Clinical trial NCT01015781: Multi-Site Evaluation of Progressive Tinnitus Management
Official title: Multi-Site Evaluation of Progressive Tinnitus Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: Tinnitus
Counseling
Education
Rehabilitation of hearing impaired
Triage
Evaluation studies
Quality of health care
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-11-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multi-site study evaluated the implementation of Progressive Tinnitus Management (PTM), which combines both Audiology and Psychology approaches to Tinnitus Management. Those Veterans who require intervention for tinnitus have different levels of need, and this progressive approach gives them the appropriate level of intervention.

Detailed description: Objectives. We completed 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 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 was to conduct a randomized clinical trial at multiple VA medical centers to evaluate the effectiveness and clinical utility of PTM as compared to Wait List Control.

Plan. The 3-year study was based at the VA National Center for Rehabilitative Auditory Research (NCRAR), and PTM was 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 were modified (especially with the addition of Cognitive-Behavioral Therapy - CBT); (b) training materials were developed (the web-based PTM training program for VA audiologists was updated; PTM training will be developed for VA psychologists); (c) by random selection, five audiologists (two in Memphis, three in West Haven) were identified to conduct PTM and five (two in Memphis, three in West Haven) were identified to conduct usual care; (d) the five PTM audiologists (the West Haven study psychologist developed the training). By month 7, the randomized clinical trial was implemented at the two VA sites and continued through year 3.

Methods. Prior to conducting the clinical trial, PTM was 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) were randomized into either PTM or Wait List Control. Self-perceived tinnitus handicap was evaluated pre- and post-intervention for each subject using the Tinnitus Handicap Inventory. The five audiologists and two psychologists who participate in this study were 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.

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 extends 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.

Eligibility criteria: Inclusion Criteria:

* are eligible for audiology services at their respective VAMC;
* 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);
* report that their tinnitus is at least a "small" problem; and
* are willing to give verbal consent.

Exclusion Criteria:

* are not Veterans;
* have received previous tinnitus services at their VAMC;
* report that their tinnitus is "no problem";
* are unable (for any reason) to fulfill all of the requirements of the study.

Primary outcomes:
measure: Tinnitus Functional Index Change Score
timeFrame: Baseline, 6 months (from Baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Health Care System (West Haven)
state: Connecticut
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
city: Memphis
country: United States
facility: VA Medical Center, Memphis
state: Tennessee
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: James A Henry, PhD
role: PRINCIPAL_INVESTIGATOR
References: