Cognitive Behavioral Therapy (CBT) for Tinnitus
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|ClinicalTrials.gov Identifier: NCT00724152|
Recruitment Status : Completed
First Posted : July 29, 2008
Results First Posted : April 17, 2015
Last Update Posted : May 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Behavioral: Cognitive Behavioral Therapy Behavioral: Tinnitus Education||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Cognitive-behavioral Therapy for Tinnitus|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
Experimental: Arm 1/Cognitive Behavioral Therapy
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.
Behavioral: Cognitive Behavioral Therapy
A psychotherapeutic approach to tinnitus management which includes tinnitus education
Other Name: CBT
Active Comparator: Arm 2/Tinnitus Education
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.
Behavioral: Tinnitus Education
An audiologic rehabilitative approach to tinnitus education.
No Intervention: Arm 3/Standard Care
Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment.
- 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.
- Tinnitus Reaction Questionnaire (TRQ) [ Time Frame: pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks later) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724152
|United States, Connecticut|
|VA Connecticut Health Care System (West Haven)|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Robert D. Kerns, PhD||VA Connecticut Health Care System (West Haven)|