Status:
COMPLETED
Cognitive Behavioral Therapy (CBT) for Tinnitus
Lead Sponsor:
US Department of Veterans Affairs
Collaborating Sponsors:
Yale University
Conditions:
Tinnitus
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
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 hav...
Eligibility Criteria
Inclusion
- 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 their lives.
- 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 appointments.
- Tinnitus was a significant health concern for all subjects.
- Women and minorities were recruited.
Exclusion
- 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 excluded.
- 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 tinnitus.
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00724152
Start Date
February 1 2009
End Date
February 1 2011
Last Update
May 6 2015
Active Locations (1)
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1
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516