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OpenTrials
Enrolling by invitation

NCT Number: NCT04382807

Internet-delivered Group Counseling for Chronic Tinnitus

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.

Enrolling by invitation

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Key information

Conditions

Tinnitus, Subjective Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tinnitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Antwerp

Antwerp, Belgium

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with subjective, chronic tinnitus

Exclusion criteria

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

Treatment and study plan

Counseling

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Visual Analogue scale (VAS) for tinnitus loudness

    Time frame: before intervention, 3 months follow-up

    Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus

  2. Change in Hospital Anxiety and Depression Scale (HADS)

    Time frame: before intervention, 3 months follow-up

    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.

  3. Change in Hyperacusis Questionnaire (HQ)

    Time frame: before intervention, 3 months follow-up

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
May 11, 2020
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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