Trial Outcomes & Findings for Cognitive Behavioral Therapy (CBT) for Tinnitus (NCT NCT00724152)
NCT ID: NCT00724152
Last Updated: 2015-05-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
33 participants
Primary outcome timeframe
pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks after session 1)
Results posted on
2015-05-06
Participant Flow
Participant milestones
| Measure |
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, epidemiological information, basic anatomy of the ear and brain, and support resources.
|
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.
|
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.
|
|---|---|---|---|
|
Two-arm Study Period
STARTED
|
14
|
11
|
0
|
|
Two-arm Study Period
COMPLETED
|
11
|
9
|
0
|
|
Two-arm Study Period
NOT COMPLETED
|
3
|
2
|
0
|
|
Three-arm Study Period (+Standard Care)
STARTED
|
4
|
2
|
2
|
|
Three-arm Study Period (+Standard Care)
COMPLETED
|
3
|
0
|
1
|
|
Three-arm Study Period (+Standard Care)
NOT COMPLETED
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
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, epidemiological information, basic anatomy of the ear and brain, and support resources.
|
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.
|
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.
|
|---|---|---|---|
|
Two-arm Study Period
Withdrawal by Subject
|
3
|
2
|
0
|
|
Three-arm Study Period (+Standard Care)
Withdrawal by Subject
|
1
|
2
|
1
|
Baseline Characteristics
Cognitive Behavioral Therapy (CBT) for Tinnitus
Baseline characteristics by cohort
| Measure |
Period 1: Arm 1/Cognitive Behavioral Therapy
n=11 Participants
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.
|
Period 1: Arm 2/Tinnitus Education
n=9 Participants
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.
|
Period 2: Arm 1/Cognitive Behavioral Therapy
n=3 Participants
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.
|
Period 2: 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. 3 group randomization.
|
Period 2: Arm 3/Standard Care
n=1 Participants
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
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
63 years
STANDARD_DEVIATION 19.5 • n=5 Participants
|
—
|
60 years
STANDARD_DEVIATION 0 • n=21 Participants
|
64 years
STANDARD_DEVIATION 9.7 • n=8 Participants
|
|
Gender
Female
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
|
Gender
Male
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
3 participants
n=5 Participants
|
—
|
1 participants
n=21 Participants
|
24 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
3 participants
n=5 Participants
|
—
|
1 participants
n=21 Participants
|
19 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
0 participants
n=21 Participants
|
3 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Latino
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
—
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
|
Tinnitus Handicap Inventory
|
44.1 units on a scale
STANDARD_DEVIATION 20.2 • n=5 Participants
|
55.1 units on a scale
STANDARD_DEVIATION 13.9 • n=7 Participants
|
40.7 units on a scale
STANDARD_DEVIATION 19.6 • n=5 Participants
|
—
|
30.0 units on a scale
STANDARD_DEVIATION 0 • n=21 Participants
|
49.1 units on a scale
STANDARD_DEVIATION 18.1 • n=8 Participants
|
PRIMARY outcome
Timeframe: pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks after session 1)Population: Period 1 and Period 2
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.
Outcome measures
| Measure |
Period 1: Arm 1/Cognitive Behavioral Therapy
n=11 Participants
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.
|
Period 1: Arm 2/Tinnitus Education
n=9 Participants
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.
|
Period 2: Arm 1/Cognitive Behavioral Therapy
n=3 Participants
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.
|
Period 2: 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. 3 group randomization.
|
Period 2: Arm 3/Standard Care
n=1 Participants
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.
|
|---|---|---|---|---|---|
|
Tinnitus Handicap Inventory (THI)
|
37.9 units on a scale of 0-100
Standard Deviation 16.9
|
45.1 units on a scale of 0-100
Standard Deviation 20.0
|
42.67 units on a scale of 0-100
Standard Deviation 23.2
|
—
|
26.0 units on a scale of 0-100
Standard Deviation 0
|
SECONDARY outcome
Timeframe: pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks later)Population: Period 1 and Period 2
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.
Outcome measures
| Measure |
Period 1: Arm 1/Cognitive Behavioral Therapy
n=11 Participants
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.
|
Period 1: Arm 2/Tinnitus Education
n=9 Participants
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.
|
Period 2: Arm 1/Cognitive Behavioral Therapy
n=3 Participants
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.
|
Period 2: 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. 3 group randomization.
|
Period 2: Arm 3/Standard Care
n=1 Participants
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.
|
|---|---|---|---|---|---|
|
Tinnitus Reaction Questionnaire (TRQ)
|
24.3 units on a scale ranging 0-104
Standard Deviation 21.6
|
31.2 units on a scale ranging 0-104
Standard Deviation 16.7
|
29.3 units on a scale ranging 0-104
Standard Deviation 11.4
|
—
|
15.0 units on a scale ranging 0-104
Standard Deviation 0
|
Adverse Events
Arm 1/Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2/Tinnitus Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3/Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Caroline Schmidt, Co-investigator
VA Connecticut Healthcare System
Phone: 203-932-5711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place