Guided ICBT for Tinnitus

Overseen By Frank Ocran, MSc.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Severe mental health, Cognitive impairments, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether online Cognitive Behavioural Therapy (CBT) can reduce distress from tinnitus (ringing in the ears) and improve related issues like anxiety, depression, and sleep problems. Participants will follow either a personalized CBT program or a standard one over eight weeks, with weekly guidance from a trained professional. The trial aims to determine if the personalized program is as effective as the standard one. Individuals who have experienced tinnitus for over six months and live in Canada might be suitable if they can access the internet and aren't receiving other regular therapy. As an unphased trial, this study offers a unique opportunity to contribute to understanding how online CBT can benefit those with tinnitus.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot participate if you are currently involved in another regular psychotherapeutic intervention or undergoing any tinnitus therapy.

What prior data suggests that guided Internet-delivered Cognitive Behavioural Therapy is safe for treating tinnitus-related distress?

Research has shown that guided Internet-delivered Cognitive Behavioural Therapy (ICBT) is generally safe and well-tolerated for managing the distress caused by tinnitus. Studies have found that ICBT effectively reduces distress from tinnitus, as well as related anxiety and depression. Participants in these studies did not report significant negative effects, indicating the therapy's safety.

In one study, many patients using an internet-based CBT system for tinnitus experienced a decrease in the impact of tinnitus on their lives. This suggests that the treatment is not only effective but also manageable for patients without major side effects. Another analysis found that internet-based CBT successfully reduced symptoms without major safety concerns.

Overall, guided ICBT appears to be a safe option for those seeking to reduce tinnitus-related distress and improve their quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Guided Internet-delivered Cognitive Behavioural Therapy (ICBT) for tinnitus because it offers a personalized approach that current standard treatments, such as sound therapy or in-person cognitive behavioral therapy, might not provide. The personalized ICBT allows participants to collaborate with a guide to tailor the 21-module program to fit their specific needs, ensuring a more targeted therapy experience. Additionally, both the personalized and standard ICBT groups receive weekly support through video chat or phone, making it a flexible and accessible treatment option. This digital and personalized method could make managing tinnitus more convenient and potentially more effective for individuals compared to traditional in-person therapies.

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

Research has shown that guided Internet-delivered Cognitive Behavioural Therapy (ICBT) effectively manages tinnitus. Studies have found that ICBT significantly reduces the severity and distress caused by tinnitus and has a strong impact. It also helps lower anxiety and depression levels related to tinnitus. One study found that ICBT reduced tinnitus distress more than just monitoring symptoms. This trial will compare two approaches: Personalized ICBT, where participants work with a Guide to tailor the program to their needs, and Standard ICBT, where participants receive the program as is. Both approaches offer structured support and tools to manage symptoms over time. Overall, ICBT is a promising approach for those dealing with tinnitus and its related issues. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-79 in Canada who have had tinnitus for over 6 months, can read and write English, are mentally able to consent and participate, have the needed tech (phone, computer, internet), and score at least 25 on the TFI indicating they need tinnitus care.

Inclusion Criteria

I can read and write in English.

I have access to a phone, computer, and internet.

I am a resident of Canada.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a personalized or standard ICBT program delivered over 8 weeks, consisting of 21 modules with guided support of 10-15 minutes per week by video chat or phone.

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment through online surveys at 3-month follow-up.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Guided Internet-delivered Cognitive Behavioural Therapy

Trial Overview The study tests if guided Internet-delivered Cognitive Behavioural Therapy helps with distress from tinnitus and related issues like anxiety or poor sleep. It compares a personalized ICBT program against a standard one over an 8-week course with weekly guide support.

How Is the Trial Designed?

Group I: Personalized ICBT Experimental Treatment 1 Intervention

Before initiation of the program, participants in the personalized ICBT group will collaboratively work with the Guide to determine which modules of the ICBT program best meet the participant's needs/goals. The ICBT program contains a total of 21 modules. Once modules have been selected, the Guide will develop a personalized program for the participant. The participant will then be enrolled into the personalized program. Participants in this group will receive guided support by video chat or phone each week (based on participant's preference) by a trained Guide over the 8-week duration of the program. Weekly contact will include motivating participants to complete the weekly lessons and assistance on the practicing/application of the skills. The Guide will spend approximately 10-15 minutes per week with each participant.

Group II: Standard ICBT Active Control 1 Intervention

Participants in the standard group will receive the ICBT program (containing 21 modules) as is. No personalization will be provided. Similar to the personalized ICBT group, participants will receive guided support by video chat or phone each week (based on participant's preference) by a trained Guide over the 8-week duration of the program. Weekly contact will include motivating participants to complete the weekly lessons and assistance on the practicing/application of the skills. The Guide will spend approximately 10-15 minutes per week with each participant.

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Published Research Related to This Trial

Internet-based cognitive behavioral therapy (ICBT) for tinnitus was successfully translated into Spanish, showing a large effect size (d = 0.90) in reducing tinnitus severity among 32 participants, indicating its potential effectiveness for Spanish speakers.

While the intervention was feasible, with no withdrawals, engagement and compliance were not optimal, suggesting the need for improvements in these areas and further research through a randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based cognitive behavioural therapy for tinnitus in Spanish: a global feasibility trial. Beukes, EW., Munzo, MF., Andersson, G., et al.[2022]

Citations

1. jmir.org jmir.org/2022/2/e27584/

Internet-Based Audiologist-Guided Cognitive Behavioral ... Results: Internet-based CBT led to a greater reduction in tinnitus distress (mean 36.57, SD 22) compared with that in weekly monitoring (mean ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9637888/

Long-term efficacy of audiologist-guided Internet-based ... Undertaking ICBT for tinnitus led to significant improvements 1-year post-intervention for tinnitus severity, with a large effect size (d = 1.06; CI: 0.80 to ...

3. pubs.asha.org pubs.asha.org/doi/10.1044/2022_AJA-21-00270

Predicting the Outcomes of Internet-Based Cognitive ... Internet-based cognitive behavioral therapy (ICBT) has been found to be effective for tinnitus management, although there is limited ...

4. frontiersin.org frontiersin.org/journals/audiology-and-otology/articles/10.3389/fauot.2023.1302215/full

Delivery of internet-based cognitive behavioral therapy ... Internet-based delivery of CBT is effective in decreasing tinnitus distress, and levels of anxiety and depression, which is more relevant today than ever.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6583080/

Effectiveness of Guided Internet-Based Cognitive ... This randomized noninferiority clinical trial compares the effectiveness of guided internet-based cognitive behavioral therapy vs face-to-face clinical care

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12109689/

Cognitive Behavioural Therapy (CBT) for Managing ... Following CBT, these numbers dropped substantially: 37.5% of patients still experienced tinnitus impact according to the TIQ (25% severe impact, 12.5% slight ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02438891

Treatment of Tinnitus Using a Web-based Sound and ... The purpose of this study is to evaluate a internet-based cognitive behavioral therapy (CBT) system as a method of treating patients with tinnitus. Tinnitus is ...

8. bmjopen.bmj.com bmjopen.bmj.com/content/11/8/e049384

secondary analysis to examine predictors of outcomes The current study examined predictors of outcomes of internet-based cognitive–behavioural therapy (ICBT) for individuals with tinnitus.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272735824001399

Do the effects of internet-delivered cognitive-behavioral ... The present study meta-analyzed the long-term efficacy of guided and self-guided i-CBTs on CMD outcomes. Data from 154 RCTs (N = 45,335) across 15 nations were ...