- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04382807
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
Conditions
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
-
-
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Antwerp, Belgium
- University Hospital Antwerp
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-
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
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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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17/43/481
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.
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