Senyo App for Addiction

Enrolling by invitation at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Personality pathology, Severe cognitive impairment, Psychosis, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal use of a digital app, the Senyo App, to assist individuals with substance use disorder (issues related to drug or alcohol use) in accessing necessary care. Participants will either begin using the app immediately or after a 12-week delay. The study aims to identify factors that help or hinder the app's use in primary care settings. Suitable candidates have access to a smartphone and are willing to collaborate with a primary care doctor at a Mayo Clinic site. This trial may be appropriate for those who have experienced challenges with drugs or alcohol and wish to explore digital support options. As an unphased trial, it offers a unique opportunity to contribute to innovative digital health solutions for substance use disorder.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Senyo App is safe for use in addiction treatment?

Research has shown that digital tools like the Senyo App can safely help treat substance use disorder (SUD). In other studies on digital tools for SUD, participants have generally used these apps without problems, and reports of serious side effects have been rare. This is promising for those considering joining a trial with the Senyo App.

While specific safety data for the Senyo App itself is not yet available, its inclusion in a trial indicates it has been deemed safe enough for testing with people. Digital health tools often pose fewer risks than treatments involving medication, as they do not require taking or injecting substances.

In summary, the Senyo App is expected to be well-tolerated based on the safety of similar digital treatments. Participants can feel reassured by the existing data on digital tools for SUD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Senyo App for addiction because it offers a novel, digital approach to manage addiction. Unlike traditional treatments like medication-assisted therapy or in-person counseling, the Senyo App provides immediate access to support and intervention tools right on a user's smartphone. This means it can offer real-time assistance and potentially reach a wider audience, especially those who might not have access to conventional treatment settings. Additionally, the app's ability to seamlessly integrate into daily life could enhance adherence and engagement, making it a promising tool in the fight against addiction.

What evidence suggests that the Senyo App is effective for Substance Use Disorder?

Research has shown that the Senyo App, available to participants in this trial, might aid in treating Substance Use Disorder (SUD). Early results suggest that users of the app improve more than those in the waitlist control group, who will receive the intervention after 12 weeks. The app employs a method called SBIRT, which stands for Screening, Brief Intervention, and Referral to Treatment. This method helps identify and address substance use problems early. Although exact success rates are not available, the app aims to facilitate access to necessary help. ^{2 3 4 5 6}

Who Is on the Research Team?

Tyler Oesterle

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with Substance Use Disorder (SUD) who are patients at Mayo primary care clinics. The study aims to understand how a digital tool can help in their treatment.

Inclusion Criteria

Ability to read, write, and understand English

Minimum DAST score of 1+ and audit-C score of 3+

Access and willingness to use a mobile device for asynchronous (text) and synchronous (video) engagement with care

Exclusion Criteria

I choose not to answer questions about thoughts of harming myself.

Diagnosed personality pathology as the primary presenting concern based on clinical judgment, severe cognitive impairment (e.g., intellectual disability or dementia), or psychosis

Inability to actively participate in and learn from psychotherapeutic interaction based on clinical evaluation and clinical judgment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Waitlist

Subjects randomized to the waitlist group will serve as a control group and receive intervention after 12 weeks on the waitlist

12 weeks

Intervention

Subjects randomized to the Senyo group will begin receiving intervention immediately

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Senyo App

Trial Overview The trial is testing the 'Senyo App' against a waitlist control group, assessing its effectiveness in enhancing SUD treatment through screening and referrals within primary care settings.

How Is the Trial Designed?

Group I: Senyo Experimental Treatment 2 Interventions

Subjects randomized to the Senyo group will begin receiving intervention immediately, and will move to the follow-up phase after 12 weeks.

Group II: Waitlist Active Control 2 Interventions

Subjects randomized to the waitlist group will serve as a control group and receive intervention after 12 weeks on the waitlist.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

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]

Mobile phone applications, when used alongside standard addiction treatments, can enhance the effectiveness of these treatments by providing tools for information, monitoring, motivation, and relapse prevention.

Most studies reviewed indicated that patients using these applications experienced a greater reduction in substance consumption compared to those receiving standard treatment alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Mobile phone applications for addiction treatment]. Penzenstadler, L., Thorens, G., Bachmann, S.[2022]

The Internet can significantly enhance addiction treatment by enabling efficient delivery of educational content and secure collection of self-reported data on substance use, making treatment more accessible and effective.

Internet applications support various aspects of addiction treatment, including assessment, monitoring patient outcomes, ongoing recovery support, and training for treatment providers, ultimately improving the quality of care and patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Internet technology can improve the quality of care for substance use disorders. Cucciare, MA., Weingardt, KR., Humphreys, K.[2019]

The qualitative study involving 20 users of the SURE Recovery app revealed that first impressions, such as trust and personal recommendations, significantly influence the app's uptake among individuals seeking support for substance use issues.

User engagement with the app improved when it provided positive feelings and relevant content, highlighting the importance of incorporating end-user feedback into app design to enhance its effectiveness in addiction recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons for Uptake and Engagement of a Smartphone App (SURE Recovery) for People in Recovery From Alcohol and Other Drug Problems: Interview Study of App Users. Neale, J., Bowen, AM.[2022]

The SIDEAL mobile app was well-accepted by 24 adult patients with alcohol dependence, showing high usage rates (80% of study days) and high satisfaction levels, particularly with its self-register and feedback features.

Participants experienced significant reductions in alcohol consumption over 6 weeks, with binge drinking days decreasing from an average of 25 to 5.8 and mean daily consumption dropping from 6.5 to 1.9 standard units, indicating the app's potential efficacy in managing alcohol dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management and Shared Decision-Making in Alcohol Dependence via a Mobile App: a Pilot Study. Barrio, P., Ortega, L., López, H., et al.[2018]

Out of 651 smartphone apps analyzed for smoking cessation, only 15 were focused specifically on this goal, with a majority categorized as calendars or information tools.

The evaluated apps showed a low adherence to established smoking cessation guidelines, with a mean score of only 12.8, indicating a need for improvement and the development of future apps based on evidence-based practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of smartphone apps for smoking cessation available in Portuguese. Formagini, TD., Ervilha, RR., Machado, NM., et al.[2018]

The study aims to evaluate the effectiveness of the 'CureApp Smoking Cessation' (CASC) app in improving smoking cessation rates among individuals with nicotine dependence, alongside a standard 12-week treatment program, with a total of 580 participants expected to be recruited.

CASC is designed to enhance treatment outcomes by providing personalized support through video tutorials, AI advice, and CO monitoring, and the primary outcome will be the continuous abstinence rate from weeks 9-24, which is anticipated to be significantly higher than that of a control app.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Smoking Cessation Smartphone App Integrated With a Mobile Carbon Monoxide Checker for Smoking Cessation Treatment: Protocol for a Randomized Controlled Trial. Nomura, A., Tateno, H., Masaki, K., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11982759/

Treatment of Substance Use Disorders With a Mobile ... A randomized controlled trial will occur where 30 participants are randomly assigned to immediately start the Senyo intervention compared to a waitlist control ...

2. researchprotocols.org researchprotocols.org/2025/1/e65693

Treatment of Substance Use Disorders With a Mobile ... A randomized controlled trial will occur where 30 participants are randomly assigned to immediately start the Senyo intervention compared to a ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06743282

Senyo Health With Substance Use Disorder (SUD) in ... These trials gather additional information about a drug's safety, efficacy, or optimal use. Phase Not Applicable. Describes trials without FDA-defined phases ...

4. jmir.org jmir.org/2018/1/e37/

Implementing a Mobile Health System to Integrate the ... Results: The outcomes according to the RE-AIM framework are as follows: Reach—Seva reached 8.31% (268/3226) of appropriate patients. Reach was ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40138685/

Protocol for a Mixed Methods Randomized Controlled Trial This protocol describes a novel use of the SBIRT pathway using Senyo Health to complement existing CoCM integration within primary care to deliver SUD ...

6. samhsa.gov samhsa.gov/

Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.