Motivational Interviewing for Liver Disease

Overseen By Primary Researcher

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brown University

Must not be taking: Alcohol use meds, Weight loss meds

Disqualifiers: Liver disease, Kidney failure, Pregnancy, others

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

Compensation: Varies

Number of Visits: 8

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to assist individuals with or at risk of liver issues caused by alcohol and weight. It uses motivational interviewing, a type of counseling, to promote healthier habits. One group will receive standard health advice, while the other will get personalized feedback based on liver health, assessed through a Fibroscan® (a painless ultrasound that checks liver stiffness and fat). Participants should be adults who drink more than recommended, have a BMI of 25 or higher, and can speak English or Spanish. As an unphased trial, this study provides a unique opportunity to contribute to understanding and improving liver health strategies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are newly taking medications for alcohol use, drug problems, or weight loss, you may not be eligible to participate.

What prior data suggests that this protocol is safe for participants?

Research shows that motivational interviewing (MI) with personalized feedback is generally well-received. Studies have found that personalized feedback in MI can improve liver function and support healthier lifestyle choices. This method has been applied in various contexts, such as managing alcohol use and other health behaviors, without significant negative effects reported.

Regarding liver health, personalized MI has been linked to better adherence to health advice and improved liver-related outcomes. Participants who received these interventions often demonstrated positive changes in their health habits, which can enhance liver health. Overall, research suggests that this treatment is safe and may effectively address liver issues related to alcohol and weight. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for liver disease because they use motivational interviewing, a psychological technique that helps people change their behaviors by focusing on their motivations. Unlike traditional treatments that might rely heavily on medication or medical procedures, these approaches focus on personal motivation and feedback. The enhanced version even provides personalized feedback by incorporating detailed information from liver imaging, so participants can see how their liver is affected by their behaviors. This personalized approach could be more engaging and potentially more effective in encouraging lifestyle changes needed to improve liver health.

What evidence suggests that this trial's treatments could be effective for liver disease?

This trial will compare two approaches to motivational interviewing for liver disease. Participants in the Enhanced Intervention arm will receive motivational interviewing that includes personalized feedback on self-reported alcohol intake and liver imaging scores. Studies have shown that motivational interviewing with personalized feedback can effectively reduce alcohol use. In one study, this approach helped heavy drinkers cut back by providing specific information about their drinking habits. Another study found that personalized feedback improved liver health by showing participants how their alcohol use affected liver function and scarring. This method combines motivational support with specific data from liver scans, offering a focused way to encourage healthier lifestyle choices. Overall, research supports using personalized feedback in motivational interviewing to help manage alcohol-related liver issues. Meanwhile, participants in the Standard Intervention arm will receive motivational interviewing with standard health information. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

Adults over 21 from underresourced communities at risk for metabolism- and alcohol-associated liver disease (MetALD) due to high alcohol intake or a BMI of 25 kg/m2 or higher. Participants must speak English or Spanish to understand the study and give informed consent.

Inclusion Criteria

Exceed alcohol intake screening guidelines for MetALD

Have a Body Mass Index (BMI) >=25 kg/m2

Be able to speak and read English or Spanish to provide written informed consent and understand written and oral instructions in English or Spanish

Exclusion Criteria

Pre-existing mental health conditions that, in the opinion of the investigative team, would interfere with the ability to provide informed consent and understand written and oral instructions (e.g., hepatic encephalopathy, psychotic disorder diagnosis or symptoms)

Current pregnancy

Anyone who, based on self-reported withdrawal symptoms and the opinion of the investigative team, could not currently safely be withdrawn from alcohol without medical detoxification

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Participants undergo baseline assessments including satisfaction with Fibroscan® liver imaging

1 week

1 visit (in-person)

Intervention

Participants receive psychotherapy utilizing motivational interviewing with either standard or enhanced health information

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for changes in alcohol intake and weight-related risks

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Brief motivational interviewing with personalized feedback
• Brief motivational interviewing with standard health information

Trial Overview The trial is testing two types of brief motivational interviewing: one with personalized feedback, another with standard health information. The goal is to see which method better helps people change their lifestyle to prevent or treat liver damage caused by alcohol and weight-related behaviors.

How Is the Trial Designed?

Group I: Enhanced Intervention Experimental Treatment 1 Intervention

Participants randomly assigned to this arm will receive psychotherapy utilizing manualized principles of motivational interviewing that incorporates personalized feedback on self-reported alcohol intake and two scores from Fibroscan® liver imaging that indicate steatosis (liver fat) and fibrosis (liver scaring).

Group II: Standard Intervention Active Control 1 Intervention

Participants randomly assigned to this arm will receive psychotherapy utilizing manualized principles of motivational interviewing with standard health information.

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Published Research Related to This Trial

Motivational interviewing (MI) is an effective communication technique that helps patients engage in discussions about changing their health behaviors by addressing their ambivalence.

MI practitioners use specific skills and strategies to create a gap between a patient's current behaviors and their personal goals, facilitating a more productive conversation about health changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivating Behavioral Change. Tooley, EM., Kolahi, A.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6061969/

Motivational Interviewing with Personalized Feedback to ... This randomized controlled trial tested the efficacy of motivational interviewing (MI) to reduce alcohol use among heavy drinking men who have sex with men ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05135767

Biobehavioral Pathways Underlying Alcohol Use and Health Behavioral : Brief Motivational Interviewing with Personalized Feedback. A brief motivational interviewing (MI) intervention will target drinking. The ...

3. withpower.com withpower.com/trial/phase-liver-diseases-3-2025-44ac8

Motivational Interviewing for Liver Disease Trial Overview The trial is testing two types of brief motivational interviewing: one with personalized feedback, another with standard health information. The ...

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/20552076241242787

Multiplatform web app (My Way Up) plus motivational ... The current study details the development and usability assessment of an intervention combining a brief motivational intervention with the use ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/am-pdf/10.1111/add.15263

Brief Alcohol Intervention in Liver Disease 1 Participants with HCV also received personalized feedback on the effects of alcohol use on their viral load, liver functioning, and antiviral treatment ...

6. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-18865-4

BRIDGE to liver health: implementation of a group telehealth ... Group-based interventions that employ motivational interviewing (MI) and provide personalized information with feedback on specific dietary ...