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TinnitusTinnitusLTNCT05705323

Internet-delivered Psychological Interventions for Tinnitus

A study testing Internet-delivered cognitive behavioral therapy (iCBT) and Internet-delivered mindfulness-based tinnitus stress reduction (iMBTSR) in people with Tinnitus and Distress, Emotional, run by Vilnius University at 1 site in Lithuania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tinnitus, Distress, Emotional, Depression, Anxiety
What is being tested?
Internet-delivered cognitive behavioral therapy (iCBT) and Internet-delivered mindfulness-based tinnitus stress reduction (iMBTSR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteLithuania
Study dates
15 Feb 2023to 1 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Lithuania1 site
  • Vilnius University

    Vilnius, Lithuania, LT-01513

Other trials in Lithuania

About this study

Official title: Internet-delivered Cognitive Behavioral Therapy for Tinnitus Compared to an Internet-delivered Mindfulness Intervention

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:

Read more
  • 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.

Being tested
Internet-delivered cognitive behavioral therapy (iCBT), Internet-delivered mindfulness-based tinnitus stress reduction (iMBTSR)
Keywords
CBT, Tinnitus, Mindfulness-based stress reduction, Internet-delivered, Cognitive behavioral therapy, Mindfulness
Medical subject headings
Tinnitus, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet-delivered cognitive behavioral therapy (iCBT)Behavioural

    This CBT is specifically adapted for individuals experiencing tinnitus

  • Internet-delivered mindfulness-based tinnitus stress reduction (iMBTSR)Behavioural

    This is a mindfulness-based intervention specifically adapted for individuals experiencing tinnitus

Study groups in NCT05705323
Study groupRoleWhat they receive
Internet-delivered cognitive behavioral therapy for tinnitusExperimentalAn 8-week modular cognitive behavioral therapy
Receives: Behavioral: Internet-delivered cognitive behavioral therapy (iCBT)
Internet-delivered mindfulness-based therapy for tinnitusExperimentalAn 8-week mindfulness-based stress reduction.
Receives: Behavioral: Internet-delivered mindfulness-based tinnitus stress reduction (iMBTSR)
Waiting-list controlNo interventionThe waiting list for 8 weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in score on Tinnitus Handicap Inventory (THI)

    The Tinnitus Handicap Inventory is designed to measure the subject's sensations caused by tinnitus and to assess the impact of tinnitus on daily life. It is also suitable for measuring the change in the severity of a murmur before and after an intervention. The THI questionnaire consists of 25 questions. The subject completes the questionnaire by ticking the most appropriate answer. The researcher scores the questionnaire as follows: 'Yes' is scored with 4 points, 'No' is scored with 0 points and 'Sometimes' is scored with 2 points. The total score is obtained by summing the number of responses to all 25 questions, multiplied by the coefficients given in the table. The higher the scale estimates, the higher the score, the more significant the disability caused by the murmur and the more significantly it affects the life of the subject. The severity scale is as follows: 0-16 mild; 18-36 moderate; 38-56 moderate; 58-76 severe; 78-100 catastrophic.

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

Secondary outcomes (6)
  1. Change in score on Patient Health Questionnaire (PHQ-9)

    Change from baseline in depression symptoms post-treatment (week 8), at three months, at 12 months and at 24 months post-treatment. Measure contains 9 questions that have to be responded to by choosing an answer from a 4-item Likert scale, where number 0 indicates 'Not at all' and 3 - 'Nearly every day'. Higher score indicates more severe symptoms.

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

  2. Change in score on Generalized Anxiety Disorder-7 (GAD-7)

    Change from baseline in anxiety symptoms post-treatment (week 8), at three months, at 12 months and at 24 months post-treatment. Measure contains 7 questions that have to be responded to by choosing an answer from a 4-item Likert scale, where number 0 indicates 'Not at all' and 3 - 'Nearly every day'. Higher score indicates more severe symptoms.

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

  3. Change in score on Insomnia Severity Index (ISI)

    The Insomnia Severity Index (ISI) (Bastien et al, 2001) measures insomnia symptomatology. The questionnaire consists of 7 questions with five optional ratings on a scale of 0 ('0' = not at all) to 4 ('4' = very much), with a time interval of 'within the last 2 weeks'. The scores for all 7 questions are aggregated and can be scored between 0 and 28 points. The number of points can be used to determine the severity of the insomnia: no insomnia (0 - 7); possible insomnia (8 - 14); moderate insomnia (15 - 21); severe insomnia (22 - 28).

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

  4. Change in score on Tinnitus and Hearing Survey (THS)

    The Tinnitus and Hearing Survey (Henry et al., 2015) is designed to differentiate hearing problems from tinnitus and consists of 3 subscales. Subscale A contains items that describe common tinnitus problems unrelated to hearing problems. Items in subscale B describe normal hearing problems that would not be caused by tinnitus. Subscale C contains 2 items that identify sound tolerance problems (hyperacusis) that may interfere with participation in the programme. Answers on subscales A and B can range from 0 (not a problem) to 4 (very big problem). Hence, the total scores for these subscales can range from 0 to 16. The items in each subscale begin with the phrase "In the last week..." in order for respondents to rate their current experience of tinnitus, rather than their past history when their tinnitus was most severe.

    Measured: Pre-treatment and week 8.

  5. Change in score on The Mindful Attention Awareness Scale (MAAS])

    The Mindful Attention Awareness Scale (MAAS]) (Brown \& Ryan, 2003) measures how often an individual experiences a state of mindful awareness. The scale consists of 15 statements. The statements cover cognitive, emotional, physiological, interpersonal, and general life domains. Each statement is rated on a 6-point Likert scale (1 = Almost always; 6 = Almost never). Higher scores indicate a tendency to experience a more frequent state of mindful awareness. For the overall score, the scores for all statements are added together, and an average score is calculated. Either the total score or the arithmetic mean of all the estimates is reported. There is no norm, but a higher sum of scores indicates a tendency to experience a more frequent state of attentive awareness.

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

  6. Change in score on Tinnitus Cognitions Questionnaire (TCQ)

    Tinnitus Cognitions Questionnaire (Wilson \& Henry, 1998). It is designed to assess a person's cognitions related to tinnitus/recognise cognitive reactions related to tinnitus. The questionnaire consists of 26 questions: 13 questions related to negative thoughts and 13 questions related to positive thoughts. For each item, participants are asked to indicate how often the person had a particular thought when the tinnitus symptoms occurred. Each statement is scored on a 5-point scale from 0 to 4 (0 for 'never', 1 for 'rarely', 2 for 'occasionally', 3 for 'often' and 4 for 'very often'). Negative items are scored from 0-4 and positive items from 4-0. The total score for this scale can range from 0 to 104. A high score on the scale indicates a greater tendency to engage in negative cognitions in response to tinnitus than positive ones.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2023
  2. Study start15 Feb 2023
  3. Primary completion11 Apr 2024
  4. Study completion1 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05705323
Sponsor's protocol ID
TinnitusLT_1_2022
Acronym
TinnitusLT
Status last verified
Sep 2025
First submitted
13 Jan 2023
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Eimontas J, Gegieckaite G, Asaciova I, Sticinskaite N, Arcimaviciute L, Savickaite D, Vaitiekunaite-Zubriakoviene D, Polianskis M, Gans J, Beukes E, Manchaiah V, Andersson G, Lesinskas E. Internet-delivered cognitive behavioral therapy for tinnitus compared to Internet-delivered mindfulness for tinnitus: a study protocol of a randomized controlled trial. Trials. 2023 Apr 12;24(1):269. doi: 10.1186/s13063-023-07299-9.

    PubMed 37046290

Questions about this trial

What is this clinical trial studying?

A study testing Internet-delivered cognitive behavioral therapy (iCBT) and Internet-delivered mindfulness-based tinnitus stress reduction (iMBTSR) in people with Tinnitus and Distress, Emotional, run by Vilnius University at 1 site in Lithuania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in score on Tinnitus Handicap Inventory (THI) (time frame: Pre-treatment, week 8, 3 and 12 months post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05705323, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.

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