Internet-delivered Group Counseling for Chronic Tinnitus

• Conditions: Tinnitus, Subjective
• Interventions: Behavioral: Counseling

• Registration Number: NCT04382807
• Lead Sponsor: University Hospital, Antwerp

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-08
• Study First Posted: 2020-05-11
• Study Start: 2020-05-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2025-12-12
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients with subjective, chronic tinnitus

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjective, chronic tinnitus	Counseling	Tinnitus patients who received internet-based psycho-educational counseling

Primary Outcome Measures

Name	Time	Method
Change in Tinnitus Functional Index (TFI)	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 Outcome Measures

Name	Time	Method
Change in Visual Analogue scale (VAS) for tinnitus loudness	before intervention, 3 months follow-up	Visual analogue scale measuring tinnitus loudness from 0-100, with a higher score representing a louder tinnitus
Change in Hospital Anxiety and Depression Scale (HADS)	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.
Change in Hyperacusis Questionnaire (HQ)	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.

Trial Locations

Locations (1)

University Hospital Antwerp; 🇧🇪 Antwerp, Belgium