Motivational Interviewing for Hearing Loss

(MI-HAT Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Prior hearing aid use, Non-English speakers, Inconsistent audiometry, Medical constraints, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how motivational interviewing, a counseling approach to encourage behavior change, can help people with hearing loss use their hearing aids more frequently. The goal is to determine if this approach can make users feel more comfortable and motivated to wear their hearing aids, thereby improving their quality of life. Participants will either receive standard hearing care or attend sessions focused on motivational interviewing in addition to their care. The trial seeks new hearing aid users who have difficulty hearing in one or both ears and can complete online questionnaires in English. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance hearing aid use and improve quality of life.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on hearing aid use and motivational interviewing, so it's unlikely that your medications would be affected.

What prior data suggests that motivational interviewing is safe for hearing loss patients?

Research has shown that motivational interviewing (MI) is generally safe for individuals. MI, a counseling method, encourages behavior change and has been extensively studied in healthcare and substance abuse treatment. Reviews of numerous studies indicate that MI positively impacts health behaviors without causing serious side effects.

In studies involving hearing aid users, no negative effects directly related to MI have been reported. While the effectiveness can vary, the method itself is well-tolerated. No major adverse events have been linked to MI in studies on hearing aid use or other health behaviors.

Overall, MI appears to be a safe way to help individuals make positive changes, such as increasing hearing aid use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using motivational interviewing for hearing loss because it offers a personalized approach that goes beyond standard audiological care. Unlike typical treatments that focus solely on hearing aids and devices, motivational interviewing involves one-on-one conversations that help patients address their ambivalence towards using these devices. This technique empowers individuals to take an active role in their hearing health, potentially leading to better adherence and more effective outcomes. By focusing on the psychological aspects of hearing loss treatment, motivational interviewing could significantly enhance the overall care experience.

What evidence suggests that motivational interviewing could be effective for hearing loss?

This trial will compare motivational interviewing (MI) with standard audiological care to evaluate its effectiveness in encouraging hearing aid use among new adult users. Research suggests that MI might help these users wear their devices more frequently. Some studies have found that one-on-one MI can promote hearing aid use, but results have been inconsistent. While one-on-one MI has shown promise, group MI sessions have primarily addressed issues like substance abuse, not hearing aid use. Overall, the evidence remains unclear, as early studies have shown both positive and negative outcomes. More research is needed to determine if MI can reliably enhance hearing aid use. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are new to using hearing aids and have a certain level of hearing loss in one or both ears. They must understand English as the motivational interviewing and questionnaires will be in this language. People with previous hearing aid experience, inconsistent hearing tests, or medical issues preventing hearing aid use cannot join.

Inclusion Criteria

Your hearing in the worse ear is not very good, with a hearing threshold above 25 decibels at certain frequencies.

You recently started using a hearing aid.

Exclusion Criteria

Have medical constraints that prohibit them from wearing hearing aids

Do not understand the English language

I cannot complete questionnaires in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the treatment group attend a 1-hour MI group session and receive standard audiological care. Control group receives standard care only.

12 months

Initial visit, and at 1, 3, 6, and 12-month time points

Follow-up

Participants are monitored for adherence to hearing aid use and effectiveness of motivational interviewing

12 months

Assessments at 1, 3, 6, and 12-month time points

What Are the Treatments Tested in This Trial?

Interventions

• Motivational Interviewing

Trial Overview The study is testing whether motivational interviewing (MI), a type of counseling that encourages behavior change, can increase the use of hearing aids among new users. It aims to address fears and shame associated with wearing aids by fostering motivation.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Treatment groups that undergo motivational interviewing with audiological care

Group II: Control Active Control 1 Intervention

Control groups that undergo standard audiological care

Motivational Interviewing is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Motivational Interviewing for:

• Substance Use Disorders
• Mental Health Conditions

Approved in European Union as Motivational Interviewing for:

• Addiction Treatment
• Behavioral Health Interventions

Approved in Canada as Motivational Interviewing for:

• Substance Abuse Treatment
• Mental Health Counseling

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

Motivational Interviewing (MI) is an effective, evidence-based method for helping caregivers support individuals in making health behavior changes by addressing their ambivalence.

The success of MI relies on creating a warm, empathetic environment that fosters patient self-efficacy and involves key techniques like expressing empathy and developing discrepancies in patient behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Motivational interviewing: some theoretical aspects and some practical exercises]. Gache, P., Fortini, C., Meynard, A., et al.[2007]

A workshop introducing motivational advising (MA) techniques to 48 medical educators was well-received, with over 80% expressing interest in further learning and over 60% wanting to implement MA with their advisees.

The workshop significantly increased participants' knowledge of MA, suggesting it is an effective tool for helping medical learners overcome challenges in their career development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational Advising Workshop: Utilizing Motivational Interviewing Theory to Facilitate and Engage Intrinsic Motivation to Change Learners' Behavior. Parekh, K., Benningfield, M., Burrows, H., et al.[2020]

Motivational interviewing (MI) has shown a strong short-term effectiveness in promoting readiness for change, with an average effect size of 0.77 across 72 clinical trials, although this effect diminishes to 0.30 at follow-ups up to one year.

The effectiveness of MI is notably higher among ethnic minority populations and when not strictly following a manual, indicating that flexibility in its application may enhance its impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing. Hettema, J., Steele, J., Miller, WR.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37217960/

study protocol for a randomized controlled trial This trial is designed to evaluate the efficacy of one-on-one MI in improving hearing aid use in new adult users in the short and long terms.

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07352-7

study protocol for a randomized controlled trial The aim of this study is to investigate the impact of one-on-one MI sessions on hearing aid use among new adult users.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34062605/

Motivational Interviewing for Hearing Aid Use: A Systematic ... The aim of the study is to conduct a meta-analysis examining the impact of motivational interviewing (MI) on hearing aid (HA) use compared with standard care.

4. psycnet.apa.org psycnet.apa.org/record/2022-40845-001

Motivational interviewing for hearing aid use: A systematic ... Purpose: The aim of the study is to conduct a meta-analysis examining the impact of motivational interviewing (MI) on hearing aid (HA) use compared with ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04673565/motivational-interviewing-in-hearing-aid-users?activelyRecruiting=false&page=60&id=846&slug=deafness

Motivational Interviewing in Hearing Aid Users Motivational interviewing (MI) is a counselling style aimed at creating desire in patients to change their behavior.

6. ctv.veeva.com ctv.veeva.com/study/motivational-interviewing-in-hearing-aid-users

Motivational Interviewing in Hearing Aid Users (MI-HAT) Motivational interviewing (MI) is a counselling style aimed at creating desire in patients to change their behavior.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10201034/

study protocol for a randomized controlled trial - PMC This trial is designed to evaluate the efficacy of one-on-one MI in improving hearing aid use in new adult users in the short and long terms.

8. stacks.cdc.gov stacks.cdc.gov/view/cdc/230016/cdc_230016_DS1.pdf

Effectiveness of Motivational Interviewing in Increasing Use ... The purpose of this pilot study was to determine the preliminary effectiveness of a telephone-based MI intervention in increasing hearing protection device use ...

9. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/21650799221139996

Effectiveness of Motivational Interviewing in Increasing Use ... There was a marginal increase in the use of hearing protection after the intervention, although setting-specific increases in use were uneven.

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8200683/

Motivational Interviewing: An Evidence-Based Approach for ... Meta-analyses reveal statistically significant mean intervention effects of MI in medical care with respect to a variety of health-relevant modes of behavior, ...