Multi-Site Randomized Clinical Study of Tinnitus Treatment Methods
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      The purpose of this multi-site randomized clinical study was to assess treatment outcomes for
      three forms of tinnitus treatment: Tinnitus Retraining Therapy (TRT), Tinnitus Masking, and
      Tinnitus Education (TED). There were four study sites: VAMC Audiology Clinics at Bay Pines,
      FL; Portland, OR; Seattle, WA; and San Diego, CA. Thirty-six subjects (Veterans) were
      enrolled into treatment at each site - 12 into each treatment group. Each subject received 18
      months of treatment. Treatment appointments and outcome questionnaires occurred at 0, 3, 6,
      12, and 18 months. Qualified subjects were initially randomized to one of the treatment
      groups or to a 6-month Waiting List group. Those in the Waiting List group completed outcome
      questionnaires at 3 and 6 months, and were randomized into one of the three treatment groups.
      They then received 18 months of treatment as above.
    

Detailed description: 
      Although tinnitus is especially problematic for Veterans, the DVA has no established protocol
      for tinnitus rehabilitation. We recently completed a randomized clinical trial to evaluate
      the efficacy of tinnitus treatment for veterans. Tinnitus Masking and Tinnitus Retraining
      Therapy (TRT) were both shown to be effective for the majority of Veterans treated with these
      methods by expert tinnitus clinicians. The objective of the present study was to determine if
      the same level of treatment efficacy observed in the previous study could be obtained by
      typical VA audiologists in their clinical environment. In addition, a third group was added,
      called Tinnitus Education (TED), which served as a control group for nonspecific effects of
      treatment using a standardized protocol of hearing aids and education.

      Veterans with clinically significant tinnitus were recruited to receive treatment with
      Masking, TRT, or TED in Audiology Clinics at the Bay Pines, Portland, San Diego, and Seattle
      VAMCs. There were three Treatment Audiologists at each of the sites, one for each of the
      three treatment methods. Each method uses a variation of sound therapy and of educational
      counseling. Sound therapy involves the use of wearable ear-level devices, including sound
      generators (maskers), hearing aids, or combination devices (hearing aid and masker combined).
      Only the TED group was restricted to the use of hearing aids only (note: TED subjects who did
      not require hearing aids were the only subjects in this study who did not receive ear-level
      devices). TRT uses a structured counseling protocol that teaches concepts that are unique to
      TRT. The Masking protocol has been created to match the TRT counseling with respect to
      comparable formatting and length of counseling sessions, but containing information specific
      to the concepts of Masking. The TED counseling protocol is similarly matched in format and
      length, but the information conveyed is of a more generic nature (general audiologic
      counseling information). Assessment of outcomes utilized questionnaires that were
      administered at intervals before, during, and after the 18 months of treatment.

      Potential participants at all sites were telephone-screened by the Project Audiologist in
      Portland to determine if the tinnitus is a clinically significant problem warranting 18
      months of treatment. Veterans who passed the screening were scheduled to meet with the
      Research Coordinator (RC) at the respective study site. At this first visit, Veterans were
      consented, completed questionnaires, and were then informed as to their group placement. Per
      a randomization schedule, they were placed into one of the three treatment groups, or into
      the 6-month waiting list group (with treatment starting 6 months later). At the initial
      evaluation with the respective Treatment Audiologist, a tinnitus verbal interview was
      administered, hearing and tinnitus testing were performed, and ear mold impressions were
      taken to order the custom ear-level devices. The Veteran returned approximately 3-4 weeks
      later to be fitted with the devices and to receive the counseling/education that initiates
      treatment. Subjects returned for follow-up treatment at 3, 6, 12 and 18 months. At the
      follow-up appointments, the RC collected and checked the questionnaires, and the Treatment
      Audiologist administered the follow-up verbal interview and repeated the counseling protocol.
    

Intervention name(s): Tinnitus Masking; Tinnitus Retraining Therapy (TRT); Tinnitus Education (TED)
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Sound therapy with Tinnitus Masking is intended to produce immediate relief from the discomfort caused by tinnitus (Vernon, 1977; 1987; Vernon, 1988). If maskers or combination units are used, the masking sound can be set at any level the patient chooses to attain maximum relief. Relief using masking noise can be accomplished using the external sound of the masker, which is generally a more acceptable sound than the tinnitus.; The TRT procedure adheres as closely as possible to the methodology described by Dr. Pawel Jastreboff. For TRT, sound therapy is used to facilitate long-term habituation to tinnitus (Jastreboff, 1999b).; TED represents tinnitus treatment that would typically be provided by audiologists using hearing aids and counseling (although for this study the counseling has been structured and expanded to be equivalent in length to the other two groups).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Audiology; Rehabilitation; Tinnitus