**Transcript of Cyberseminar**

**Mild TBI Diagnosis and Management Strategies**

**Progressive Tinnitus Management: An Interdisciplinary Approach**

**Presenters: James Henry, PhD; Caroline Schmidt, PhD**

**September 30, 2013**

*This is an unedited transcript of this session. As such, it may contain omissions or errors due to sound quality or misinterpretation. For clarification or verification of any points in the transcript, please refer to the audio version posted at www.hsrd.research.va.gov/cyberseminars/catalog-archive.cfm or contact james.henry@va.gov or caroline.schmidt@va.gov.*

*Interviewer:*We are at the top of the hour, so at this time I would like to introduce Dr. Ralph DePalma, who will be introducing our speakers.

*Dr. DePalma:*It’s a pleasure to have James Henry, research career scientist and research professor in otolaryngology at the National Center for Auditory Research in Portland, Oregon and Caroline Schmidt, who’s a research psychologist at VA Connecticut Health System and a research scientist at Yale University.  As you heard they’re going to be speaking on Progressive Tinnitus Management, a very important issue, and then TBI.  Thank you.

*Interviewer:*Thank you, Ralph.  We’ll go ahead and start with Dr. Henry.  Again, please open to full screen mode Dr. Henry, and then you can just click the arrow right button.

*Dr. Henry:*Okay.  Well, thank you both for the introduction.  We appreciate this opportunity to make the presentation, which is based on many years of research we’ve conducted at the VA.  First of all, we have no disclosures to report.  We are both VA employees.  My position and most of my research at the National Center for Rehabilitative Auditory Research, or the NCRAR, is supported by VA Rehabilitation Research and Development, or RR and D.  Dr. Schmidt is a clinical psychologist at the VA Connecticut Healthcare System in West Haven, Connecticut.  A portion of her salary comes from RR and D.

We want to acknowledge in addition to Dr. Schmidt and myself, PTM was developed by Drs. Tara Zaugg and Paula Myers.  Dr. Zaugg works with me at the NCRAR and Dr. Myers is located at the James A. Haley VA Hospital in Tampa, Florida.  Here’s a whole bunch of other people that we want to acknowledge, and without going through them individually, we just want to thank them all for their support over the years.  They’ve all contributed to PTM and indirectly to this presentation.  

We’re going to do a series of poll questions.  Here’s poll question number one.  What is your primary role in the VA?  We’d like to know who’s on this call.  Are you a physician in primary care, a physician in specialty services, such as otolaryngology, psychiatry or anesthesiology, a mental health provider?  Do you work in audiology, or are you in another discipline not listed?  Please go ahead and select which one of these applies best to you.

*Interviewer:*Thank you very much Dr. Henry.  For our attendees you must be out of full screen mode to see the poll.  It looks like most of our audience has voted, so Dr. Henry if you’re out of full screen mode you should be able to see the results now if you want to talk through them real quick?

*Dr. Henry:*Okay.  I have to go out of full screen mode?

*Interviewer:*Correct.

*Dr. Henry:*Okay.  It looks like nobody is a physician in primary care, 4.6 percent physician in specialty services, such as otolaryngology, psychiatry, or anesthesiology, 25 percent, mental health providers, 32 percent, audiologist, or at least work in audiology, and 38.6 percent in another discipline not listed.  Thank you all for those responses.

*Interviewer:*Thank you.  Feel free to go back up into full screen mode if you’d like.

*Dr. Henry:*Okay.  What is tinnitus?  That’s the big question.  A transient ear noise is experienced by almost everyone.  It is a tonal or whistle type sound that comes on suddenly in one ear and then fades away.  The sound is accompanied by a sense of ear fullness and hearing loss.  After about a minute everything recovers.  Transient ear noise is a normal occurrence and should not be consider tinnitus, although unfortunately often it is.

The textbook definition of tinnitus is ear or head noise lasting at least five minutes and occurring at least twice a week.  This definition at least distinguishes tinnitus from transient ear noise, but is irrelevant for the great majority of our patients who experience chronic tinnitus.  Chronic tinnitus is always present even if it is not noticed or is masked by environmental sound.  If chronic tinnitus is suspected of your patient, a good question to ask is, “Can you usually hear your tinnitus if you listen for it in a quiet room?”

Okay, so now I think we’re going to move on to poll question number two.  Basically we just want to know, “Do you have tinnitus?”  We differentiated tinnitus from transient ear noise.  We’re not asking if you have transient ear noise because everybody does.  We’re asking, “Do you have chronic tinnitus?”  Please respond yes or no.  *[Pause]*

*Interviewer:*Thank you.  The answers are streaming in.  People are not shy about answering this one.  *[Chuckles]*  We appreciate it.  Looks like the answers have stopped streaming in, so you can go ahead Dr. Henry.

*Dr. Henry:*Okay, and this is very interesting.  Of all of you professionals on the phone it looks like about 42 percent have tinnitus.  You have chronic tinnitus.  It’s interesting because whenever we ask a group of professionals, usually audiologists, how many of them have tinnitus the prevalence rate is far higher than the typical prevalence rate in the adult population.  The prevalence rate is normally 10 to 15 percent of all adults have chronic tinnitus, but from this little survey we just did over 42 percent of our audience has chronic tinnitus.  You can relate on multiple levels.  

**Okay, so back to the presentation.  This is about Veterans who are service connected for tinnitus.  Tinnitus is the common individual disability for all Veterans receiving disability, as well as the most common disability of all new disability awards.  Aside from this huge economic impact of tinnitus disability more importantly is the emotional impact of tinnitus.  Many of our Veterans with blast or other combat related injuries experience result in chronic tinnitus, which serves as a constant reminder to them of that traumatic event.  These patients will likely require psychological intervention to alter these negative associations with tinnitus and to aid in coping with it.

This graph shows the number of Veteran service connected for tinnitus every year since 1994.  The year to year increase for the past 10 years is particularly dramatic.  As of fiscal year 2012, almost  a million Veterans were service connected for tinnitus.  Most of them receive a 10 percent service connection for their tinnitus disability.

These next two slides list risk factors for tinnitus that have been confirmed by epidemiology studies.  The most common cause is exposure to loud noise.  In the military TBI is a common cause.  Most of these risk factors relate to auditory disorders and indeed anything that can cause hearing loss can also cause tinnitus.  It’s important to note that the mechanisms for how these factors interact or cause tinnitus are not understood.

Although underlying mechanisms of tinnitus are not well understood the contemporary view is that tinnitus is often triggered by ear injury, but long term the neural generators are likely to be in the central auditory pathways.  Plasticity is the main component with reduced auditory nerve input triggering a shift in balance of excitation and inhibition centrally.  The onset and the maintenance of tinnitus probably involve different mechanisms.

Clinical and epidemiolic—I’m sorry.  Clinical and epidemiologic studies confirm that TBI is strongly associated with tinnitus.  Tinnitus can occur not only as a direct consequence of the event causing TBI, but also as a side effect of medications commonly used to treat cognitive, emotional, and pain problems associated with TBI.

Here’s our next poll question.  Are you involved in direct care of Veterans with TBI?  Please respond yes or no.  *[Pause]*

*Interviewer:*Thank you to our audience for responding to these.  It does help our presenters to guide along the presentation.  It looks like most people have answered, so I’ll go ahead and broadcast the results now.

*Dr. Henry:*Okay.  Survey says 78 percent of you are involved in direct care of Veterans with TBI.  Seventy-eight percent yes, twenty-two percent no.  Thank you very much for that.  *[Pause]*

When TBI is blast-induced the onset of tinnitus is even more likely that tinnitus is typically under reported in these cases.  A couple of studies support this statement.  For blast injured patients at the Walter Reed Army Medical Center 49 percent reported tinnitus.  In another group of blast injured patients at the Palo Alto VA Polytrauma Rehabilitation Center 38 percent reported tinnitus.

The issue of blast-induced tinnitus is so important that a special meeting was held in November of 2011 to address the subject, called the International State of Science Meeting on Blast-Induced Tinnitus.  The meeting involved collaboration between the DoD Blast Injury Research Program Coordinating Office, the DoD Hearing Center of Excellence, and the Department of Veterans Affairs.  There were 107 participants from 8 countries representing the DoD, VA, NIH, academia, medicine, and industry.

The objectives of the meeting were to assess current knowledge regarding cause, diagnosis and treatment of tinnitus, identify research gaps for further identification, or for further investigation, foster collaboration among researchers, and inform DoD research investment strategies.  Proceedings from the meeting were published, which included major findings and priority recommendations for research.

Key research questions on blast-induced tinnitus were developed including, “What are the clinical characteristics and co-morbidities of blast-induced tinnitus?  Are there different sub forms of blast-induced tinnitus?  How is blast-induced tinnitus associated with hyperacusis headache, depression, anxiety, and somatic modulation of tinnitus?  How is blast-induced tinnitus related to other blast-induced symptoms?  For example, migraines, memory impairment, or PTSD?”

Here’s more questions, and these are only about half of the questions that were published.  I’m not going to read through each one of these.  There’s many more, and they are available to read in the proceedings. 

The final conclusion of the meeting was continued research and development are needed to resolve key barriers in the ability to effectively diagnosis and treat tinnitus, and thereby reduce the impact of tinnitus on the DoD and the VA.  I do have a pdf copy of those proceedings.  Please feel free to email me with a request, and I’ll be glad to send it to you.

It almost goes without saying there is no cure for tinnitus.  One would never know this though if looking to the Internet for information about tinnitus.  Many websites claim to offer a cure for tinnitus and these are all scams.  There is no drug for tinnitus.  There is no drug that has received FDA approval for treating tinnitus.  Nevertheless drugs are often prescribed for tinnitus.  These drugs are proved to treat other conditions, such as depression, anxiety, insomnia, and epilepsy.

What can be done about tinnitus?  Many people experience tinnitus, but are not bothered by it, so the sound of tinnitus is not necessarily a problem.  Tinnitus becomes a problem when people react to it.  By react I mean they pay undue attention to it, and it affects their life in some significant way.  These reactions are the problem and patients need to learn how to manage their reactions.  Just like they would need to manage any other chronic condition.  

How can patients learn to manage their reactions?  There are three essential components to intervention.  First, and most importantly, they need good education, ideally to learn self-management skills.  Second, they need to learn how to use all forms of therapeutic sound effectively not just one form.  Third, they need to learn stress reduction techniques.

Which methods are effective?  There are many methods used to treat tinnitus.  Just Google tinnitus and you will be amazed at how many methods there are.  Most of these methods have no scientific basis and many of them are simply scams.  People with tinnitus are at a real disadvantage when seeking help because of the massive amount of misleading information that’s presented to them.

However, many of these “unscientific” methods work because of non-specific effects, i.e., the placebo effect.  Tinnitus is a subjective condition and highly vulnerable to positive outcomes due to high expectations.  This is not necessarily bad if the patient is getting quality care from an ethical provider.  It is, of course, far too easy to convince the unsuspecting person that some unproven method will help them, or even cure their tinnitus.

There are really only a handful of methods that have an evidence basis.  Here’s a list of the methods that have a reasonable degree of research support.  Hearing aids, although not technically a method, have long been known to help people who have tinnitus.  Hearing aids can relieve stress and the amplified sound can help patients pay less attention to their tinnitus.

Tinnitus masking has been around since the 1970s, started by Dr. Jack Vernon.  With masking the purpose is not to cover up or mask the patient’s tinnitus.  The purpose is to use sound to achieve a sense of relief from the stress or tension caused by tinnitus.  This is done through the use of ear level sound generators often called maskers that generate broadband sound.

Tinnitus retraining therapy, or TRT, has been around since the 1970s.  It was introduced by Dr. Pawel Jastreboff.  Sound is also used with this method, but for a completely different purpose than for masking.  With TRT sound is not intended to induce a sense of relief, but rather to create a background of sound to make the tinnitus less noticeable.

TRT also involves extensive counseling based on what’s called a neural physiological model.  This model is used to help patients understand that tinnitus is a meaningless neural signal.  The combination of sound therapy and counseling with TRT is designed to lead to habituation, meaning the patient does not normally pay attention to the tinnitus and does not react to it when it does come into consciousness.

Cognitive-Behavioral Therapy, or CBT, is a method that probably most of you are aware of.  CBT has been used for decades to treat depression, anxiety, and pain, and has also been adapted to tinnitus.  Components of CBT have been utilized in the method of progressive tinnitus management or PTM.

PTM is the method we’re focusing on today.  It is a result of our years of research and clinical experience.  It utilizes elements of hearing aids, masking, TRT, and CBT.  The key features of PTM are that it is a stepped-care approach.  It is based on education leading to self-advocacy.  It creates a framework for management that is flexible to accommodate different requirements of clinicians and patients.  

Then Neuromonics.  It’s unique because it’s a company, and the treatment provided by audiologists is controlled by the company.  Patients receive a proprietary MP3-like device that essentially plays relaxing music combined with broadband sound.  In the private sector this treatment costs about $5,000.00.  A new device was recently introduced by the company that sells for about $1,000.00.  We mention this method because it is in the literature, although all studies have been conducted by people who are affiliated with the company.  We do not advocate use of this method unless all other viable methods have been attempted without success.

Which method is the most effective?  Each of these methods has been shown to be effective for people.  However, the Cochrane Reviews, which critically review randomized clinical trials conclude that CBT has the strongest pure research evidence.  These reviews also conclude that sound therapy is effective when provided along with counseling.  The research does not prove that any one method is more effective than any other.

Here’s our fourth and final poll question.  Challenges to applying tinnitus interventions at your VA, select all that apply.  It can be one or more.  Lack of support by administration or staff allocation.  No available audiology staff.  No available mental health staff.  Not enough patients would be interested.  The interventions are too difficult to implement.  I want to see more research before implementing PTM at my site.  Please go ahead and choose one or more that apply to you.  Thank you.  

*Interviewer:*Thank you Dr. Henry.  It looks like answers are streaming in, so please folks take your time reading those options and select all that apply.  As far as challenges to applying tinnitus interventions at your VA.  Okay, and it looks like the results have slowed down.  If you want to briefly go over those?

*Dr. Henry:*Okay.  Challenges to applying tinnitus intervention at your VA.  Almost 60 percent say lack of support by administration.  Thirty-one percent say no available audiology staff.  Thirty-one percent say no available mental health staff.  Eight percent say not enough patients would be interested.  Almost 13 percent say the interventions are too difficult to implement.  Then 35 percent say I want to see more research before implementing PTM at my site.

We will address the last one because Dr. Schmidt is going to actually discuss our latest research results on PTM.  Thank you again for those responses.

*Interviewer:*Thank you so much.  We’ll just go ahead and switch over to Dr. Caroline Schmidt now.

*Dr. Henry:*Not quite yet.

*Interviewer:*Oh.  I apologize.  *[Chuckling]*

*Dr. Henry:*Let’s see.  I got to go back to full screen mode.  I’m not getting the arrows at the bottom.  Caroline, why don’t you go ahead and advance the slides?  We’ll now briefly review our research that has lead to the development of PTM.

Here’s a list of the six controlled clinical studies we’ve completed.  All of the research subjects were Veterans.  Starting in 1999 we conducted a study with 126 subjects comparing tinnitus masking and tinnitus retraining therapy or TRT.  Results showed significant improvement for both methods with TRT providing overall greatest benefit.

We next completed a group education study with 269 subjects comparing group education based on concepts from TRT to two control groups, a typical support group and a no-treatment group.  Results showed statistically significant improvement for the group education.

Next, we completed a study comparing masking, TRT, and as a control group, generic tinnitus education.  Surprisingly all three groups provided comparable benefits.  This study laid the groundwork for PTM.

The next study involved development and pilot testing of PTM.  We spent about two years developing the methodology and the necessary clinical and training materials.

Study number five addressed the concern that so many TBI patients also have bothersome tinnitus.  We adapted PTM to provide the intervention over the telephone and completed a pilot study with 36 subjects.  It was during this study that Dr. Schmidt added CBT to the PTM protocol.  Results of the pilot study showed that provision of PTM over the telephone is a viable method of intervention for patients with tinnitus and TBI.

Then finally Dr. Schmidt and her mentor, Dr. Robert Kerns, completed a pilot study to evaluate the use of CBT for tinnitus management with Veterans.  CBT was specifically tailored to use with Veterans in a VA setting.

There are four studies that are currently ongoing.  The first two are specific to PTM, and Dr. Schmidt will review them after we describe PTM.  The third study is comparing the use of hearing aids alone to hearing aids with a built-in noise generator.  The fourth study is being conducted by Dr. Bob Folmer at the NCRAR to evaluate the potential efficacy of a method known as Transcranial Magnetic Stimulation, or TMS.  TMS is approved for treating depression and it has been used for treating tinnitus.  Results for tinnitus thus far are equivocal, but promising.  

The method of PTM is based on 13 principals we’ve learned from our tinnitus research and from our collective clinical experience.  I’ll review the principles briefly.  Most importantly clinical services for tinnitus should be progressive.  Dr. Robert Dobie came up with this idea of a tinnitus pyramid.

Epidemiology studies, as I mentioned, show that about 10 to 15 percent of all adults experience chronic tinnitus.  If you put all these people into the pyramid the area below contains 80 percent of them who are not particularly bothered by their tinnitus.  Above that group is the approximately 20 percent who have bothersome tinnitus, which can be mildly, moderately, or severely bothersome.  At the tip of the pyramid is the relatively small number of people who are debilitated by their tinnitus.  The take home message is that only about 20 percent of those who experience tinnitus require tinnitus specific services and those who do need different levels of service.

Principle number two says to use an interdisciplinary approach.  Tinnitus management should include routine services by both audiologists and mental health providers with otolaryngologists available to conduct medical assessments as necessary. 

The third principle says clinicians need training in tinnitus management.  No professional discipline includes training in tinnitus management as a required component of their graduate program.  The training must be obtained elsewhere.  We often conduct training workshops and have developed an online training course. 

Principle four, approximately 90 percent of patients with tinnitus also have hearing loss.  A patient complaining of tinnitus should undergo a hearing evaluation by an audiologist.  In many cases audiology services are all a patient needs to address tinnitus.

He mentioned 80 percent of people with tinnitus are not particularly bothered by it.  It is therefore necessary to determine if the tinnitus is clinically significant, i.e., if tinnitus specific services are warranted.  

Principle six, the best way to determine if a patient’s tinnitus is clinically significant is to administer tinnitus questionnaires.  We recommend the use of three specific questionnaires for PTM.  Other than the routine audiology assessment no other testing is needed.

Principle seven, relates to the fact that many patients blame their hearing problems on their tinnitus.  These patients are very aware of their tinnitus, but they don’t realize they have a hearing loss, so they think the tinnitus is the cause of their hearing problem.  The hearing evaluation and tinnitus questionnaire supply the needed information to sort this out with patients.

Then next slide, principle eight, if patients require intervention for their tinnitus beyond basic audiology services, the intervention should start with patient education.  These patients are vulnerable to being enticed into buying expensive devices or procedures for treating their tinnitus.  With proper education they can make informed decisions about their tinnitus care.

Principle nine, the average patient has a health literacy level of about the sixth grade.  It is essential to keep this in mind, and to provide all materials and counseling at that level.

Principle ten, patients are best served if they learn self-efficacy skills.  This ties together principles eight, nine, and ten.  Patients need to be educated with appropriate information that focuses on teaching what to do about their tinnitus when it is problematic.

Principle eleven, earlier I mentioned different methods of tinnitus intervention that have research support.  Most of these methods involve the use of sound in some way to manage tinnitus.  Patients need to learn how to use sound therapeutically for tinnitus management.  PTM counseling goes into great detail on how to use different types of sound and sound devices to provide tinnitus management in situations when tinnitus is intrusive or bothersome.

Principle twelve, patients should learn psychological coping techniques.  This really refers to the coping techniques that are taught in conjunction with CBT.  CBT, as I mentioned, has the strongest research evidence for tinnitus management, and any program should involve the use of CBT.

Principle thirteen, we have demonstrated that patient education can be provided effectively by telephone.  I mentioned our pilot study with TBI patients and we are now conducting a major randomized clinical trial to expand on that study.

I’m now going to turn it over to Dr. Schmidt who will describe that trial following her overview of PTM.

*Dr. Schmidt:*Thanks Jim.  Now I’m going to talk a little bit about the overview of PTM, and describe some details about the intervention that we’ve developed to help patients manage tinnitus, and how we’ve modified this protocol for patients with TBIs.

The hierarchical levels of the clinic services with PTM are a step care approach.  It’s based on education leading to self-efficacy and it creates a framework for management that is flexible to accommodate differing requirements of clinicians and patients.  This is what Jim already mentioned, but it’s worth repeating.  It’s the result of our years of research and clinical experience.  It utilizes elements of hearings aids, masking, TRT, and CBT. 

This pyramid represents the entire population of adults with tinnitus.  You can see that most people down at the bottom of the pyramid are not bothered by their tinnitus and do not require any intervention for their tinnitus.  This is estimated to be approximately 80 percent of people who have tinnitus.  Then as you move up the pyramid people are progressively bothered by their tinnitus and need progressively more services to help them.  The top of the pyramid represents a very small percentage of people who are extremely bothered by their tinnitus and require one-on-one assistance in managing reactions to tinnitus.

The level one triage is among the five levels of care, and it’s the first level.  Triage is the initial point of contact when patients report to a provider, any provider, that they have tinnitus.  We have developed specific guidelines for non-audiologists to use to decide what to do when a patient complains of tinnitus.  Providers are often unsure about when to refer patients with tinnitus to an audiologist for an ear exam versus an ear, nose, and throat doctor or an ENT.  By the way an ENT doctor is sometimes called an otolaryngologist or a neurotologist, or a tologist.  Depending on their special emphasis.  There are specific symptoms that would warrant referrals for ENT exam because of their condition, such as tinnitus, and could be treatable or even dangerous.  These would include: pulsatar tinnitus, or somatosounds, ear pain, drainage or malodor, dizziness, vertigo, asymmetric hearing loss, one ear is worse than the other, or conductive hearing loss if this is known.  Also rapid changes in symptoms would be a reason to refer to ENT.

There are additional triage guidelines that you can find in an article we published in the *Journal of Family Practice* in 2009 describing the triage process.  You can find this on the NCRAR homepage that we’ll provide at the end of the presentation online or you can ask by email with us.  Our contact information for emails are also at the end of the presentation.

The level two audiologic evaluation is a referral, is what’s done after this referral process.  It starts typically in otolaryngology, and then somewhere other than audiology, but then eventually all patients should filter through audiology.  Once a patient has gone through triage and eventually ends up in the hands of an audiologist, he or she goes through the level two audiologic evaluation.

The level two audiologic evaluation primarily consists of a hearing test, a hearing aid evaluation, if needed, screening for sound tolerance problems, and a brief assessment of tinnitus impact to determine if tinnitus specific intervention is warranted.  If a patient is in need of hearing aids or other assistive listening devices, most devices will be fitted before the patient moves on to level three.  Very occasionally when a screening for sound tolerance problems, a sound tolerance problem is so severe that it will prevent a patient from being able to participate in a group setting, and this would be discovered.

Level two, in the rare cases when a patient does go through the Sound Tolerance Evaluation Management procedures, which is often referred to as STEM, they might want to get the sound tolerance problem under better control.  Then the patient can go on to level three group education for tinnitus as needed.  It’s pretty rare, although a patient, for a patient to need to go through STEM.  In most cases the patient goes through level two.  Then if it’s determined that the intervention for tinnitus specifically is warranted than the patient moves on to level three.  You could see where the STEM procedure happens there on the pyramid.

In level three, this consists of a series of five workshops.  Two of the five workshops are led by an audiologist.  The audiologist workshops focus on learning how to use sound to manage reactions to tinnitus.  Participants identify their most bothersome tinnitus situation and then learn how to use sounds that are soothing, sounds that are interesting, and neutral background sounds that will help them feel better during those times without changing the sound of the tinnitus.  Three of the five workshops are led by a mental health professional and these sessions are based on CBT.  The behavioral strategies include relaxation, and distraction, and the additional cognitive strategies are for managing emotional reactions to tinnitus. 

In level four, this is the interdisciplinary evaluation.  Experience tells us that most patients do not need to go, need help beyond the group education sessions or level three, but we don’t have any way of knowing that without checking with them.  About four to six weeks after the participants have completed the entire workshop series at level three they are contacted by telephone to see how they’re doing.  If it’s determined that a patient may need more than what is available through level three, then the patient moves on to level four.  

Level four consists of an in depth evaluation by both an audiologist and a psychologist to determine if one-on-one services by the audiologist, mental health provider, or both are warranted.  If at level four it’s determined that a patient is a good candidate for level five individualized support then that patient would meet one-on-one with audiologist and/or mental health provider.

At level five, the session is individualized and possibly somewhat expanded in terms of its version of level three.  It can be more individualized for that particular patient and the barriers they’re experiencing.  

These are the PTM workbooks that we’ve created.  There’s a clinician guideline handbook, which includes a CD, Power Point, files, and DVD of the group sessions, the PTM patient workbook, *How to Manage Your Tinnitus, A Step-By-Step Guide,* and the *PTM Counseling Guide*.  They’ve all been developed to provide the PTL clinical education guides and tools conduct PTM.  These materials were developed in conjunction with randomized clinical trials funded by the VA Rehabilitation Research and Development Service.  The clinical handbook for audiologists, clinical guide, and several hundred patients step-by-step workbooks were developed, distributed to all VA clinics last year.

Also available is a tinnitus brochure.  Those can be ordered free through the TMS catalogue.  Also through EES we’ve developed a 17-minute wonderful patient video that’s both informative and entertaining.  It also has seven other videos, five demonstrating the levels three workshops and two relaxation videos created specifically to cater to Veterans with tinnitus.  A 70-minute sound therapy tutorial is available in each patient workbook.  Lastly, a 19 module VA online tinnitus management training course is available online via TMS, if you want more information or to learn more about tinnitus.  All clinicians who work with patients with bothersome tinnitus are encouraged to take this training.  These materials were all developed in conjunction with EES.

Getting to the multi-site evaluation of Progressive Tinnitus Management, this is a recent controlled study of PTM that was carried out at two sites, Memphis, Tennessee and West Haven, Connecticut.  I’m pleased to report we’ve completed the intervention stage of this study, and now are on follow-up in terms of data collection.  Three hundred participants were enrolled in this study and we’re comparing subject to receive PTM to subject participants who were on a wait list control.  Among 228 participants who completed PTM they showed significant improvement.  The immediate care group showed significantly greater improvement on all three outcome measures compared to the wait list control group.  Most participants were using some sort of methods learned in the workbooks, or the workshops at follow-up.  So far only two participants continue to complain about tinnitus, so we’re seeing some great results.  Some of these participants have a history of TBI, but that was not specifically examined in this study.

For our next study though, we did specifically look at TBIs, and we’re still, this is ongoing.  This is a, we’ve mentioned this a moment ago, subjects were recruited nationwide primarily from VA and military hospitals.  Callers pass a screening, and are consented, and scheduled with the study psychologist to determine TBI status and to screen for mental health disorders.  The qualified candidates are either randomized to TelePTM immediate or six-month wait list control.

We modified PTM for patients with TBIs in this study and the pilot that led up to this study.  We modified the PTM for patients with TBI by delivering the protocol via telephone into participants’ homes.  We assessed TBI symptoms at baseline and asked participants to describe their memory impairments, concentration issues, and any other cognitive limitations that may affect their participation.  We incorporate these into our teaching style as needed.  We have a very organized method for helping participants keep a log of their telephone appointments.  We do reminder calls the day before or prior to appointments.  We also cater the session’s, the between session homework, which is what we sometimes call it, to the individual so that they have some things to work on, specifically for them in between sessions.  Lastly we utilize the participants’ support system as much as possible encouraging participants to share information with others and have them join the calls if they would like.  

Getting back to the TTE call, or the TTE study, the Telehealth Tinnitus Intervention for patients with TBI, there are seven telephone appointments with each participant.  These appointments are with the study psychologist or our audiologist at 1, 3, I’m sorry, 1, 2, 3, 4, 5 weeks and then at 3 and 6 months follow-up.  To date we’ve had 133 participants enrolled and we’ve seen some great results with the quantitative analyses.  There are the three measures, the three outcomes measures.  The TelePTM group shows statistically significant improvement as a whole.  Then the TelePTM immediate care group was improved significantly more than the wait list control, so we’re seeing some great results.  The qualitative analyses reveal that patients’ comments are overwhelmingly positive.

The current status of PTM is that the control studies show that it helps reduce symptoms and improve life satisfaction for tinnitus suffers.  It’s endorsed by the VA central office as an effective intervention for tinnitus and recommended for use at VA MCs.  Of course, it’s not routinely offered and sometimes Veterans suffering from tinnitus don’t receive this method.

The next step in our research is pre-implementation and this study proposes to assess barriers, facilitators, and readiness to conduct PTM across VA clinics.  A proposal was submitted titled *Implementation of Progressive Tinnitus Management: An Assessment of Readiness*.

Some long-term goals in terms of research of PTM are to include evaluating the implementation of PTM within the VA.  This includes PTM right in the VA clinics, but also using PTM using clinical video.  Making use of Telehealth and also making improvements to in home Telehealth.  The idea is to implement PTM nationally in a way that will increase and ensure patient access and ultimately reduce the burden of tinnitus among Veterans and other patients.

I’ve got a couple of case examples, but we’re short on time.  I know I want to leave a lot of time for questions.  I just want to get, I’ll get to the end here.  You can look over these case examples and let me know if you have questions.  These are some things that people are saying about PTM.  Some of the participants in our studies have said things like, “Noticing a difference started slowly, but I practiced the activities that were recommended to me, the more rapidly I experienced comfort and control.  I have found that using the tools provided are the keys to success.”  Someone else said, “Once I accepted that the program might work, it did.  I had problems thinking that anything would help my tinnitus.  Your program worked for me.  Thanks much.”  Someone said, “I have included listening to soft music and nature sounds to my daily activities to help me relax more.  And the breathing techniques help a lot as well.  Thanks for helping me with these things.”  Lastly, “As soon as my tinnitus becomes an issue in my life, I know how to react to it and continue on with a quality day.”

I want to thank you for listening to our presentation, and I know that there is going to be opportunity for some question and answering.

*Interviewer:*Thank you so much to both of our presenters.  I know a lot of our attendees joined us after the top of the hour, so I just want to let you know to submit a question or a comment for the presenters please use that Q and A box that’s located in the upper right hand corner of your screen.  Simply type your question or comment into the lower box and press send, and we’ll get to it in the order that it was received.  The first question we have, and I believe this came in when Dr. Henry was speaking.  Can we briefly consider indications for cochlear implant in association with auditory defect?

*Dr. Henry:*Yes.  A cochlear implants have been identified as being effective for tinnitus suppression in many patients.  When they started fitting cochlear implants the patients with tinnitus were reporting that their tinnitus loudness was reduced.  This kind of goes back to studies on electrical stimulation that have been done for decades.  They know that if they can do the right form of electrical stimulation to the inner ear they can suppress tinnitus.  They know that direct current is effective, but it also causes tissue damage.  Alternating current is less effective, but if they can get it to cross the right structures they can suppress the tinnitus.  They just have not figured out a way to do this as a clinically viable technique.  Still when their fitting cochlear implants, that’s directing electrical current directly to the auditory nerve and to the hair cells in the cochlear.  It’s noticed to suppress tinnitus in probably the majority of cases.  For some people there’s no effect and for other people it’s actually made their tinnitus louder.  There are some researchers who would like to do studies to actually do cochlear implants to suppress tinnitus for patients who are really in bad shape.  The problem with that is it destroys any hearing that’s in that ear.  We’re just a long way from actually using electrical stimulation as a clinical technique.

*Interviewer:*Thank you for that response.  The next question.  Where can we obtain patient workbooks?

*Dr. Henry:*If you’ll email either me or Dr. Schmidt we can provide a, it’s a list of PTM resources which includes all of the books, all of the videos, all of the everything that’s available.  A lot of these are available directly online in electronic version.  For example the self-help workbook is on the NCRAR website as a pdf version.  That’s a little cumbersome, but for some people they like electronic version.  Otherwise EES will provide the brochure, the self-help workbook, the 17-minute video, and the 2-video set, the 2-DVD set that has 7 videos if you’ll contact the Hines Distribution Center.  If you contact me or Dr. Schmidt we can send you instructions for how to contact EES to get those ordered and sent to you.

*Dr. Schmidt:*Also, they were distributed to the audiology clinics.  If you’re not in your audiology clinic your clinic might actually have some left, so you could check there too.

*Interviewer:*Thank you both.  The next question.  I wonder if a sound could be generated with a “canceling wavelength” to mask the tinnitus”?

*Dr. Henry:*They’ve done studies on trying to phase shift the tinnitus.  In other words if you add sounds together that are 180 degrees out of phase you will, one sound will cancel out the other.  That’s how those earphones work, those noise-reducing earphones.  Tinnitus is not an acoustic signal, so there is no phase with tinnitus.  There’s no way that you can cancel tinnitus by presenting the same signal that’s a 180 degrees out of phase.  There may be other ways to suppress tinnitus and there are all kinds of theories on how to use sound for that purpose.  I guess you’re thinking the right way.  We need ways to suppress tinnitus on a long-term, permanent basis.  So far nobody’s figured out exactly how to do that.

*Interviewer:*Thank you for that reply.  We do have several more questions.  Which tinnitus questionnaire do you recommend?

*Dr. Henry:*I’ll let Dr. Schmidt answer that one.

*Dr. Schmidt:*Well, there are a couple.  There’s the recent one that Jim and a bunch of other researchers put together, which is *Tinnitus Functional Index.*  Which is a really nice new questionnaire that can help you really sort out the various problems that people are having.  It’s nice because it has individual independent subscales.  It’s great.

If you’re doing a quick screening of Veterans or the patients I recommend *The Tinnitus in Hearing Survey*, the THS.  We have that available.  It has three sections, and it’s pretty rapid for patients to respond to.  It’s nice because it has one section for your tinnitus, one section for hearing loss, and another section for sensitivity to sound.

A lot of patients will blame their tinnitus on their hearing loss, and this questionnaire helps you say, “Look these are the things, the problems that you’re having because of your tinnitus.  These are the problems you’re having because of your hearing loss.  And this part is your sound sensitivity.”  It helps really outline that for patients who might be blaming their hearing loss on their tinnitus.  That would be an essential questionnaire.

The most widely used questionnaire at this point is *The Tinnitus Handicap Inventory,* the THI.  That is a nice questionnaire because you can do a lot of comparisons and other clinicians are very familiar with it.  I’m using that currently in researches in major outcome measures.  That can give you a lot of details.  It’s pretty long, relative to the other questionnaires, so it’s a good one as well.

*Interviewer:*Thank you for that reply.  You may have covered this already.  How do you get the materials and manuals for PTM?

*Dr. Henry:*Okay, I did cover that and I’ll let Caroline maybe say a few more comments.

*Dr. Schmidt:*Yeah, just by contacting is really a great way.  You can get them through EES.  If you know of a colleague or someone who is not in the VA or not a patient at the VA, you can refer them to Plural Publishing where these materials are also available.  We don’t make any royalties or anything off of those, but we wanted them to be available to non-VA providers and non-Veterans.

*Interviewer:*Thank you for that reply.  Could you provide more detail about level four of the PTM protocol?  What tools and tests you used to determine who will go on to level five?

*Dr. Henry:*Level four is a combination of a comprehensive assessment by both an audiologist and a mental health provider, specifically a psychologist, when you’re doing this assessment.  I’ll just comment on what the audiologist does and then Caroline can comment on what the psychologist does.

Both visits need to be about an hour long.  Basically everything up until this point is assumed that we’ve had this sort of generic population of patients who all have a similar problem and the same types of strategies work for most patients.  It turns out that over 95 percent of the patients who attend level three do not need or want any further services.  For the five percent or less that do need further services, they’re the ones that bump up to level four.

We schedule them with an audiologist for an hour.  We schedule them for a psychologist for an hour.  What the audiologist does, we’ve developed an interview.  We really rely mostly on the interview form.  We still administer the same questionnaires.  Specifically the *Tinnitus Functional Index* and the *Tinnitus and Hearing Survey,* and then also one that we’ve developed specifically for PTM called the *Self-Management for—*

*Dr. Schmidt:**Managing Reactions to Tinnitus.*

*Dr. Henry:*Thank you, Caroline.  *[Chuckling]*  We got too many acronyms and too many questions.  Anyway, we administer those three written questionnaires.  We review the results.  Then we administer the, it’s called, I believe, *The Tinnitus Interview*, and it’s in the back of our workbook.  The questions are designed to really get at what’s going on with that patient from an audiologist prospective.  The audiologist will get all of the information they need by reviewing the questionnaires and by conducting the interview.  Then I’ll let Caroline talk about what the psychologist does at level four.

*Dr. Schmidt:*If the psychologist does a brief interview with the patient and we typically do these back to back, so we’ll have the patient come in for the audiological evaluation, the more in depth one, and then also the interview with the, here at this site we use health psychologists.  It’s a nice model and the intakes are similar to other intakes that you would do for health purposes for psychology.  You’re assessing any barrier to implementing the strategies that we provide.

In level three we’re asking about, specifically about mental health symptoms because up to that point none of the patients or participants have seen a psychologist individually.  They’ve only been coming to group sessions.  This is the time where okay you’re identifying those people who aren’t going to get what they need just from this group process.  They need a little bit more, and you’re identifying what kinds of mental health symptoms might be co-morbid with their tinnitus, and what kinds of additional help that they might need, and you’re pulling in the resources that they might need in order to address mental health problems and what barriers they might be having to implementing the strategies.  That’s typically what’s done at level four.

*Interviewer:*Thank you both for those replies.  We do have two pending questions.  I just want to let you know several people have written in saying thank you this has been very helpful.  The next question.  Is there any association between vestibular hypofunction and tinnitus?  I have had some patients after finishing a course of vestibular therapy consisting of accommodation and habituation report that their tinnitus is less.

*Dr. Henry:*Wow, good question.  There’s really not such a direct relationship, so we don’t have a lot of tinnitus patients who also report a vestibular problem.  Unlike hypoechosis it seems like a lot of patients report that they have a sound tolerance problem.  However, the vestibular system is part of the inner ear, and so again anything that can affect the inner ear can cause hearing loss, tinnitus, hypoechosis, and vestibular problems.

The vestibular problems seem to be more associated with systemic diseases of the inner ear and also blockage of the semicircular canals.  Those can happen independently of tinnitus.  Meniere’s Disease typically has the symptoms of low frequency roaring tinnitus along with a fluctuating hearing loss and fluctuating vestibular symptoms.  These are dizzy patients.

I would say that if a patient has vestibular problems they should be treated specifically for the vestibular problems.  If they have tinnitus in conjunction with that, and it can’t be resolved, then the methods that we’re talking about today would be appropriate for those patients.  I’m not sure if I did a great job of answering that question, but that’s the best I can do.

*Interviewer:*Thank you for that reply.  The person is more than welcome to write in if they want further explanation.  The next question.  Is there someone who could supervise/consult with a psychologist who wanted to implement this for the first time?

*Dr. Schmidt:*Well, they could certainly contact me if they’re interested in finding out a little bit more about it.  One of the other supervisors who have provided CBT for pain and other kinds of conditions that might be similar to tinnitus would certainly be an appropriate supervisor.  You would need to have a background in psychology and providing CBT first.  That’s how to do that would be something that you would need to look into sort of separately.  Theses kinds of tools and information that we have are really for people who, for mental health providers who has experience in providing CBT for other conditions first.  We would like to get more materials out there for mental health providers, and hope to in the future.

*Dr. Henry:*I’ll kind of add to that.  That we have, basically tinnitus sort of seems to naturally fall into the scope of practice of audiologists.  In fact it is part of our scope of practice.  Even though we don’t receive specific training in our audiology programs.  Some audiology programs do, but most don’t.  Audiologists typically aren’t well trained in tinnitus management even though these patients are reporting tinnitus to audiologists every day.  Then mental health providers I think tinnitus is really generally not on their radar.  Patients report tinnitus to them they most likely don’t have a program for them.

Interestingly a CBT has the most research support, and specifically in Europe and Australia they’ve been doing CBT research for tinnitus for decades.  They’ve really established this program of CBT for tinnitus, but in the United States tinnitus is not really so much recognized by psychologists as being in their scope of practice.  It really should be, and so we want to emphasis that.  We want to bring psychologists in.  We want to work with them.  We want to train them, but we’re just behind.  We have all the materials developed for audiologists and we have some materials developed for psychologists, but we have a long way to go to develop these comparable materials for psychologists.  In fact we’re at a point now where we’re trying to get the help we need to put those materials together.

*Interviewer:*Thank you for the reply.  We do have one final question that’s come in.  Have you found PTM is helpful with PT, I’m sorry, with patients with co-existing psychiatric disorders?

*Dr. Henry:*I’ll let Dr. Schmidt answer that.

*Dr. Schmidt:*Absolutely, it is certainly very helpful.  Certainly if the person needs additional help for those co-morbid psychiatric conditions then PTM is a nice introduction to the kinds of strategies that they can use for their mental health conditions.  I’ve had that happen if PTM occurs first.  If people who have psychiatric conditions have had treatment before then the model that we use is familiar to them.  People will say, “Oh yeah, I’ve used this before in my PTSD groups,” or “Yeah, this is very similar,” and it’s useful for applying that knowledge to these kinds of strategies.  It certainly is applicable and very useful with people with co-morbid psychiatric problems.

*Interviewer:*Thank you very much.  That is the final question that’s come in, so I’d like to give each of you a chance to just make any concluding comments you’d like to.  We can go ahead and start with you, Dr. Henry.

*Dr. Henry:*Okay.  I’d just like to thank everyone for calling in and/or watching this on their computer.  We appreciate it.  We are doing all we can to make a program available for Veterans, for VA clinicians and to make it an accessible program.  We’re moving in the direction of Telehealth as much as we can, and we need to conduct Telehealth studies.  We’re doing it over the telephone.  Some people call that Telehealth and some people say that’s not Telehealth, but we are providing the services remotely and we’re getting very good results.

We think that beyond the basic audiology evaluation and hearing aids, if needed, all of the services can be provided remotely.  Because it does focus on education and all of this can be done over the telephone.  We mail them our workbooks.  We work with them over the telephone.  This could be video conferencing.  It could be in a person’s home.  It could be done remotely to C box.  There’s all kinds of ways this methodology can be implemented.

We do hope to get further funding to do our next pre-implementation study followed by an implementation study.  Stay tuned and hopefully we’ll have another opportunity to do another webinar in the next couple of years.

*Dr. Schmidt:*Yeah, I just want to...  just quickly I’ll thank Molly for being the moderator and to Dr. DePalma for inviting us to do this presentation today.  It was a little bit of a different spin on things for us to talk about TBIs, and it was very much welcomed because we have a lot of experience now with the topic.  Thank you to everybody for joining us.

*Interviewer:*Thanks.  I too would like to send my thanks to you both for providing your expertise to the field and also to our attendees for joining us.  I would like to plug the next TBI cyber seminar, which is happening on October 10th at 2:00 p.m.  The topic for that is Photo Sensitivity After TBI: Mechanisms, Diagnosis, and Treatment.  That will be presented by Dr. Cardone.  Cardon, I’m sorry.

For our attendees, when I close this session you are going to automatically have a survey that pops up on your screen.  Please do take a moment to provide feedback on this session as your opinion does help guide us where we go next and who we have present.  Thank you once again to Drs. DePalma, Schmidt, and Henry, and to our audience.  Please have a wonderful day everyone.

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