigorous testing is needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone applications to reduce alcohol consumption and help patients with alcohol use disorder: a state-of-the-art review. Meredith, SE., Alessi, SM., Petry, NM.[2022]

This study will evaluate the effectiveness of a gamified alcohol attentional control training program (AACTP) in enhancing treatment outcomes for 317 patients with alcohol use disorder (AUD) compared to standard treatment alone.

The research aims to show that incorporating AACTP into traditional alcohol treatment can lead to greater reductions in alcohol craving and consumption, potentially providing a new, low-cost intervention for clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of Attentional Control Training for Treating Alcohol Use Disorder. Mellentin, AI., Cox, WM., Fadardi, JS., et al.[2021]

Participants in a study of 21 individuals with alcohol dependence found that self-monitoring apps like 'Glasklart' and 'iBAC' helped increase awareness of their drinking habits and motivated them to change, enhancing their treatment experience.

Despite the benefits, the use of these apps was hindered by technical issues and feelings of shame related to alcohol use, suggesting that while they can be effective tools, improvements are needed for better user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Keeping Track of My Drinking - Patient Perceptions of Using Smartphone Applications as a Treatment Complement for Alcohol Dependence. Östh, J., Danielsson, AK., Lundin, A., et al.[2023]

A study involving 59 patients with alcohol use disorder showed that supportive text messaging after treatment can significantly extend the time before a patient has their first drink, with the intervention group averaging about 60 days compared to 26 days for the control group.

The text messaging intervention also demonstrated small to moderate improvements in cumulative abstinence duration and alcohol consumption, indicating it could be a valuable follow-up care tool for patients after residential treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled pilot trial of supportive text messaging for alcohol use disorder patients. Agyapong, VIO., Juhás, M., Mrklas, K., et al.[2019]

The smartphone-based intervention aimed at reducing risky drinking in young adults did not significantly decrease risky drinking behaviors or related harms, based on a pilot study involving 45 participants.

However, the intervention successfully increased the use of protective behavioral strategies among users, and participants rated the app as highly usable, indicating potential for future improvements in harm-minimization approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering Personalized Protective Behavioral Drinking Strategies via a Smartphone Intervention: a Pilot Study. O'Donnell, R., Richardson, B., Fuller-Tyszkiewicz, M., et al.[2020]

The pilot trial involving 89 participants showed that the TeleCoach app led to significant reductions in alcohol consumption over 6 weeks, with a large effect size (Cohen's d of 1.37) for the intervention group.

While the TeleCoach app demonstrated positive within-group effects, there were no significant differences between the app and the control group, suggesting further research with a larger sample size (up to 1,000 participants) is needed to fully evaluate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Risky Alcohol Use via Smartphone App Skills Training Among Adult Internet Help-Seekers: A Randomized Pilot Trial. Berman, AH., Molander, O., Tahir, M., et al.[2022]

A study involving 107 male alcohol abusers at a Veterans Administration Medical Center found significant differences in state and trait anxiety scores before and after treatment, indicating that treatment can effectively reduce anxiety levels.

The use of the State-Trait Anxiety Inventory (STAI-Y) is appropriate for assessing anxiety in alcoholic inpatients, providing valuable normative data for future research and treatment evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety in an alcoholic population: a normative study. Ludenia, K., Donham, GW., Holzer, PD., et al.[2019]

In a study of 82 individuals undergoing alcoholism treatment, those with a comorbid anxiety disorder (about 55% of participants) were significantly more likely to relapse into drinking within 120 days after treatment, highlighting the importance of addressing anxiety in these patients.

Specifically, social phobia was identified as the strongest predictor of any drinking relapse, while panic disorder was the best predictor of relapse to alcohol dependence, suggesting that certain anxiety disorders may have a more pronounced impact on recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up study of anxiety disorder and alcohol dependence in comorbid alcoholism treatment patients. Kushner, MG., Abrams, K., Thuras, P., et al.[2022]

In a study of 865 adults with alcohol use disorder (AUD), it was found that subclinical anxiety symptoms significantly influenced drinking behavior during and after treatment, indicating a complex relationship between anxiety and alcohol use.

Higher anxiety levels during treatment were associated with decreased drinking over time, suggesting that addressing anxiety may be important in improving treatment outcomes for AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trajectories of change in subclinical anxiety and alcohol use during alcohol treatment: A parallel process growth model. Hurlocker, MC., Carlon, H., Pearson, MR., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-alcohol-abuse-4-2022-df22b

Mobile App for Alcoholism and Anxiety The research on smartphone apps for alcohol use disorder suggests they are generally safe, as they focus on self-monitoring and harm reduction strategies.

2. reporter.nih.gov reporter.nih.gov/project-details/10850867

Latinx Hazardous Drinkers with Clinical Anxiety The current application aligns with the goals of RFA- AA-21-001 by proposing to examine the effectiveness of a low cost, highly disseminatable, personalized, ...

3. adaa.trialstoday.org adaa.trialstoday.org/list/print/NCT05288699

Anxiety & Depression Association of America Mobile App for Latinx Hazardous Drinkers With Clinical Anxiety. Purpose. The purpose of this study is to develop and examine a culturally ...

4. clinconnect.io clinconnect.io/trials/NCT05288699

Mobile App for Latinx Hazardous Drinkers With Clinical The app, which will be available in Spanish, aims to help users understand how their drinking may be affecting their anxiety and provide personalized feedback ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06416059

A Mobile Intervention for Black Individuals Who Engage in ... The application uses a personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05288699?tab=history&a=7

Mobile App for Latinx Hazardous Drinkers With Clinical Anxiety The 7-item Alcohol Attitudes Scale will be utilized to measure maladaptive attitudes for drinking (e.g., "Drinking alcohol is good"). Items are rated on a ...

7. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05288699?keyword=%22Hispanic%22

Mobile App for Latinx Hazardous Drinkers With Clinical Anxiety Finally, Latinx hazardous drinkers with clinical anxiety will be recruited to complete the final prototype of the mobile health application in order to evaluate ...