CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 33 enrolled
Drug / intervention
Cognitive Behavioral Therapy +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00724152
NCT00724152Phase 2Completed

Cognitive-behavioral Therapy for Tinnitus

US Department of Veterans Affairs·interventional·Posted Jul 29, 2008·Updated May 6, 2015

In Brief

A Phase 2 clinical trial evaluating Cognitive Behavioral Therapy and Tinnitus Education for Tinnitus. Completed, enrolled 33 participants across 1 site.

Detailed Summary

This study examined how useful it is to teach veterans coping skills for dealing with tinnitus, also called ringing in the ears. A psychological intervention, cognitive-behavioral therapy, was used to teach coping skills even though tinnitus is not a psychological disorder. Participants in Period 1 of the study were assigned to one of two groups for the duration of the study and were blinded to their group assignment until the end of the study. One group received education about tinnitus. The other group received education about tinnitus plus additional ways to cope with problems associated with tinnitus such as sleep disturbance and frustration. Participants were selected to participate if their tinnitus was severe and they had been exposed to loud sound. Participants attended up to six weekly group meetings. It was predicted that participants who were randomly assigned to the cognitive behavioral therapy group would report a greater reduction in tinnitus severity than education controls. During Period 2 of the study, a third "standard care" arm was added. Baseline and outcome data of the 4 participants who completed the study after this third arm was added to the study design are not reported.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTinnitus
CountriesUnited States
CollaboratorsYale University

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 29, 2008
Enrollment StartFeb 1, 2009
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 17.9 years ago

Interventions

Cognitive Behavioral Therapybehavioral

A psychotherapeutic approach to tinnitus management which includes tinnitus education

Tinnitus Educationbehavioral

An audiologic rehabilitative approach to tinnitus education.