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Behavioral Intervention

Experimental group for Tinnitus

N/A
Waitlist Available
Led By Vinaya Manchaiah, PhD
Research Sponsored by Lamar University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-intervention (8-weeks from baseline), 2-months post-intervention (16 weeks from baseline)
Awards & highlights

Summary

Nearly 50 million people in the U.S. experience tinnitus, of which about 20 million people have burdensome chronic tinnitus. Tinnitus can be very debilitating as many aspects of daily life can be affected, such as sleep, mood, and concentration. Currently, there is no cure for tinnitus. Pharmacological or sound-therapy based interventions are sometimes provided, but may be of limited value to certain individuals. Research suggests that Cognitive Behavior Therapy (CBT) based approaches have the most evidence of effectiveness in the management of tinnitus. However, CBT is rarely offered in the U.S. (less than 1%), partly attributed to a lack of trained professionals who can deliver CBT. To improve access to CBT for tinnitus, and online CBT program has been developed. The purpose of this study is to determine the feasibility and efficacy of a CBT Internet-based intervention for adults with tinnitus in the United States.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-intervention (8-weeks from baseline), 2-months post-intervention (16 weeks from baseline)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (8-weeks from baseline), 2-months post-intervention (16 weeks from baseline) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tinnitus Functional Index (TFI) - Measure of Tinnitus Distress
Secondary study objectives
EuroQol EQ-5D-5L VAS Scores; Measure of Health-related Quality of Life
Generalized Anxiety Disorder (GAD-7); Measure of Anxiety
Insomnia Severity Index (ISI); Measure of Insomnia
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Weekly check-in control groupExperimental Treatment1 Intervention
The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention.
Group II: Experimental groupExperimental Treatment1 Intervention
The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Internet-based Cognitive Behavior Therapy
2020
N/A
~500

Find a Location

Who is running the clinical trial?

Lamar UniversityLead Sponsor
3 Previous Clinical Trials
221 Total Patients Enrolled
2 Trials studying Tinnitus
181 Patients Enrolled for Tinnitus
Vinaya Manchaiah, PhDPrincipal InvestigatorLamar University
2 Previous Clinical Trials
181 Total Patients Enrolled
2 Trials studying Tinnitus
181 Patients Enrolled for Tinnitus
~56 spots leftby Oct 2025
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