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

Trial Summary

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 data supports the effectiveness of the treatment Brief motivational interviewing with personalized feedback and Brief motivational interviewing with standard health information for liver disease?

Research shows that personalized feedback and encouragement, like those used in motivational interviewing, can help patients stay motivated and continue their treatment, as seen in a study where patients with liver disease successfully maintained their diet therapy with online support. ^{1 2 3 4 5}

Is Motivational Interviewing safe for use in humans?

Motivational Interviewing (MI) has been used safely in various settings, including with older adults and individuals undergoing methadone maintenance treatment, without any reported safety concerns. ^{6 7 8 9 10}

How does the treatment 'Brief motivational interviewing for liver disease' differ from other treatments for liver disease?

This treatment is unique because it uses motivational interviewing, a communication technique that helps patients explore their ambivalence and encourages them to change their health behaviors. Unlike traditional treatments that may focus solely on medical interventions, this approach involves personalized feedback and standard health information to motivate patients to take better care of their liver health. ^{8 11 12 13 14}

What is the purpose of this trial?

Liver damage from alcohol intake and weight-related behaviors is preventable and treatable only through lifestyle changes. This mixed-methods randomized controlled trial compares standard and enhanced approaches to screening, brief intervention, and referral to treatment/prevention (SBIRT/P) to identify and intervene for metabolism- and alcohol-associated liver disease (MetALD). Our multidisciplinary team aims to show that integrating results of noninvasive liver screening with Fibroscan®, a painless ultrasound that measures stiffness and fat in the liver, can optimize our brief intervention. The study population is adults age 21+ who speak Spanish or English from underresourced communities with alcohol- and weight-related risks for MetALD.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Lifestyle Intervention in NAFLD: Long-Term Diabetes Incidence in Subjects Treated by Web- and Group-Based Programs. [2023]

2. Japan pubmed.ncbi.nlm.nih.gov

A Customized Online Nutrition Guidance System Is Effective for Treating Patients with Nonalcoholic Fatty Liver Disease by Supporting Continuity of Diet Therapy at Home: A Pilot Study. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of health-related quality-of-life measurement in clinical practice: a prospective, randomized controlled trial in patients with chronic liver disease and their physicians. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Readiness for the epidemic: The adult nonalcoholic fatty liver disease toolkit for primary care nurse practitioners. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Randomized trial of an uncertainty self-management telephone intervention for patients awaiting liver transplant. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Initial efficacy of MI, TTM tailoring and HRI's with multiple behaviors for employee health promotion. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Effectiveness of intervention on improvement of drug use among methadone maintained adults. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Education and counseling in the methadone treatment setting improves knowledge of viral hepatitis. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Predictors of HAV/HBV vaccination completion among methadone maintenance clients. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Motivational interviewing for older adults in primary care: a systematic review. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Brief motivational interviewing for DWI recidivists who abuse alcohol and are not participating in DWI intervention: a randomized controlled trial. [2015]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Predictors of hepatitis knowledge improvement among methadone maintained clients enrolled in a hepatitis intervention program. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Motivating Behavioral Change. [2022]

14. France pubmed.ncbi.nlm.nih.gov

[Motivational interviewing use for promoting health behavior: an approach of doctor/patient relationship]. [2022]