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.
The objectives of this study were to (1) develop a novel, integrative, psychological
intervention, specifically cognitive-behavioral therapy (CBT), for the treatment of tinnitus
among veterans who have past exposure to loud noise, and (2) accrue preliminary data
examining the efficacy of the approach relative to standard care with education (ED) control
conditions. Tinnitus was the most common service-connected disability among veterans
2006-2012. Interventions for tinnitus are few and no cure exists. This pilot study examined
the feasibility and efficacy of providing individualized (CBT) for veterans with bothersome
tinnitus. Twenty-five veterans were recruited and randomly selected to one of two
conditions during Period One of the study; the treatment condition (CBT) or (ED) control. A
CBT manual and an ED manual were developed for this study. Subjects were be eligible for
the study if their tinnitus was likely caused by noise exposure, their tinnitus was chronic
(> 6 months), tinnitus was a major health concern for them, and participants were able to
commit to a 6-week course of treatment at the West Haven location of VACHS. Subjects were
veterans blinded to the treatment group to which they are assigned if ED or CBT. The THI
served as the primary outcome measure and the TRQ served as the secondary outcome measure
pre- and post-treatment follow-up. Results of this pilot project were used to inform the
design and methods of future rigorous randomized controlled clinical trials of CBT for
tinnitus following its incorporation into the Progressive Tinnitus Management (PTM)
protocol. 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 as this third arm essentially
modified the design such that a new study began but was not completed.
- All subjects were veterans who are currently receiving care at VACHS.
- Subjects were interested in participating in the study and had moderate to severe,
chronic (>6 months) tinnitus.
- Following a brief assessment of tinnitus severity by the project coordinator,
the research otologist and research audiologist conducted tinnitus and
audiological evaluations to determine subject eligibility.
- The most likely etiology of subjects' tinnitus was noise exposure to and all
eligible participants reported having been exposed to loud sound some time in
- Subjects indicated that they were motivated to comply with treatment and able to
commit to a 6-week course of treatment, follow-up, and study participation by
continuing to reside nearby.
- Subjects had stable, permanent housing and transportation means for follow-up
- Tinnitus was a significant health concern for all subjects.
- Women and minorities were recruited.
- Subjects responded to five assessment measures to determine exclusion from the study.
- Tinnitus-Impact Screening Interview (TISI): Those who scored 4 or lower were
excluded from the study.
- Semi-Structured Clinical Interview for Tinnitus: The exclusionary criteria
described below were assessed using this measure.
- Structured Clinical Interview for Diagnosis, abbreviated - Interview/Non-patient
(SCIDa-I/NP): If there was any indication of psychosis on this measure, the
subject was excluded from the study.
- Tinnitus Handicap Inventory (THI): Subjects with scores of 19 or lower were
- Tinnitus Reaction Questionnaire (TRQ): Subjects who scored 16 or lower on this
measure were excluded from the study.
- Subjects who were undergoing litigation or legal matters related to auditory
disorders were excluded from the study.
- Subjects must never had previously received psychological treatment for their
- Subjects with otherwise treatable tinnitus were excluded.
- Subjects who had a history of psychotic disorders or dementia were excluded.
- These psychotic symptoms constituted exclusion from the study:
- delusions of reference
- persecutory delusions
- religious delusions
- grandiose delusions
- somatic delusions
- delusional guilt
- poverty or nihilism
- delusions of jealousy
- delusions of mind reading
- delusions of being controlled
- delusions of thought-broadcasting
- auditory hallucinations
- visual hallucinations
- tactile hallucinations
- gustatory and olfactory hallucinations
- Subjects who report having a recent (within 3-month) history of alcohol or drug abuse
or dependence other than tobacco or caffeine were excluded.
- Subjects who presented with sudden or fluctuating hearing loss were excluded.
- Subjects with tinnitus associated with otologic disease (e.g., Meniere's Disease) or
other co-occurring diseases affecting vestibular dysfunction were excluded.