Trial Outcomes & Findings for Internet-based Cognitive Behavioural Therapy for Spanish Tinnitus Sufferers (NCT NCT04335929)
NCT ID: NCT04335929
Last Updated: 2021-08-06
Results Overview
Tinnitus Functional Index (TFI) is a 25-item questionnaire that evaluates the severity of tinnitus distress. Total possible score ranges from 0-to-100 with higher scores suggesting more severe tinnitus distress (i.e., worse outcome). Scores \>25 indicate tinnitus is a significant problem requiring tinnitus intervention.
COMPLETED
NA
46 participants
T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)
2021-08-06
Participant Flow
46 participants screened at baseline and completed informed consent 3 participants were excluded as they did not meet inclusion criteria 11 participants decided not to participate
Participant milestones
| Measure |
Internet-based Cognitive Behavior Therapy
The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
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Overall Study
STARTED
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32
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Overall Study
COMPLETED
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22
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Overall Study
NOT COMPLETED
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10
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Reasons for withdrawal
| Measure |
Internet-based Cognitive Behavior Therapy
The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
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Overall Study
Lost to Follow-up
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10
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Baseline Characteristics
Internet-based Cognitive Behavioural Therapy for Spanish Tinnitus Sufferers
Baseline characteristics by cohort
| Measure |
Internet-based Cognitive Behavior Therapy
n=32 Participants
The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
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Age, Continuous
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46.63 years
STANDARD_DEVIATION 11 • n=5 Participants
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Sex: Female, Male
Female
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17 Participants
n=5 Participants
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Sex: Female, Male
Male
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15 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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29 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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3 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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2 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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26 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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3 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
Spain
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17 participants
n=5 Participants
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Region of Enrollment
Ukraine
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2 participants
n=5 Participants
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Region of Enrollment
Puerto Rico
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2 participants
n=5 Participants
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Region of Enrollment
Germany
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1 participants
n=5 Participants
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Region of Enrollment
France
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1 participants
n=5 Participants
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Region of Enrollment
Brazil
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6 participants
n=5 Participants
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Region of Enrollment
Mexico
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2 participants
n=5 Participants
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Region of Enrollment
Costa Rica
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1 participants
n=5 Participants
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Tinnitus Functional Index (TFI); Measure of Tinnitus Distress
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61.06 score on a scale
STANDARD_DEVIATION 19.03 • n=5 Participants
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PRIMARY outcome
Timeframe: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)Population: 32 participants started the trial 22 participants completed the post-intervention measures 16 participants completed the 2-month post-intervention measures
Tinnitus Functional Index (TFI) is a 25-item questionnaire that evaluates the severity of tinnitus distress. Total possible score ranges from 0-to-100 with higher scores suggesting more severe tinnitus distress (i.e., worse outcome). Scores \>25 indicate tinnitus is a significant problem requiring tinnitus intervention.
Outcome measures
| Measure |
Internet-based Cognitive Behavior Therapy
n=32 Participants
The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
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Tinnitus Functional Index (TFI); Measure of Tinnitus Distress
Baseline
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61.06 score on a scale
Standard Deviation 19.03
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Tinnitus Functional Index (TFI); Measure of Tinnitus Distress
Post-intervention
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41.78 score on a scale
Standard Deviation 27.02
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Tinnitus Functional Index (TFI); Measure of Tinnitus Distress
2-months post-intervention
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40.38 score on a scale
Standard Deviation 26.65
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SECONDARY outcome
Timeframe: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)Population: 32 participants started the trial 22 participants completed the post-intervention measures 16 participants completed the 2-month post-intervention measures
Tinnitus Cognition Questionnaire (TCQ) is a 26-item questionnaire that assesses positive and negative cognitions associated with tinnitus. The first 13 items refer to negative thoughts and the second 13 items refer to positive thoughts. Responses are marked on a five-point Likert scale (0 to 4). The negative items (1-13) are scored 0-4, whereas the positive items (14-26) are reverse-scored: 4-0. The scoring procedure involves the simple addition of the number circled by the respondent for items 1-13 and the addition of reverse-scored items 14-26. The total score of the TCQ has a potential range from 0 to 104. A high score represents a greater tendency to engage in negative cognitions (i.e., worse outcome) in response to tinnitus and low engagement in positive cognitions.
Outcome measures
| Measure |
Internet-based Cognitive Behavior Therapy
n=32 Participants
The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
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Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition
T0: Baseline
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52.56 score on a scale
Standard Deviation 13.18
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Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition
T1: Post-intervention
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38.55 score on a scale
Standard Deviation 24.57
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Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition
T2: 2-month post-intervention
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37.06 score on a scale
Standard Deviation 23.53
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SECONDARY outcome
Timeframe: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)Population: 32 participants started the trial 22 participants completed the post-intervention measures 16 participants completed the 2-month post-intervention measures
Patient Health Questionnaire (PHQ-9) is a 9-item questionnaire that assesses depression severity. Responses are marked on a four-point Likert scale (0 to 3). The total score can range from 0 to 27 with higher scores indicating more severe depression (i.e., worse outcome).
Outcome measures
| Measure |
Internet-based Cognitive Behavior Therapy
n=32 Participants
The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
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Patient Health Questionnaire (PHQ-9); Measure of Depression
T0: Baseline
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11.25 score on a scale
Standard Deviation 7.02
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Patient Health Questionnaire (PHQ-9); Measure of Depression
T1: Post-intervention
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5.41 score on a scale
Standard Deviation 5.82
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Patient Health Questionnaire (PHQ-9); Measure of Depression
T2: 2-month post-intervention
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6.13 score on a scale
Standard Deviation 8.55
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SECONDARY outcome
Timeframe: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)Population: 32 participants started the trial 22 participants completed the post-intervention measures 16 participants completed the 2-month post-intervention measures
Generalized Anxiety Disorder (GAD-7) is a 7-item questionnaire that assesses the severity of anxiety. Responses are marked on a four-point Likert scale (0 to 3). The total score can range from 0 to 21 with higher scores indicating more severe anxiety (i.e., worse outcome).
Outcome measures
| Measure |
Internet-based Cognitive Behavior Therapy
n=32 Participants
The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
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Generalized Anxiety Disorder (GAD-7); Measure of Anxiety
T0: Baseline
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10.25 score on a scale
Standard Deviation 5.32
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Generalized Anxiety Disorder (GAD-7); Measure of Anxiety
T1: Post-intervention
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5.23 score on a scale
Standard Deviation 4.24
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Generalized Anxiety Disorder (GAD-7); Measure of Anxiety
T2: 2-month post-intervention
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5.62 score on a scale
Standard Deviation 5.4
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SECONDARY outcome
Timeframe: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)Population: 32 participants started the trial 22 participants completed the post-intervention measures 16 participants completed the 2-month post-intervention measures
Insomnia Severity Index (ISI) is a 7-item questionnaire that evaluates insomnia. Responses are marked on a five-point Likert scale (0 to 4). The total score can range from 0 to 28 with higher scores indicating more severe insomnia (i.w., worse outcome).
Outcome measures
| Measure |
Internet-based Cognitive Behavior Therapy
n=32 Participants
The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
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Insomnia Severity Index (ISI); Measure of Insomnia
T1: Post-intervention
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10.55 score on a scale
Standard Deviation 7.11
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Insomnia Severity Index (ISI); Measure of Insomnia
T2: 2-month post-intervention
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9.38 score on a scale
Standard Deviation 7.71
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Insomnia Severity Index (ISI); Measure of Insomnia
T0: Baseline
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14.97 score on a scale
Standard Deviation 6.6
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SECONDARY outcome
Timeframe: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)Population: 32 participants started the trial 22 participants completed the post-intervention measures 16 participants completed the 2-month post-intervention measures
EQ-5D-5L VAS is a single-item questionnaire that evaluates the health-related quality of life. Responses are marked on a 0-100 scale with higher scores indicating higher health-related quality o life (i.e., better outcome).
Outcome measures
| Measure |
Internet-based Cognitive Behavior Therapy
n=32 Participants
The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
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EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life
T0: Baseline
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67.03 score on a scale
Standard Deviation 16.94
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EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life
T1: Post-intervention
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73.64 score on a scale
Standard Deviation 14.65
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EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life
T2: 2-month post-intervention
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76.75 score on a scale
Standard Deviation 15.33
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SECONDARY outcome
Timeframe: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)Population: 32 participants started the trial 22 participants completed the post-intervention measures 16 participants completed the 2-month post-intervention measures
Tinnitus and Hearing Survey (THS) is a 10-item questionnaire that helps in determining how much of a patient's complaint about tinnitus is due to a hearing problem and how much is due specifically to the tinnitus. THS has three sections/subscales (A, B, and C). Section A consists of four items that address common tinnitus problems. Section B contains four items that address hearing. Section C, which includes two items, which focus on sound tolerance problem and ability to participate in group therapy. Responses for each item can range from 0 (not a problem) to 4 (very big problem). The total THS score can range from 0 to 40. However, the scores for this specific sub-scale can range from 0 to 16 with higher scores indicating more tinnitus problem (i.e., worse outcome).
Outcome measures
| Measure |
Internet-based Cognitive Behavior Therapy
n=32 Participants
The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
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Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem
T0: Baseline
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8.06 score on a scale
Standard Deviation 3.6
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Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem
T1: Post-intervention
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4.64 score on a scale
Standard Deviation 3.75
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Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem
T2: 2-months post-intervention
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4.44 score on a scale
Standard Deviation 4.35
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SECONDARY outcome
Timeframe: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)Population: 32 participants started the trial 22 participants completed the post-intervention measures 16 participants completed the 2-month post-intervention measures
Tinnitus and Hearing Survey (THS) is a 10-item questionnaire that helps in determining how much of a patient's complaint about tinnitus is due to a hearing problem and how much is due specifically to the tinnitus. THS has three sections/subscales (A, B, and C). Section A consists of four items that address common tinnitus problems. Section B contains four items that address hearing. Section C, which includes two items, which focus on sound tolerance problem and ability to participate in group therapy. Responses for each item can range from 0 (not a problem) to 4 (very big problem). The total THS score can range from 0 to 40. However, the scores for this specific sub-scale can range from 0 to 16 with higher scores indicating more hearing problem (i.e., worse outcome).
Outcome measures
| Measure |
Internet-based Cognitive Behavior Therapy
n=32 Participants
The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
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Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem
T0: Baseline
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5.34 score on a scale
Standard Deviation 4.29
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Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem
T1: Post-intervention
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5.55 score on a scale
Standard Deviation 4.06
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Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem
T2: 2-months post-intervention
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3.94 score on a scale
Standard Deviation 4.40
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SECONDARY outcome
Timeframe: T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)Population: 32 participants started the trial 22 participants completed the post-intervention measures 16 participants completed the 2-month post-intervention measures
Tinnitus and Hearing Survey (THS) is a 10-item questionnaire that helps in determining how much of a patient's complaint about tinnitus is due to a hearing problem and how much is due specifically to the tinnitus. THS has three sections/subscales (A, B, and C). Section A consists of four items that address common tinnitus problems. Section B contains four items that address hearing. Section C, which includes two items, which focus on sound tolerance problem and ability to participate in group therapy. Responses for each item can range from 0 (not a problem) to 4 (very big problem). The total THS score can range from 0 to 40. However, the scores for this specific sub-scale can range from 0 to 8 with higher scores indicating more sound tolerance problem (i.e., worse outcome).
Outcome measures
| Measure |
Internet-based Cognitive Behavior Therapy
n=32 Participants
The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
Internet-based Cognitive Behavior Therapy: The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
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Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance
T0: Baseline
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1.72 score on a scale
Standard Deviation 1.28
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Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance
T1: Post-intervention
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1.5 score on a scale
Standard Deviation 1.47
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Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance
T2: 2-months post-intervention
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1.13 score on a scale
Standard Deviation 1.09
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Adverse Events
Internet-based Cognitive Behavior Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Vinaya Manchaiah, Jo Mayo Endowed Professor
Lamar University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place