TinnitusPhase 1/2NCT00724152
Cognitive Behavioral Therapy (CBT) for Tinnitus
A Phase 1/2 study testing Cognitive Behavioral Therapy and Tinnitus Education in people with Tinnitus, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Cognitive Behavioral Therapy and Tinnitus Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Feb 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 29Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516
About this study
Official title: Cognitive-behavioral Therapy for Tinnitus
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.
Read the 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.
- Conditions
- Tinnitus
- Being tested
- Cognitive Behavioral Therapy, Tinnitus Education
- Keywords
- coping skills, psychology, audiology, veterans, tinnitus, adult, intervention studies, tinnitus, noise induced, noise, auditory perception
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called CBT
A psychotherapeutic approach to tinnitus management which includes tinnitus education
Tinnitus EducationBehavioural
An audiologic rehabilitative approach to tinnitus education.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1/Cognitive Behavioral Therapy | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy |
| Arm 2/Tinnitus Education | Active comparator | 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. Receives: Behavioral: Tinnitus Education |
| Arm 3/Standard Care | No intervention | Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks after session 1)
Secondary outcomes (1)
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.
Measured: pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Robert D. Kerns, PhD, Principal investigator, VA Connecticut Health Care System (West Haven)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724152
- Sponsor's protocol ID
- C6324-P
- Status last verified
- Apr 2015
- First submitted
- 23 Jul 2008
- Last updated
- 6 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-behavioral Therapy for Tinnitus
- ClinicalTrials.gov ID
- NCT00724152
- Acronym / sponsor ID
- C6324-P
- Conditions
- Tinnitus
- Keywords
- coping skills, psychology, audiology, veterans, tinnitus, adult, intervention studies, tinnitus, noise induced
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Yale University
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Posted 17 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1/Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyParticipants 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 2/Tinnitus Education | Active comparator | Behavioral: Tinnitus EducationParticipants 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 3/Standard Care | No intervention | –Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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.
Key exclusion criteria (29 listed)
- Subjects responded to five assessment measures to determine exclusion 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyAlso: CBTA psychotherapeutic approach to tinnitus management which includes tinnitus education | Behavioural | Arm 1/Cognitive Behavioral Therapy |
| Tinnitus EducationAn audiologic rehabilitative approach to tinnitus education. | Behavioural | Arm 2/Tinnitus Education |
Primary outcome
Tinnitus Handicap Inventory (THI)
Time frame: pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks after session 1)
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.
1 secondary outcome
Tinnitus Reaction Questionnaire (TRQ)
Time frame: pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks later)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Tinnitus
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Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
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Deep Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
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Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
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TNF-α Treatment of Blast-Induced Tinnitus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert D. Kerns, PhD principal investigator
VA Connecticut Health Care System (West Haven)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cognitive Behavioral Therapy and Tinnitus Education in people with Tinnitus, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Handicap Inventory (THI) (time frame: pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks after session 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2015.