NCT04382807

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started May 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
May 2020Dec 2027

First Submitted

Initial submission to the registry

May 5, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

May 12, 2020

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2027

Expected
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

7.6 years

First QC Date

May 5, 2020

Last Update Submit

April 27, 2026

Conditions

Keywords

tinnitus treatmentdelivery methodpsycho-educational counselinginternet-based

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in Visual Analogue scale (VAS) for tinnitus loudness

    before intervention, 3 months follow-up

  • Change in Hospital Anxiety and Depression Scale (HADS)

    before intervention, 3 months follow-up

  • Change in Hyperacusis Questionnaire (HQ)

    before intervention, 3 months follow-up

Study Arms (1)

Subjective, chronic tinnitus

Tinnitus patients who received internet-based psycho-educational counseling

Behavioral: Counseling

Interventions

CounselingBEHAVIORAL

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

Subjective, chronic tinnitus

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjective, chronic tinnitus patients

You may qualify if:

  • Patients with subjective, chronic tinnitus

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Antwerp

Antwerp, Belgium

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Counseling

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 11, 2020

Study Start

May 12, 2020

Primary Completion (Estimated)

December 12, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations