Cognitive Behavioral Therapy (CBT) for Tinnitus

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00724152
First received: July 23, 2008
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

This study examines 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, will be used to teach coping skills even though tinnitus is not a psychological disorder. Participants will be assigned to one of two groups for the duration of the study and will not know which group they are in until the end of the study. One group will receive education about tinnitus. The other group will receive education about tinnitus plus additional ways to cope with problems associated with tinnitus such as sleep disturbance and frustration. Several questionnaires will be filled out by veterans interested in participating in the study. Participants will be selected to participate if their tinnitus is severe and they were exposed to loud sound. Some veterans may not be eligible to participate if they have additional health conditions. About 66 veterans will be enrolled in the study. If selected to participate in the study, veterans in selected groups will attend six weekly group meetings. Participants will then be asked to come back 8 and 24 weeks after the last group to answer more questions about their tinnitus and health. It is predicted that participants who are assigned to the cognitive behavioral therapy group will report a greater reduction in tinnitus severity than the standard care and education controls.


Condition Intervention Phase
Cognitive Behavior Therapy
Health Education
Tinnitus
Behavioral: Cognitive Behavioral Therapy
Other: Tinnitus Education
Other: Standard Care
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Cognitive-behavioral Therapy for Tinnitus

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Tinnitus Handicap Inventory (THI) [ Time Frame: Eligibility, pre-treatment, post-treatment, 8- and 24-weeks post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tinnitus Reaction Questionnaire (TRQ) [ Time Frame: Eligibility, pre-treatment, post-treatment, 8- and 24-weeks post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: February 2009
Estimated Study Completion Date: February 2015
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Participants randomly assigned to this control group will receive six weeks of tinnitus education.
Behavioral: Cognitive Behavioral Therapy
Cognitive behavioral therapy for tinnitus participants will address cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency will be used emphasized. The major components of CBT for tinnitus include identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions (such as negative appraisals) and change behaviors (such as avoidance of social activities), and reinforcement of skills via goals setting, homework and activities. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques will be provided.
Other: Tinnitus Education
Tinnitus education will include causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources.
Other: Standard Care
Standard care will involve audiological measurement and brief education during the standard care appointment.
Experimental: Arm 2
Participants randomly assigned to this experimental group will receive six weeks of tinnitus education plus cognitive behavioral therapy.
Behavioral: Cognitive Behavioral Therapy
Cognitive behavioral therapy for tinnitus participants will address cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency will be used emphasized. The major components of CBT for tinnitus include identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions (such as negative appraisals) and change behaviors (such as avoidance of social activities), and reinforcement of skills via goals setting, homework and activities. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques will be provided.
Other: Tinnitus Education
Tinnitus education will include causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources.
Other: Standard Care
Standard care will involve audiological measurement and brief education during the standard care appointment.
Active Comparator: Arm 3
Participants randomly assigned to this control group will receive only standard care.
Behavioral: Cognitive Behavioral Therapy
Cognitive behavioral therapy for tinnitus participants will address cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency will be used emphasized. The major components of CBT for tinnitus include identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions (such as negative appraisals) and change behaviors (such as avoidance of social activities), and reinforcement of skills via goals setting, homework and activities. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques will be provided.
Other: Tinnitus Education
Tinnitus education will include causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources.
Other: Standard Care
Standard care will involve audiological measurement and brief education during the standard care appointment.

Detailed Description:

The objectives of this study are 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) and standard care control conditions. Tinnitus was the most common new individual service-connected disability in fiscal year 2006. Treatments for tinnitus are few and no cure exists. This pilot study will examine the feasibility and efficacy of providing individualized (CBT) for veterans with bothersome tinnitus. Sixty-six veterans will be recruited and randomly selected to one of three conditions; the treatment condition (CBT), the (ED) control condition, or the standard care (UC) condition. A three-group design with two continuous dependent variables will be used to compare improvements among the control groups (ED and UC) and the experimental group (CBT). Covariates will include age and number of months with tinnitus. It is hypothesized that the CBT group will improve greater (get lower scores on the THI and TRQ than the ED and UC groups) though not to the level of statistical significance. A CBT manual and an ED manual will be developed for this study. Subjects will be eligible for the study if their tinnitus was likely caused by noise exposure, their tinnitus is chronic (> 6 months), tinnitus is a major health concern for them, and participants are able to commit to a 6-week course of treatment at the West Haven location of VACHS. Subjects will be veterans blinded to the treatment group to which they are assigned if ED or CBT. Potential subjects will respond to five assessment measures to determine inclusion in the study: (1) Tinnitus-Impact Screening Interview (TISI) , (2) Semi-Structured Clinical Interview for Tinnitus (SSCIT), (3) Structured Clinical Interview for Diagnosis, abbreviated - Interview/Non-patient (SCIDa-I/NP), (4) Tinnitus Handicap Inventory (THI), and (5) Tinnitus Reaction Questionnaire (TRQ). Subjects will attend six group meetings and undergo evaluations before three group meetings and after all six group meetings. The THI and TRQ will serve as the primary outcome measures and will be administered before the first group meeting, after the sixth group meeting at 8 and 24 weeks post-treatment follow-up. Results of this pilot project will be used to inform the design and methods of a future rigorous randomized controlled clinical trial of CBT for tinnitus.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All subjects will be veterans who are currently receiving care at VACHS.
  • Subjects must be interested in participating in the study and have moderate to severe, chronic (>6 months) tinnitus.

    • Following a brief assessment of tinnitus severity by the project coordinator, the research otologist and research audiologist will conduct tinnitus and audiological evaluations to determine subject eligibility.
    • The most likely etiology of subjects' tinnitus must be noise exposure to be included in the study and all eligible subjects will report having been exposed to loud sound some time in their lives.
  • Subjects must indicate that they are 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 must have stable, permanent housing and transportation means for follow-up appointments.
  • Tinnitus will be a significant health concern for all subjects.
  • Women and minorities will be recruited.

Exclusion Criteria:

  • Subjects will respond to five assessment measures to determine exclusion from the study.

    • Tinnitus-Impact Screening Interview (TISI): Those who score 4 or lower will be excluded from the study.
    • Semi-Structured Clinical Interview for Tinnitus: The exclusionary criteria described below will be assessed using this measure.
    • Structured Clinical Interview for Diagnosis, abbreviated - Interview/Non-patient (SCIDa-I/NP): If there is any indication of psychosis on this measure, the subject will be excluded from the study.
    • Tinnitus Handicap Inventory (THI): Subjects with scores of 19 or lower will be excluded.
    • Tinnitus Reaction Questionnaire (TRQ): Subjects who score 16 or lower on this measure will be excluded from the study.
  • Subjects who are undergoing litigation or legal matters related to auditory disorders will be excluded from the study.
  • Subjects must never have previously received psychological treatment for their tinnitus.
  • Subjects who report having a history of traumatic brain injury (TBI) with loss of consciousness (LOC) will be excluded from the study.
  • Subjects with otherwise treatable tinnitus will be excluded.
  • Subjects who have a history of psychotic disorders or dementia will be excluded.
  • These psychotic symptoms will constitute 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 will be excluded.
  • Subjects who use hearing aids will be excluded from the study.
  • Subjects who present with sudden or fluctuating hearing loss will be excluded.
  • Subjects with tinnitus associated with otologic disease (e.g., Meniere's Disease) or other co-occurring diseases affecting vestibular dysfunction will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724152

Locations
United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Robert D. Kerns, PhD VA Connecticut Health Care System (West Haven)
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00724152     History of Changes
Other Study ID Numbers: C6324-P
Study First Received: July 23, 2008
Last Updated: July 2, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
coping skills
psychology
audiology
veterans
tinnitus
adult
intervention studies
tinnitus, noise induced
noise
auditory perception

Additional relevant MeSH terms:
Tinnitus
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014