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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
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Tinnitus
Interventions Behavioral: Cognitive Behavioral Therapy
Behavioral: Tinnitus Education
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1/Cognitive Behavioral Therapy Arm 2/Tinnitus Education Arm 3/Standard Care
Hide Arm/Group 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, epidemiological information, basic anatomy of the ear and brain, and support resources.

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.
Period Title: Two-arm Study Period
Started 14 11 0 [1]
Completed 11 9 0
Not Completed 3 2 0
Reason Not Completed
Withdrawal by Subject             3             2             0
[1]
Standard Care arm was added later (Period 2)
Period Title: Three-arm Study Period (+Standard Care)
Started 4 2 2 [1]
Completed 3 0 1
Not Completed 1 2 1
Reason Not Completed
Withdrawal by Subject             1             2             1
[1]
3-group randomization began
Arm/Group Title Period 1: Arm 1/Cognitive Behavioral Therapy Period 1: Arm 2/Tinnitus Education Period 2: Arm 1/Cognitive Behavioral Therapy Period 2: Arm 2/Tinnitus Education Period 2: Arm 3/Standard Care Total
Hide Arm/Group 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, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 grp randomize. 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. 2 group randomization. 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, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 grp randomize. 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. 3 group randomization. Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. 3 group randomization. Total of all reporting groups
Overall Number of Baseline Participants 11 9 3 0 1 24
Hide Baseline Analysis Population Description
Period 1 and Period 2
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 9 participants 3 participants 0 participants 1 participants 24 participants
61.3  (9.6) 66.4  (9.5) 63  (19.5) 60  (0) 64  (9.7)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 3 participants 0 participants 1 participants 24 participants
Female 0 0 0 0 0
Male 11 9 3 1 24
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 3 participants 0 participants 1 participants 24 participants
Caucasian 8 7 3 1 19
African American 2 1 0 0 3
Latino 0 1 0 0 1
Mixed 1 0 0 0 1
Tinnitus Handicap Inventory   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants 9 participants 3 participants 0 participants 1 participants 24 participants
44.1  (20.2) 55.1  (13.9) 40.7  (19.6) 30.0  (0) 49.1  (18.1)
[1]
Measure Description: The THI score ranges from 0 to 100, with 100 indicating the most severe tinnitus and 0 is the least severe tinnitus.
1.Primary Outcome
Title Tinnitus Handicap Inventory (THI)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Period 1 and Period 2
Arm/Group Title Period 1: Arm 1/Cognitive Behavioral Therapy Period 1: Arm 2/Tinnitus Education Period 2: Arm 1/Cognitive Behavioral Therapy Period 2: Arm 2/Tinnitus Education Period 2: Arm 3/Standard Care
Hide Arm/Group 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, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 grp random.
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. 2 group randomization.
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, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 grp random.
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. 3 group randomization.
Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. 3 group randomization.
Overall Number of Participants Analyzed 11 9 3 0 1
Mean (Standard Deviation)
Unit of Measure: units on a scale of 0-100
37.9  (16.9) 45.1  (20.0) 42.67  (23.2) 26.0  (0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Period 1: Arm 1/Cognitive Behavioral Therapy, Period 1: Arm 2/Tinnitus Education
Comments Null hypothesis: The Cognitive Behavioral Therapy group would not demonstrate decreased distress at post-treatment as compared to the Tinnitus Education group on the primary outcome measure (THI) between pre-treatment and post-treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
2.Secondary Outcome
Title Tinnitus Reaction Questionnaire (TRQ)
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Period 1 and Period 2
Arm/Group Title Period 1: Arm 1/Cognitive Behavioral Therapy Period 1: Arm 2/Tinnitus Education Period 2: Arm 1/Cognitive Behavioral Therapy Period 2: Arm 2/Tinnitus Education Period 2: Arm 3/Standard Care
Hide Arm/Group 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, epidemiological information, basic anatomy of the ear and brain, and support resources. 2 grp random.
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. 2 group randomization.
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, epidemiological information, basic anatomy of the ear and brain, and support resources. 3 grp random.
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. 3 group randomization.
Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment. 3 group randomization.
Overall Number of Participants Analyzed 11 9 3 0 1
Mean (Standard Deviation)
Unit of Measure: units on a scale ranging 0-104
24.3  (21.6) 31.2  (16.7) 29.3  (11.4) 15.0  (0)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1/Cognitive Behavioral Therapy Arm 2/Tinnitus Education Arm 3/Standard Care
Hide Arm/Group 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, epidemiological information, basic anatomy of the ear and brain, and support resources.

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.

Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment.
All-Cause Mortality
Arm 1/Cognitive Behavioral Therapy Arm 2/Tinnitus Education Arm 3/Standard Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Arm 1/Cognitive Behavioral Therapy Arm 2/Tinnitus Education Arm 3/Standard Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/13 (0.00%)   0/2 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1/Cognitive Behavioral Therapy Arm 2/Tinnitus Education Arm 3/Standard Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/13 (0.00%)   0/2 (0.00%) 
During Period 2 only two participants (one completer) were randomized to "standard care" and only four participants (3 completers) were randomized "Cognitive Behavioral Therapy."
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Caroline Schmidt, Co-investigator
Organization: VA Connecticut Healthcare System
Phone: 203-932-5711 ext 3391
EMail: Caroline.Schmidt@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00724152    
Other Study ID Numbers: C6324-P
First Submitted: July 23, 2008
First Posted: July 29, 2008
Results First Submitted: January 6, 2015
Results First Posted: April 17, 2015
Last Update Posted: May 6, 2015