Clinical trial NCT00724152: Cognitive Behavioral Therapy (CBT) for Tinnitus
Official title: Cognitive-behavioral Therapy for Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Tinnitus
Keywords: coping skills
psychology
audiology
veterans
tinnitus
adult
intervention studies
tinnitus, noise induced
noise
auditory perception
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Yale University
First posted: 2008-07-29
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Tinnitus Handicap Inventory (THI)
timeFrame: pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks after session 1)
Secondary outcomes:
measure: Tinnitus Reaction Questionnaire (TRQ)
timeFrame: pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks later)
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Health Care System (West Haven)
state: Connecticut
Study officials:
affiliation: VA Connecticut Health Care System (West Haven)
name: Robert D. Kerns, PhD
role: PRINCIPAL_INVESTIGATOR
References: