Internet-delivered Group Counseling for Chronic Tinnitus

May 9, 2023 updated by: Laure Jacquemin, University Hospital, Antwerp
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.

Study Overview

Status

Enrolling by invitation

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Antwerp, Belgium
        • University Hospital Antwerp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Subjective, chronic tinnitus patients

Description

Inclusion Criteria:

  • Patients with subjective, chronic tinnitus

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjective, chronic tinnitus
Tinnitus patients who received internet-based psycho-educational counseling
Online delivered group counseling session, providing insights into the tinnitus symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
before intervention, 3 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before intervention, 3 months follow-up
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.
before intervention, 3 months follow-up
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.
before intervention, 3 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2020

Primary Completion (Anticipated)

December 12, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (Actual)

May 11, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tinnitus, Subjective

Clinical Trials on Counseling

3
Subscribe