Trial Outcomes & Findings for Internet-based Cognitive Behavioral Therapy for Tinnitus Sufferers (NCT NCT04335812)
NCT ID: NCT04335812
Last Updated: 2021-07-16
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
135 participants
T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-intervention
2021-07-16
Participant Flow
135 participants completed the informed consent 9 participants were excluded (5 outside the country and 4 were no longer interested) 126 participants were included in the study
Participant milestones
| Measure |
R-ICBT
The intervention offered is a guided relaxation-based CBT offered via the Internet. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules provided will focus on applied relaxation only.
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.
|
F-ICBT
The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules are a mixture of applied relaxation, Cognitive Behavioral Therapy and advice addressing common problems
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.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
63
|
|
Overall Study
COMPLETED
|
28
|
30
|
|
Overall Study
NOT COMPLETED
|
35
|
33
|
Reasons for withdrawal
| Measure |
R-ICBT
The intervention offered is a guided relaxation-based CBT offered via the Internet. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules provided will focus on applied relaxation only.
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.
|
F-ICBT
The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules are a mixture of applied relaxation, Cognitive Behavioral Therapy and advice addressing common problems
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
12
|
12
|
|
Overall Study
Did not engage in the intervention
|
22
|
18
|
Baseline Characteristics
Internet-based Cognitive Behavioral Therapy for Tinnitus Sufferers
Baseline characteristics by cohort
| Measure |
R-CBT
n=63 Participants
The intervention offered is a guided relaxation-based CBT offered via the Internet. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules provided will focus on applied relaxation only.
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.
|
F-ICBT
n=63 Participants
The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules are a mixture of applied relaxation, Cognitive Behavioral Therapy and advice addressing common problems
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.
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 13 • n=93 Participants
|
55 years
STANDARD_DEVIATION 13 • n=4 Participants
|
56 years
STANDARD_DEVIATION 13 • n=27 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
59 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
118 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=93 Participants
|
56 Participants
n=4 Participants
|
114 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=93 Participants
|
63 participants
n=4 Participants
|
126 participants
n=27 Participants
|
|
Tinnitus Functional Index (TFI)
|
50.52 score on a scale
STANDARD_DEVIATION 26.65 • n=93 Participants
|
48.70 score on a scale
STANDARD_DEVIATION 25.51 • n=4 Participants
|
49.61 score on a scale
STANDARD_DEVIATION 26 • n=27 Participants
|
PRIMARY outcome
Timeframe: T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-interventionPopulation: 63 participants started the trial in both the R-ICBT (applied relaxation) and F-ICBT (full ICBT) groups 28 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure 29 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure after both groups completed full ICBT 23 participants from the R-ICBTgroup and 19 from the ICBT group completed the 2-month post-intervention measure
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 |
R-ICBT
n=63 Participants
The intervention offered is a guided relaxation-based CBT offered via the Internet. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules provided will focus on applied relaxation only.
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.
|
F-ICBT
n=63 Participants
The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules are a mixture of applied relaxation, Cognitive Behavioral Therapy and advice addressing common problems
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.
|
|---|---|---|
|
Tinnitus Functional Index (TFI); Measure of Tinnitus Distress
T0: Baseline
|
48.7 score on a scale
Standard Deviation 25.51
|
50.52 score on a scale
Standard Deviation 26.65
|
|
Tinnitus Functional Index (TFI); Measure of Tinnitus Distress
T1: Post-intervention 1
|
32.13 score on a scale
Standard Deviation 21.38
|
28.95 score on a scale
Standard Deviation 20.75
|
|
Tinnitus Functional Index (TFI); Measure of Tinnitus Distress
T2: Post-intervention 2 (both completed full ICBT)
|
30.66 score on a scale
Standard Deviation 23.45
|
28.95 score on a scale
Standard Deviation 20.75
|
|
Tinnitus Functional Index (TFI); Measure of Tinnitus Distress
T3: 2-month post-intervention
|
23.81 score on a scale
Standard Deviation 9.87
|
27.16 score on a scale
Standard Deviation 20.78
|
SECONDARY outcome
Timeframe: T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-interventionPopulation: 63 participants started the trial in both the R-ICBT (applied relaxation) and F-ICBT (full ICBT) groups 28 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure 29 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure after both groups completed full ICBT 23 participants from the R-ICBTgroup and 19 from the ICBT group completed the 2-month post-intervention measure
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 |
R-ICBT
n=63 Participants
The intervention offered is a guided relaxation-based CBT offered via the Internet. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules provided will focus on applied relaxation only.
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.
|
F-ICBT
n=63 Participants
The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules are a mixture of applied relaxation, Cognitive Behavioral Therapy and advice addressing common problems
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.
|
|---|---|---|
|
Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition
T0: Baseline
|
44.67 score on a scale
Standard Deviation 20.43
|
42.52 score on a scale
Standard Deviation 18.58
|
|
Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition
T1: Post-intervention 1
|
30.96 score on a scale
Standard Deviation 20.03
|
27.26 score on a scale
Standard Deviation 20.17
|
|
Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition
T2: Post-intervention 2 (both completed full ICBT)
|
28.93 score on a scale
Standard Deviation 17.81
|
27.26 score on a scale
Standard Deviation 20.17
|
|
Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition
T3: 2-month post-intervention
|
25.30 score on a scale
Standard Deviation 15.84
|
23.07 score on a scale
Standard Deviation 17.54
|
SECONDARY outcome
Timeframe: T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-interventionPopulation: 63 participants started the trial in both the R-ICBT (applied relaxation) and F-ICBT (full ICBT) groups 28 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure 29 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure after both groups completed full ICBT 23 participants from the R-ICBTgroup and 19 from the ICBT group completed the 2-month post-intervention measure
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 |
R-ICBT
n=63 Participants
The intervention offered is a guided relaxation-based CBT offered via the Internet. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules provided will focus on applied relaxation only.
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.
|
F-ICBT
n=63 Participants
The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules are a mixture of applied relaxation, Cognitive Behavioral Therapy and advice addressing common problems
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.
|
|---|---|---|
|
Patient Health Questionnaire (PHQ-9); Measure of Depression
T0: Baseline
|
9.17 score on a scale
Standard Deviation 7.12
|
9.10 score on a scale
Standard Deviation 7.14
|
|
Patient Health Questionnaire (PHQ-9); Measure of Depression
T1: Post-intervention 1
|
4.96 score on a scale
Standard Deviation 5.07
|
4.32 score on a scale
Standard Deviation 3.95
|
|
Patient Health Questionnaire (PHQ-9); Measure of Depression
T2: Post-intervention 2 (both completed full ICBT)
|
5.04 score on a scale
Standard Deviation 5.7
|
4.32 score on a scale
Standard Deviation 3.95
|
|
Patient Health Questionnaire (PHQ-9); Measure of Depression
T3: 2-month post-intervention
|
3.35 score on a scale
Standard Deviation 4.17
|
4.12 score on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-interventionPopulation: 63 participants started the trial in both the R-ICBT (applied relaxation) and F-ICBT (full ICBT) groups 28 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure 29 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure after both groups completed full ICBT 23 participants from the R-ICBTgroup and 19 from the ICBT group completed the 2-month post-intervention measure
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 |
R-ICBT
n=63 Participants
The intervention offered is a guided relaxation-based CBT offered via the Internet. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules provided will focus on applied relaxation only.
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.
|
F-ICBT
n=63 Participants
The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules are a mixture of applied relaxation, Cognitive Behavioral Therapy and advice addressing common problems
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.
|
|---|---|---|
|
Generalized Anxiety Disorder (GAD-7); Measure of Anxiety
T0: Baseline
|
7.75 score on a scale
Standard Deviation 6.77
|
9.19 score on a scale
Standard Deviation 6.39
|
|
Generalized Anxiety Disorder (GAD-7); Measure of Anxiety
T1: Post-intervention 1
|
5.21 score on a scale
Standard Deviation 5.62
|
4.48 score on a scale
Standard Deviation 4.17
|
|
Generalized Anxiety Disorder (GAD-7); Measure of Anxiety
T2: Post-intervention 2 (both completed full ICBT)
|
4.86 score on a scale
Standard Deviation 5.84
|
4.48 score on a scale
Standard Deviation 4.17
|
|
Generalized Anxiety Disorder (GAD-7); Measure of Anxiety
T3: 2-month post-intervention
|
3.70 score on a scale
Standard Deviation 3.88
|
4.68 score on a scale
Standard Deviation 4.75
|
SECONDARY outcome
Timeframe: T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-interventionPopulation: 63 participants started the trial in both the R-ICBT (applied relaxation) and F-ICBT (full ICBT) groups 28 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure 29 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure after both groups completed full ICBT 23 participants from the R-ICBTgroup and 19 from the ICBT group completed the 2-month post-intervention measure
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 |
R-ICBT
n=63 Participants
The intervention offered is a guided relaxation-based CBT offered via the Internet. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules provided will focus on applied relaxation only.
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.
|
F-ICBT
n=63 Participants
The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules are a mixture of applied relaxation, Cognitive Behavioral Therapy and advice addressing common problems
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.
|
|---|---|---|
|
Insomnia Severity Index (ISI); Measure of Insomnia
T0: Baseline
|
11.90 score on a scale
Standard Deviation 7.45
|
12.25 score on a scale
Standard Deviation 7.7
|
|
Insomnia Severity Index (ISI); Measure of Insomnia
T1: Post-intervention 1
|
8.93 score on a scale
Standard Deviation 6.5
|
7.46 score on a scale
Standard Deviation 5.8
|
|
Insomnia Severity Index (ISI); Measure of Insomnia
T2: Post-intervention 2 (both completed full ICBT)
|
8.43 score on a scale
Standard Deviation 5.93
|
7.46 score on a scale
Standard Deviation 5.8
|
|
Insomnia Severity Index (ISI); Measure of Insomnia
T3: 2-month post-intervention
|
7.13 score on a scale
Standard Deviation 5
|
6.33 score on a scale
Standard Deviation 6.08
|
SECONDARY outcome
Timeframe: T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-interventionPopulation: 63 participants started the trial in both the R-ICBT (applied relaxation) and F-ICBT (full ICBT) groups 28 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure 29 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure after both groups completed full ICBT 23 participants from the R-ICBTgroup and 19 from the ICBT group completed the 2-month post-intervention measure
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 |
R-ICBT
n=63 Participants
The intervention offered is a guided relaxation-based CBT offered via the Internet. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules provided will focus on applied relaxation only.
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.
|
F-ICBT
n=63 Participants
The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules are a mixture of applied relaxation, Cognitive Behavioral Therapy and advice addressing common problems
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.
|
|---|---|---|
|
EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life
T0: Baseline
|
72.59 score on a scale
Standard Deviation 17
|
75.43 score on a scale
Standard Deviation 15.92
|
|
EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life
T1: Post-intervention 1
|
79.71 score on a scale
Standard Deviation 12.14
|
78.15 score on a scale
Standard Deviation 17.51
|
|
EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life
T2: Post-intervention 2 (both completed full ICBT)
|
76.43 score on a scale
Standard Deviation 15.79
|
78.15 score on a scale
Standard Deviation 17.51
|
|
EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life
T3: 2-month post-intervention
|
78.22 score on a scale
Standard Deviation 11.29
|
85.87 score on a scale
Standard Deviation 6.91
|
SECONDARY outcome
Timeframe: T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-interventionPopulation: 63 participants started the trial in both the R-ICBT (applied relaxation) and F-ICBT (full ICBT) groups 28 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure 29 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure after both groups completed full ICBT 23 participants from the R-ICBTgroup and 19 from the ICBT group completed the 2-month post-intervention measure
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 |
R-ICBT
n=63 Participants
The intervention offered is a guided relaxation-based CBT offered via the Internet. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules provided will focus on applied relaxation only.
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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F-ICBT
n=63 Participants
The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules are a mixture of applied relaxation, Cognitive Behavioral Therapy and advice addressing common problems
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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5.79 score on a scale
Standard Deviation 4.55
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6.29 score on a scale
Standard Deviation 5.70
|
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Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem
T1: Post-intervention 1
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3.21 score on a scale
Standard Deviation 3.32
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2.85 score on a scale
Standard Deviation 2.66
|
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Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem
T2: Post-intervention 2 (both completed full ICBT)
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3.36 score on a scale
Standard Deviation 3.68
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2.85 score on a scale
Standard Deviation 2.66
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Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem
T3: 2-month post-intervention
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2.78 score on a scale
Standard Deviation 3.19
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2.07 score on a scale
Standard Deviation 2.12
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SECONDARY outcome
Timeframe: T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-interventionPopulation: 63 participants started the trial in both the R-ICBT (applied relaxation) and F-ICBT (full ICBT) groups 28 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure 29 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure after both groups completed full ICBT 23 participants from the R-ICBTgroup and 19 from the ICBT group completed the 2-month post-intervention measure
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 |
R-ICBT
n=63 Participants
The intervention offered is a guided relaxation-based CBT offered via the Internet. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules provided will focus on applied relaxation only.
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.
|
F-ICBT
n=63 Participants
The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules are a mixture of applied relaxation, Cognitive Behavioral Therapy and advice addressing common problems
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.
|
|---|---|---|
|
Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem
T0: Baseline
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6.19 score on a scale
Standard Deviation 4.84
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5.94 score on a scale
Standard Deviation 5.06
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Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem
T1: Post-intervention 1
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3.75 score on a scale
Standard Deviation 3.7
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4.59 score on a scale
Standard Deviation 4.01
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Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem
T2: Post-intervention 2 (both completed full ICBT)
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4.71 score on a scale
Standard Deviation 4.32
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4.59 score on a scale
Standard Deviation 4.01
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Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem
T3: 2-month post-intervention
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4.65 score on a scale
Standard Deviation 3.59
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3.13 score on a scale
Standard Deviation 2.36
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SECONDARY outcome
Timeframe: T0: Baseline, T1: Post-intervention 1 (after both group complete initial intervention), T2: Post-intervention 2 (after R-ICBT group complete Full ICBT), T3: 2-months post-interventionPopulation: 63 participants started the trial in both the R-ICBT (applied relaxation) and F-ICBT (full ICBT) groups 28 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure 29 participants from the R-ICBT and 30 from the ICBT completed the post-intervention measure after both groups completed full ICBT 23 participants from the R-ICBTgroup and 19 from the ICBT group completed the 2-month post-intervention measure
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 |
R-ICBT
n=63 Participants
The intervention offered is a guided relaxation-based CBT offered via the Internet. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules provided will focus on applied relaxation only.
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.
|
F-ICBT
n=63 Participants
The intervention offered is a guided Internet-based CBT intervention. The intervention is similar to a self-help program, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is a 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice the techniques learned. The modules are a mixture of applied relaxation, Cognitive Behavioral Therapy and advice addressing common problems
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.
|
|---|---|---|
|
Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance
T0: Baseline
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1.17 score on a scale
Standard Deviation 1.4
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1.22 score on a scale
Standard Deviation 1.3
|
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Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance
T1: Post-intervention 1
|
1.0 score on a scale
Standard Deviation 1.39
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0.67 score on a scale
Standard Deviation 1.07
|
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Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance
T2: Post-intervention 2 (both completed full ICBT)
|
.96 score on a scale
Standard Deviation 1.3
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.67 score on a scale
Standard Deviation 1.07
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Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance
T3: 2-month post-intervention
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0.91 score on a scale
Standard Deviation 1.08
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0.47 score on a scale
Standard Deviation 0.74
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Adverse Events
R-ICBT
F-ICBT
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