ClinicalTrials.gg
Enrolling by invitationNCT04382807Updated Apr 29, 2026

Internet-delivered Group Counseling for Chronic Tinnitus

An observational study in Tinnitus, Subjective, sponsored by University Hospital, Antwerp. Enrolling by invitation at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by University Hospital, Antwerp · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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 traditional face-to-face delivery.

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Conditions studied

  • Tinnitus, Subjective

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Keywords

  • tinnitus treatment
  • delivery method
  • psycho-educational counseling
  • internet-based
03

In context

Tinnitus

444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.

This study's planned enrollment of 150 is above the median of 100 across 57 observational studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Subjective, chronic tinnitus patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with subjective, chronic tinnitus

Exclusion criteria

Exclusion Criteria:

  • Enrollment in other tinnitus treatments simultaneously at the time of the intervention
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Subjective, chronic tinnitus

    Tinnitus patients who received internet-based psycho-educational counseling

    Behavioral: Counseling

Interventions

  • BehavioralCounseling

    Online delivered group counseling session, providing insights into the tinnitus symptoms

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What researchers measure

Primary outcomes

  1. Change in Tinnitus Functional Index (TFI)

    Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus.

    Time frame: before intervention, 3 months follow-up

Secondary outcomes

  1. 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

    Time frame: before intervention, 3 months follow-up

  2. 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.

    Time frame: before intervention, 3 months follow-up

  3. 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.

    Time frame: before intervention, 3 months follow-up

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2020 (actual). Primary completion is estimated for Dec 2027, 91 months after the start.

Of 20 observational studies under Tinnitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 78. This study's planned 91 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
May 5, 2020
First posted
May 11, 2020
StartActual
May 12, 2020
Primary completionEst.
Dec 12, 2027
CompletionEst.
Dec 31, 2027
Last update
Apr 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04382807
Responsible party
Laure Jacquemin (Principal Investigator, University Hospital, Antwerp) — Principal investigator
First posted
May 11, 2020
Start date
May 12, 2020
Primary completion
Dec 12, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Apr 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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