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.
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)
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Tinnitus, Distress, Emotional, Depression, Anxiety, Sleep
- 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 group | Role | What they receive |
|---|---|---|
| Internet-delivered cognitive behavioral therapy for tinnitus | Experimental | An 8-week modular cognitive behavioral therapy Receives: Behavioral: Internet-delivered cognitive behavioral therapy (iCBT) |
| Internet-delivered mindfulness-based therapy for tinnitus | Experimental | An 8-week mindfulness-based stress reduction. Receives: Behavioral: Internet-delivered mindfulness-based tinnitus stress reduction (iMBTSR) |
| Waiting-list control | No intervention | The waiting list for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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.
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
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.
- First posted30 Jan 2023
- Study start15 Feb 2023
- Primary completion11 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonas Eimontas, Vilnius University
- Investigators
- Jonas Eimontas, PhD, Principal investigator, Vilnius University
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behavioral Therapy for Tinnitus Compared to an Internet-delivered Mindfulness Intervention
- ClinicalTrials.gov ID
- NCT05705323
- Acronym / sponsor ID
- TinnitusLT / TinnitusLT_1_2022
- Conditions
- Tinnitus, Distress, Emotional, Depression, Anxiety, Sleep
- Keywords
- CBT, Tinnitus, Mindfulness-based stress reduction, Internet-delivered, Cognitive behavioral therapy, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered cognitive behavioral therapy for tinnitus | Experimental | Behavioral: Internet-delivered cognitive behavioral therapy (iCBT)An 8-week modular cognitive behavioral therapy |
| Internet-delivered mindfulness-based therapy for tinnitus | Experimental | Behavioral: Internet-delivered mindfulness-based tinnitus stress reduction (iMBTSR)An 8-week mindfulness-based stress reduction. |
| Waiting-list control | No intervention | –The waiting list for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-delivered cognitive behavioral therapy (iCBT)This CBT is specifically adapted for individuals experiencing tinnitus | Behavioural | Internet-delivered cognitive behavioral therapy for tinnitus |
| Internet-delivered mindfulness-based tinnitus stress reduction (iMBTSR)This is a mindfulness-based intervention specifically adapted for individuals experiencing tinnitus | Behavioural | Internet-delivered mindfulness-based therapy for tinnitus |
Primary outcome
Change in score on Tinnitus Handicap Inventory (THI)
Time frame: Pre-treatment, week 8, 3 and 12 months post-treatment
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.
6 secondary outcomes
Change in score on Patient Health Questionnaire (PHQ-9)
Time frame: Pre-treatment, week 8, 3 and 12 months post-treatment
Change in score on Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Pre-treatment, week 8, 3 and 12 months post-treatment
Change in score on Insomnia Severity Index (ISI)
Time frame: Pre-treatment, week 8, 3 and 12 months post-treatment
Change in score on Tinnitus and Hearing Survey (THS)
Time frame: Pre-treatment and week 8.
Change in score on The Mindful Attention Awareness Scale (MAAS])
Time frame: Pre-treatment, week 8, 3 and 12 months post-treatment
Change in score on Tinnitus Cognitions Questionnaire (TCQ)
Time frame: Pre-treatment, week 8, 3 and 12 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Derived from this study: PubMed 37046290Eimontas 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas Eimontas, PhD principal investigator
Vilnius University
1 site in 1 country: see every site and its status.
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.