Cognitive Behavioral Therapy (CBT) for Tinnitus

Completed · Phase 1/Phase 2

Conditions studied: Tinnitus

In brief

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.

Key facts

Study ID

NCT00724152

Run by

US Department of Veterans Affairs

People needed

33

Starts

2009-02-01

Expected to finish

2011-02-01

Last updated by the study team

2015-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• VA Connecticut Health Care System (West Haven) — West Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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