search
Back to results

Cognitive Behavioral Therapy (CBT) for Tinnitus

Primary Purpose

Tinnitus

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Tinnitus Education
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring coping skills, psychology, audiology, veterans, tinnitus, adult, intervention studies, tinnitus, noise induced, noise, auditory perception

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Connecticut Health Care System (West Haven)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Arm 1/Cognitive Behavioral Therapy

Arm 2/Tinnitus Education

Arm 3/Standard Care

Arm Description

Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included 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 and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, etc.

Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources.

Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment.

Outcomes

Primary Outcome Measures

Tinnitus Handicap Inventory (THI)
Most widely used measure of tinnitus distress available during study period. The THI was created using the Tinnitus Handicap Questionnaire and the Tinnitus Questionnaire as well as the Beck Depression Inventory and Modified Somatic Perception Questionnaire. Its construct validity was also assessed using patients' responses on symptom rating scales and auditory tests of pitch and loudness. The THI score ranges from 0 to 100, with 100 indicating the most severe tinnitus and 0 is the least severe tinnitus. The authors of the THI have designated levels of severity, with scores of 16 and below falling into the "no handicap" range. This measure has strong internal consistency reliability (Cronbach's alpha = .93) and test-retest validity for the total score (r = .92). Significant improvement in tinnitus handicap can be observed with a 20-point change in total score.

Secondary Outcome Measures

Tinnitus Reaction Questionnaire (TRQ)
This is another commonly used measure of tinnitus distress in research. The TRQ is a global measure of tinnitus distress and was developed using correlations with clinician and self-report ratings of symptom categories. Scores on this measure range from 0 to 104 with higher scores indicating more distress. This measure has a high internal consistency reliability (Cronbach's alpha = .96) and test-retest validity for the total score (r = .88). Scores of 17 points or higher on this measure will indicate tinnitus severity is such that the patient is significantly disturbed by tinnitus. This is based on the use of the TRQ as a pre-test measure in measuring outcome of a controlled trial of CBT for tinnitus in an elderly sample. That study sample had an average TRQ score of 16.9 prior to treatment.

Full Information

First Posted
July 23, 2008
Last Updated
April 16, 2015
Sponsor
US Department of Veterans Affairs
Collaborators
Yale University
search

1. Study Identification

Unique Protocol Identification Number
NCT00724152
Brief Title
Cognitive Behavioral Therapy (CBT) for Tinnitus
Official Title
Cognitive-behavioral Therapy for Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
coping skills, psychology, audiology, veterans, tinnitus, adult, intervention studies, tinnitus, noise induced, noise, auditory perception

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1/Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included 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 and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, etc.
Arm Title
Arm 2/Tinnitus Education
Arm Type
Active Comparator
Arm Description
Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources.
Arm Title
Arm 3/Standard Care
Arm Type
No Intervention
Arm Description
Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT
Intervention Description
A psychotherapeutic approach to tinnitus management which includes tinnitus education
Intervention Type
Behavioral
Intervention Name(s)
Tinnitus Education
Intervention Description
An audiologic rehabilitative approach to tinnitus education.
Primary Outcome Measure Information:
Title
Tinnitus Handicap Inventory (THI)
Description
Most widely used measure of tinnitus distress available during study period. The THI was created using the Tinnitus Handicap Questionnaire and the Tinnitus Questionnaire as well as the Beck Depression Inventory and Modified Somatic Perception Questionnaire. Its construct validity was also assessed using patients' responses on symptom rating scales and auditory tests of pitch and loudness. The THI score ranges from 0 to 100, with 100 indicating the most severe tinnitus and 0 is the least severe tinnitus. The authors of the THI have designated levels of severity, with scores of 16 and below falling into the "no handicap" range. This measure has strong internal consistency reliability (Cronbach's alpha = .93) and test-retest validity for the total score (r = .92). Significant improvement in tinnitus handicap can be observed with a 20-point change in total score.
Time Frame
pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks after session 1)
Secondary Outcome Measure Information:
Title
Tinnitus Reaction Questionnaire (TRQ)
Description
This is another commonly used measure of tinnitus distress in research. The TRQ is a global measure of tinnitus distress and was developed using correlations with clinician and self-report ratings of symptom categories. Scores on this measure range from 0 to 104 with higher scores indicating more distress. This measure has a high internal consistency reliability (Cronbach's alpha = .96) and test-retest validity for the total score (r = .88). Scores of 17 points or higher on this measure will indicate tinnitus severity is such that the patient is significantly disturbed by tinnitus. This is based on the use of the TRQ as a pre-test measure in measuring outcome of a controlled trial of CBT for tinnitus in an elderly sample. That study sample had an average TRQ score of 16.9 prior to treatment.
Time Frame
pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks later)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert D. Kerns, PhD
Organizational Affiliation
VA Connecticut Health Care System (West Haven)
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Health Care System (West Haven)
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cognitive Behavioral Therapy (CBT) for Tinnitus

We'll reach out to this number within 24 hrs