CompletedNot Applicable

Internet-delivered Psychological Interventions for Tinnitus

Lithuania67 participantsStarted 2023-02-15

Plain-language summary

Tinnitus can be very distressing for some individuals who experience it. The most studied intervention that works well for tinnitus distress is cognitive behavioral therapy (CBT). There is enough evidence to claim that internet-delivered guided CBT for tinnitus is as effective as CBT delivered face-to-face. The goal of this randomized controlled trial is to test the effectiveness of an internet-delivered cognitive behavioral therapy (CBT) for tinnitus and an internet-delivered mindfulness-based tinnitus stress reduction intervention by comparing them one against each other and a waiting list control group in the adult population experiencing tinnitus. The main questions this study aims to answer are: * Feasibility of delivering interventions for tinnitus distress over the internet. * Is any of the two interventions more effective in reducing tinnitus-related stress than the waiting list control? * Is the effectiveness of mindfulness intervention non-inferior to CBT intervention for tinnitus? * Is participant engagement and dropout different in mindfulness and CBT interventions? Participants will be randomly assigned to a CBT, Mindfulness, or control group and will be asked to engage with the materials prescribed to that group for eight weeks.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Experience tinnitus for at least three months; * Scores 28 or more on THI; * Has the ability to use a computer (or smartphone or tablet) with a connection to the internet for the duration of the study; * Comprehension and ability to write and speak in the Lithuanian language. Exclusion Criteria: * Inability to allocate sufficient time for participation in an 8-week intervention; * Significant medical or psychiatric conditions which would prevent participation; * Participation in other tinnitus interventions during the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in score on Tinnitus Handicap Inventory (THI)

Timeframe: Pre-treatment, week 8, 3 and 12 months post-treatment

Trial details

NCT IDNCT05705323

SponsorVilnius University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-11

View on ClinicalTrials.gov More Tinnitus trials