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Enrolling by invitation NCT04382807

Internet-delivered Group Counseling for Chronic Tinnitus

— Observational Tinnitus, Subjective

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Counseling.
Who it may be relevant to
Registry conditions: Tinnitus, Subjective. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Change in Tinnitus Functional Index (TFI) [Time frame: before intervention, 3 months follow-up]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

Inclusion criteria

  • Patients with subjective, chronic tinnitus

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

Belgium · 1 center
  • University Hospital Antwerp — Antwerp

Identifiers

NCT: NCT04382807 · 17/43/481

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗