Mobile App for Reducing Pain and Heavy Drinking

Overseen By Maya Kratzer, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University Charles River Campus

Disqualifiers: Bipolar, Schizophrenia, Psychotic, others

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

Compensation: Varies

Number of Visits: 12

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app designed to help people with both chronic pain and heavy drinking habits. The app, called mhealth-pc, offers a new way to manage these issues together, especially for those in rural areas. The study will evaluate the practicality and effectiveness of this approach in real-life settings. It seeks participants who have experienced chronic pain for at least three months and consume alcohol beyond the recommended weekly limits. As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions for managing chronic pain and drinking habits.

Do I have to stop taking my current medications for the trial?

You can continue taking your current medications if you have been on the same dose for at least 2 months and are willing to keep using them as prescribed during the trial.

What prior data suggests that this mobile app is safe for reducing pain and heavy drinking?

Research shows that mobile health apps designed to reduce alcohol use are generally safe. Most people find them easy to use and helpful for managing their drinking habits. Studies on similar apps report very few negative side effects, indicating that most people tolerate them well. Users often say these tools fit easily into their daily lives.

Specific safety data for the mhealth-pc app in this trial is not yet available. However, similar apps for reducing pain and alcohol use have shown positive results with few problems. This suggests that the app under consideration for the trial is likely safe, based on experiences with similar technology. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mobile health intervention delivered through an app for reducing pain and heavy drinking because it offers a unique, tech-driven approach to managing these conditions. Unlike traditional treatments like medications or therapy sessions that require in-person visits, this app provides users with a convenient, on-the-go solution. The app can deliver personalized interventions and track progress in real-time, making it easier for users to stay engaged and motivated. This innovative approach could increase accessibility and adherence, potentially leading to better outcomes for users struggling with pain and heavy alcohol use.

What evidence suggests that this mobile app is effective for reducing pain and heavy drinking?

Research has shown that mobile health (mHealth) apps can effectively reduce both pain and risky drinking. In several studies focused on reducing alcohol use, nine out of ten reported positive results with mobile apps, indicating that digital tools can help people drink less. Other studies have developed mobile health programs that manage pain and reduce risky drinking. In this trial, participants will either receive a mobile app intervention designed to address these issues or join an assessment-only control group. These findings suggest that a smartphone app could be a promising way to help people struggling with both chronic pain and heavy drinking. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals who experience chronic pain and engage in heavy drinking. It's designed to test a smartphone-based intervention aimed at reducing both pain and alcohol consumption. Participants from rural areas are included to provide diverse data on the intervention's utility.

Inclusion Criteria

Heavy drinking by NIAAA guidelines (weekly limits [> 7 standard drinks for women or men age 65+, > 14 for men younger than 65], and/or a heavy drinking episode in the past month [>3 for women or men age 65+, > 4 for men younger than 65]) or by a positive USAUDIT-C score

I have had chronic pain for at least 3 months, rated 4 or higher.

Exclusion Criteria

Patients with bipolar disorder, schizophrenia, other psychotic disorder, or current suicidal intent

I have pain related to my cancer.

If on medication for pain or alcohol, not on same dose for at least 2 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a smartphone-based intervention for reducing pain and alcohol use

8 weeks

Mobile app usage

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Assessment at 12 weeks following baseline

What Are the Treatments Tested in This Trial?

Interventions

• mhealth-pc

Trial Overview The study is testing 'mhealth-pc', a mobile app-based approach, to see if it can help people with chronic pain reduce their hazardous drinking habits. The focus is on how feasible and acceptable this technology is for patients in primary care settings.

How Is the Trial Designed?

Group I: Mobile App Intervention Experimental Treatment 1 Intervention

Mobile health intervention delivered through an app

Group II: Control Active Control 1 Intervention

Assessment Only Control condition

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials

125

Recruited

14,100+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

A pilot study involving 21 OEF/OIF veterans showed that the Step Away app was easy to use and helped increase users' awareness of their alcohol consumption, which is crucial for reducing unhealthy drinking habits.

Participants appreciated features like daily assessments and personalized feedback, indicating that these elements could enhance engagement and motivate users to change their drinking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

U.S. veterans' experiences and factors associated with use of a smartphone application to self-manage unhealthy alcohol use. Hawkins, EJ., Lott, AM., Danner, AN., et al.[2023]

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 survey of 139 participants showed strong interest in using a mobile health application that monitors blood alcohol concentration (BAC) through gait analysis, indicating potential for reducing risky drinking behaviors.

Participants expressed a desire for control over app features, with adults preferring the option to disable BAC monitoring, while females favored mandatory notifications and safety features, highlighting the importance of user preferences in app design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User-centered preferences for a gait-informed alcohol intoxication app. Borges, A., Caviness, C., Abrantes, AM., et al.[2023]

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]

A systematic review of 22 controlled trials found that mobile health applications targeting substance use disorders can effectively reduce substance use, with eight applications showing significant reductions in usage among participants.

Most applications focused on educating users about the risks of substance use and managing cravings, suggesting that addressing cravings is crucial for preventing relapse, although the studies were limited by short durations and variability in their designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inventory and Analysis of Controlled Trials of Mobile Phone Applications Targeting Substance Use Disorders: A Systematic Review. Bahadoor, R., Alexandre, JM., Fournet, L., et al.[2021]

A study involving 99 young adults showed that using mobile health technologies, like a smartphone breathalyzer and a BAC estimator app, was feasible and well-accepted for moderating drinking habits.

Participants reported a significant reduction in alcohol consumption during a 2-week field test, using the technologies on 67% of drinking days, suggesting these tools may help reduce heavy drinking among young adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A combined laboratory and field test of a smartphone breath alcohol device and blood alcohol concentration estimator to facilitate moderate drinking among young adults. Leeman, RF., Berey, BL., Frohe, T., et al.[2023]

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]

The Drinkaware app, used by over 119,000 people in a 13-month study, effectively supports behavior change in motivated users, leading to reduced alcohol consumption, especially within the first week of use.

Despite its effectiveness, the app experienced high user drop-off after one week, indicating a need for greater personalization and tailored features to enhance long-term engagement and satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a mobile health application to reduce alcohol consumption: a mixed-methods evaluation of the drinkaware track & calculate units application. Attwood, S., Parke, H., Larsen, J., et al.[2022]

The study involving 379 college students showed that a smartphone app combined with Brief Motivational Interviewing (BMI) effectively reduced alcohol consumption and related consequences, particularly in voluntary participants.

In a controlled trial, participants using the app had a decrease in peak Blood Alcohol Concentration (BAC) compared to those receiving only in-person BMI, highlighting the app's potential as a beneficial tool for alcohol intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Theory-Based mHealth Intervention for High-Risk Drinking in College Students. Kazemi, DM., Borsari, B., Levine, MJ., et al.[2021]

A study involving 503 young adults aged 18-30 tested the effectiveness of the 'Boozebuster' mobile app against an educational website for reducing alcohol consumption, but found no significant differences in outcomes between the two groups.

Both the app and the website led to reductions in alcohol consumption, suggesting that motivation to change drinking behavior and engagement with the intervention were key factors influencing the results, rather than the specific intervention itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of a mobile intervention to reduce young adults' alcohol consumption to not exceed low-risk drinking guidelines. Schulte, MHJ., Boumparis, N., Kleiboer, A., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06281821?draw=2&rank=1

Mobile App-based Approach for Reducing Pain and ... The objectives of this study are to test the acceptability and feasibility of a smartphone-based intervention for reducing pain and alcohol use among ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12433316/

The Effectiveness of Mobile Health (mHealth) in Reducing ... This review analysed ten recent mHealth studies targeting alcohol reduction, with nine showing positive outcomes. Mobile applications proved ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871624000425

Mobile health intervention to address chronic pain among ... The purpose of this study was to develop a novel, integrated mobile health intervention that improves pain management and reduces hazardous drinking.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11056789/

Mobile Health Intervention to Address Chronic Pain Among ... The purpose of this study was to develop a novel, integrated mobile health intervention that improves pain management and reduces hazardous drinking.

5. withpower.com withpower.com/trial/phase-chronic-pain-1-2024-9e51f

Mobile App for Reducing Pain and Heavy Drinking Trial Overview The study is testing 'mhealth-pc', a mobile app-based approach, to see if it can help people with chronic pain reduce their hazardous drinking ...

6. cureus.com cureus.com/articles/397462-the-effectiveness-of-mobile-health-mhealth-in-reducing-alcohol-consumption-among-adults-in-developed-countries-a-systematic-review

The Effectiveness of Mobile Health (mHealth) in Reducing ... This review analysed ten recent mHealth studies targeting alcohol reduction, with nine showing positive outcomes. Mobile applications proved ...