Telemedicine-Based Therapy for Substance Abuse

Overseen By Linda Mobley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Acute psychosis, Cognitive deficits, Others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new telehealth program called MI-CBT Teletx, which combines motivational interviewing and cognitive behavioral therapy to assist individuals with substance use disorders. The goal is to make these programs more user-friendly and effective for those not currently receiving care. Ideal candidates have used substances like alcohol or drugs about twice a week in the past month and have access to a smartphone or similar device. Participants will join online sessions and complete surveys to provide feedback on the program. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve access to care for substance use disorders.

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 seems focused on therapy and does not mention medication changes.

What prior data suggests that this telemedicine-based therapy is safe for substance abuse treatment?

Research has shown that telemedicine, including online therapy like cognitive-behavioral therapy (CBT), effectively and safely treats substance use problems. Studies on similar programs suggest that combining motivational interviewing and CBT, as in the MI-CBT Teletx program, is generally well-received. Most participants do not experience serious side effects, and any discomfort is usually mild, such as temporary anxiety or frustration.

The treatment includes up to eight sessions by phone or video call, which many find convenient and less intimidating than in-person visits. This method has been tested in other groups and settings, with no major safety concerns reported. Overall, MI-CBT Teletx appears to be a safe option for those looking to improve their substance use outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about MI-CBT Teletx for substance abuse because it delivers therapy through telehealth, making it accessible to people who might not attend in-person sessions. Traditional treatments often involve face-to-face therapy, which can be a barrier for those with busy schedules or limited access to care facilities. MI-CBT Teletx combines cognitive behavioral therapy and motivational interviewing in a flexible format, using phone or video calls. This approach not only reaches more people but also adapts evidence-based therapies to fit modern lifestyles, potentially enhancing engagement and effectiveness.

What evidence suggests that MI-CBT Teletx might be an effective treatment for substance abuse?

Research has shown that telemedicine, including online therapy, effectively treats substance use problems. In this trial, participants will receive MI-CBT Teletx, which combines motivational interviewing (a type of counseling) with cognitive-behavioral therapy (CBT) to enhance outcomes for individuals with substance use issues. This telehealth method keeps people engaged in their treatment through phone or video sessions, increasing accessibility. Early evidence suggests this approach could support those not currently receiving treatment for substance use problems. ^{1 2 3 4 6}

Who Is on the Research Team?

Allison Lin, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals who have used substances on average twice a week over the past month, have been outpatient at Michigan Medicine in the last year, and own a device like a smartphone with internet. People can't join if they can't consent (like having acute psychosis), had severe alcohol withdrawal before, or don't speak English.

Inclusion Criteria

You have been diagnosed with a substance use disorder according to the DSM-5, or you have been using substances on average two days per week for the past month.

I have received outpatient care at Michigan Medicine in the last year.

Have a Smart phone, tablet or another Wi-Fi or data-enabled device (e.g. with a camera)

Exclusion Criteria

You cannot speak or understand English.

I am mentally capable of understanding and consenting to participate.

Prior alcohol withdrawal seizures or delirium tremens (DTs). Those who are at-risk of complicated withdrawal (e.g., seizures, DTs) require greater medical attention and will be excluded and referred to their clinician for medical management.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 8 psychosocial sessions delivered via telehealth, including motivational interviewing and cognitive behavioral therapy

8 weeks

Sessions delivered via phone or videoconference

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surveys and assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MI-CBT Teletx

Trial Overview The study tests motivational interviewing and psychosocial interventions delivered through telehealth to help patients with Substance Use Disorder (SUD). It aims to refine these programs for better feasibility and acceptability among 50 participants.

How Is the Trial Designed?

Group I: Teletx Experimental Treatment 1 Intervention

The evidence-based manualized psychosocial programs that will be delivered via telehealth are adaptations of cognitive behavioral therapy, motivational interviewing, and other psychosocial interventions to enhance initial and ongoing treatment engagement. TeleTx consists of up to 8 \~30-50 minute psychosocial sessions delivered via phone or videoconference platform (e.g. Zoom etc).

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

A pilot study involving 127 rural alcohol users showed that participating in 3 or more sessions of motivational enhancement therapy via telemedicine significantly reduced the likelihood of any alcohol use by 72%.

While there were no overall differences between groups, those who engaged in more sessions reported fewer days of drinking, fewer drinks per week, and fewer days with alcohol-related problems, suggesting that telemedicine can effectively reach at-risk populations who may not seek traditional treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

METelemedicine: a pilot study with rural alcohol users on community supervision. Staton-Tindall, M., Havens, JR., Webster, JM., et al.[2021]

CBT4CBT, a computer-based cognitive-behavioral therapy, was found to be a safe and effective stand-alone treatment for individuals with substance use disorders, showing significant reductions in substance use compared to standard treatment after six months.

Participants using CBT4CBT reported higher satisfaction and better understanding of cognitive and behavioral concepts than those receiving traditional clinician-delivered CBT, which had a higher dropout rate and less effectiveness at follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Clinical Trial of Computerized and Clinician-Delivered CBT in Comparison With Standard Outpatient Treatment for Substance Use Disorders: Primary Within-Treatment and Follow-Up Outcomes. Kiluk, BD., Nich, C., Buck, MB., et al.[2019]

Telemedicine, specifically through videoconferencing, is being used to effectively deliver motivational enhancement therapy to at-risk alcohol users in rural areas, where access to treatment is often limited.

This approach not only addresses the lack of evidence-based substance abuse treatment in rural communities but also tailors interventions to the specific needs of at-risk groups, enhancing the potential for positive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine-based alcohol services for rural offenders. Staton-Tindall, M., Wahler, E., Webster, JM., et al.[2021]

A survey of 363 substance use disorder organizations in the U.S. revealed that 50% showed high interest in telemedicine applications, particularly in computerized screenings and telephone-based supports, indicating a strong potential for integrating technology in treatment.

There is a significant gap between interest and actual use of certain telemedicine tools, such as texting appointment reminders and mobile apps for recovery, suggesting opportunities for further development and implementation in substance use disorder treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Telemedicine in Addiction Treatment: Current Practices and Organizational Implementation Characteristics. Molfenter, T., Brown, R., O'Neill, A., et al.[2020]

An 8-week all-virtual program for treating methamphetamine use disorder (MUD) was effective, with participants showing increased likelihood of testing negative for meth use over the course of the treatment (OR = 1.57).

The program, which included counseling, therapeutic tasks, and medical oversight, was well-received, with 55% of participants completing it and 16 out of 27 reporting no meth use one month after finishing the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demonstration of an app-delivered digital therapeutic program for methamphetamine use disorder. Muhlner, K., DeFlavio, J., Ang, A., et al.[2023]

A combination of motivational enhancement therapy (MET), cognitive-behavioral therapy (CBT), and contingency management (CM) is effective for treating cannabis use disorders, and a computer-assisted version of this treatment shows promise in overcoming barriers to access.

In a 12-week study with 38 adults, both therapist-delivered and computer-delivered treatments resulted in similar attendance and cannabis use outcomes, indicating that computer-assisted therapy is a viable alternative that maintains treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An initial trial of a computerized behavioral intervention for cannabis use disorder. Budney, AJ., Fearer, S., Walker, DD., et al.[2021]

In a randomized clinical trial with 101 cocaine-dependent individuals on methadone, those who had access to computer-based cognitive-behavioral therapy (CBT4CBT) were significantly more likely to achieve 3 or more consecutive weeks of abstinence from cocaine (36% vs. 17%).

The study demonstrated that CBT4CBT not only improved immediate treatment outcomes but also showed durable effects, with continued improvement observed 6 months after treatment, highlighting its potential as an effective and easily disseminable adjunct to traditional addiction treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-assisted delivery of cognitive-behavioral therapy: efficacy and durability of CBT4CBT among cocaine-dependent individuals maintained on methadone. Carroll, KM., Kiluk, BD., Nich, C., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04768920

Study Details | NCT04768920 | Examining Feasibility and ... The objective of this pilot intervention study is to iteratively refine motivational interviewing and psychosocial intervention programs delivered via ...

2. withpower.com withpower.com/trial/phase-substance-related-disorders-2-2021-dc6fa

Telemedicine-Based Therapy for Substance Abuse Research shows that telemedicine, including computer-based cognitive-behavioral therapy (CBT), is effective in treating substance use disorders. Studies have ...

3. reporter.nih.gov reporter.nih.gov/project-details/11103167

Project Details - NIH RePORTER Therefore, the objective of this study is to evaluate a telemedicine-delivered MI-CBT treatment intervention for AUD (MI-CBT TeleTx) compared to Enhanced Usual ...

4. mecp.springeropen.com mecp.springeropen.com/articles/10.1186/s43045-023-00377-3

Integrated MI & CBT for Egyptian Substance Use Disorder The authors aimed to evaluate the outcome of combined motivational interviewing and cognitive-behavioral therapy (MICBT) for substance use disorder

5. library.samhsa.gov library.samhsa.gov/sites/default/files/pep21-06-02-001.pdf

Telehealth for the Treatment of Serious Mental Illness and ... Telehealth for the Treatment of Serious Mental Illness and Substance Use Disorders. What Research Tells Us. 21. Cognitive Behavioral Therapy (CBT) via ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04817176

MI-CBT Adherence Program for Lifestyle Interventions in ... The program is a 6-week group, telehealth intervention for older adults with possible MCI. The intervention uses Motivational interviewing and cognitive ...