Multi-Site Evaluation of Progressive Tinnitus Management

Objectives. We currently are completing a single-site pilot project to develop and evaluate
Progressive Tinnitus Management (PTM). PTM takes into account the fact that most Veterans
who complain of tinnitus do not require extensive intervention. The method thus is
"progressive" in that a hierarchical approach is used to provide clinical services only to
the degree needed by individual patients. Preliminary analyses of our pilot data provide
evidence that PTM is an effective and efficient means of providing tinnitus management
services to Veterans. Importantly, The Veterans Affairs (VA) Audiology and Speech Pathology
Program Office has tentatively identified PTM as a standardized method of tinnitus
management for use at all VA medical centers. It is essential to more definitively evaluate
PTM for routine application at VA medical centers. Accordingly, the specific aim of this
study is to conduct a randomized clinical trial at multiple VA medical centers to evaluate
the effectiveness and clinical utility of PTM as compared to usual care.

Plan. The 3-year study will be based at the VA National Center for Rehabilitative Auditory
Research (NCRAR), and PTM will be implemented and evaluated in a randomized clinical trial
at the Memphis VA Medical Center and at the VA Connecticut Healthcare System (West Haven).
During months 0-6: (a) All clinical materials for conducting PTM will be modified
(especially with the addition of Cognitive-Behavioral Therapy - CBT); (b) training materials
will be developed (the web-based PTM training program for VA audiologists will be updated;
PTM training will be developed for VA psychologists); (c) by random selection, five
audiologists (two in Memphis, three in West Haven) will be identified to conduct PTM and
five (two in Memphis, three in West Haven) will be identified to conduct usual care; (d) the
five PTM audiologists and the West Haven psychologist will receive PTM training (the West
Haven study psychologist will develop the training). By month 7, the randomized clinical
trial will be implemented at the two VA sites and will continue through year 3.

Methods. Prior to conducting the clinical trial, PTM will be modified to incorporate
critical components of CBT at all levels of intervention so as to address the psychological
effects of tinnitus. Qualifying Veteran subjects (n=150 at each site) will be randomized
into either PTM or usual care. Self-perceived tinnitus handicap will be evaluated pre- and
post-intervention for each subject using the Tinnitus Handicap Inventory. The five
audiologists and two psychologists who participate in this study will be interviewed to
determine their level of satisfaction with the PTM protocol to which they are assigned.
Evaluation of the program will determine its efficacy, and will identify areas of needed
improvement.

Although quantitative efficacy data are not yet complete, a great deal has been learned from
the study for which the current proposed study would be a continuation. A preliminary
process evaluation has revealed mostly positive results of implementing the PTM protocol at
the James A. Haley (Tampa) Veterans' Hospital. The process evaluation has already indicated
a number of changes that need to be made to the protocol, and those changes will be made for
the continuation study.

Relevance to VA's Mission. Although tinnitus is the second most common service-connected
disability, most VA medical centers do not provide comprehensive clinical services for
Veterans suffering from tinnitus. This study will extend our current work, which has focused
on the development of a comprehensive tinnitus management protocol that can be implemented
efficiently in VA hospitals. Further development of PTM has the potential of providing
needed tinnitus services to Veterans across the country for a relatively small cost and with
minimal impact on individual VA hospitals.

Inclusion Criteria:

Inclusion criteria include Veterans who:

1. are eligible for audiology services at their respective VAMC;

2. report the chronic presence of tinnitus (i.e., they have tinnitus that they can
usually hear when they listen for it in a quiet room);

3. report that their tinnitus is at least a "small" problem; and

4. are willing to give verbal consent.

Exclusion Criteria:

Individuals will not be enrolled in this study if they:

1. are not Veterans;

2. have received previous tinnitus services at their VAMC;

3. report that their tinnitus is "no problem";

4. are unable (for any reason) to fulfill all of the requirements of the study.