CBT-based Internet Intervention for Adults With Tinnitus in the United States

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

No Placebo-Only Group

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.

Eligible Conditions

Tinnitus

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-intervention (8-weeks from baseline), 2-months post-intervention (16 weeks from baseline)

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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