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NCT04382807 Clinical Trial

Internet-delivered Group Counseling for Chronic Tinnitus

Tinnitus, Subjective Clinical Trial

Official title:
Internet-delivered Group Counseling for Chronic Tinnitus

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04382807
Other study ID # 17/43/481
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 12, 2020
Est. completion date December 31, 2024

Study information
Verified date May 2023
Source University Hospital, Antwerp
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 traditional face-to-face delivery.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 150
Est. completion date December 31, 2024
Est. primary completion date December 12, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with subjective, chronic tinnitus Exclusion Criteria: - Enrollment in other tinnitus treatments simultaneously at the time of the intervention

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Belgium University Hospital Antwerp Antwerp

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Tinnitus Functional Index (TFI) Tinnitus severity self-report questionnaire, ranging from 0-100 with a higher score representing a more severe tinnitus. before intervention, 3 months follow-up
Secondary 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 before intervention, 3 months follow-up
Secondary 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. before intervention, 3 months follow-up
Secondary 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. before intervention, 3 months follow-up
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