Tinnitus, SubjectiveNCT04382807
Internet-delivered Group Counseling for Chronic Tinnitus
An observational study of Tinnitus, Subjective, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
In the treatment of chronic tinnitus, psycho-education plays an import role to provide more insights into the symptoms of tinnitus. However, the need for e-health is increasing. As such, it is important to investigate if these psycho-education sessions can be delivered online, with the same efficacy compared to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Subjective
- What is being tested?
- Counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 12 May 2020to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Subjective, chronic tinnitus patients
Who may be able to join
- Patients with subjective, chronic tinnitus
Who cannot join
- Enrollment in other tinnitus treatments simultaneously at the time of the intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
In the treatment of chronic tinnitus, psycho-education plays an import role to provide more insights into the symptoms of tinnitus. However, the need for e-health is increasing. As such, it is important to investigate if these psycho-education sessions can be delivered online, with the same efficacy compared to the traditional face-to-face delivery.
- Conditions
- Tinnitus, Subjective
- Being tested
- Counseling
- Keywords
- tinnitus treatment, delivery method, psycho-educational counseling, internet-based
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounselingBehavioural
Online delivered group counseling session, providing insights into the tinnitus symptoms
| Study group | Role | What they receive |
|---|---|---|
| Subjective, chronic tinnitus | Tinnitus patients who received internet-based psycho-educational counseling Receives: Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tinnitus Functional Index (TFI)
Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus.
Measured: before intervention, 3 months follow-up
Secondary outcomes (3)
Change in Visual Analogue scale (VAS) for tinnitus loudness
Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus
Measured: before intervention, 3 months follow-up
Change in Hospital Anxiety and Depression Scale (HADS)
Self-report questionnaire concerning anxiety and depression symptoms, ranging from 0-21 for each subscale. A result greater than 8 suggests the presence of a depression and/or anxiety disorder.
Measured: before intervention, 3 months follow-up
Change in Hyperacusis Questionnaire (HQ)
Hyperacusis severity self-report questionnaire, ranging from 0-42 with a higher score representing a higher sensitivity to sounds. A score of 28 is the cut-off for auditory hypersensitivity.
Measured: before intervention, 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start12 May 2020
- Primary completion12 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinnitus, SubjectiveStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laure Jacquemin, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382807
- Sponsor's protocol ID
- 17/43/481
- Status last verified
- Apr 2026
- First submitted
- 5 May 2020
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Group Counseling for Chronic Tinnitus
- ClinicalTrials.gov ID
- NCT04382807
- Acronym / sponsor ID
- 17/43/481
- Conditions
- Tinnitus, Subjective
- Keywords
- tinnitus treatment, delivery method, psycho-educational counseling, internet-based
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 12 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 May 2020 (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.
In the treatment of chronic tinnitus, psycho-education plays an import role to provide more insights into the symptoms of tinnitus. However, the need for e-health is increasing. As such, it is important to investigate if these psycho-education sessions can be delivered online, with the same efficacy compared to the traditional face-to-face delivery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjective, chronic tinnitus | – | Behavioral: CounselingTinnitus patients who received internet-based psycho-educational counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjective, chronic tinnitus patients
Key inclusion criteria (1 listed)
- Patients with subjective, chronic tinnitus
Key exclusion criteria (1 listed)
- Enrollment in other tinnitus treatments simultaneously at the time of the intervention
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 |
|---|---|---|
| CounselingOnline delivered group counseling session, providing insights into the tinnitus symptoms | Behavioural | Subjective, chronic tinnitus |
Primary outcome
Change in Tinnitus Functional Index (TFI)
Time frame: before intervention, 3 months follow-up
Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus.
3 secondary outcomes
Change in Visual Analogue scale (VAS) for tinnitus loudness
Time frame: before intervention, 3 months follow-up
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: before intervention, 3 months follow-up
Change in Hyperacusis Questionnaire (HQ)
Time frame: before intervention, 3 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Tinnitus, Subjective
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
Not yet recruiting
Advanced Neurofeedback for Tinnitus
Tinnitus, Subjective
Not yet recruiting
Efficacy Analysis of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Tailor-Made Notched Music Therapy in the Treatment of Chronic Subjective Tinnitus
Chronic Subjective Tinnitus
Recruiting
Non-Invasive Neurofeedback Training to Alleviate Tinnitus Distress
Tinnitus Aggravated, Tinnitus
Not yet recruiting
COMPARISON OF MANUAL THERAPY, TINNITUS RETRAINING THERAPY
Somatosensory Tinnitus, Subjektif tınnitus
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus, Subjective, run by University Hospital, Antwerp at 1 site in Belgium.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 29 Apr 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
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 Tinnitus Functional Index (TFI) (time frame: before intervention, 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.