Trial Outcomes & Findings for A CBT-based Internet Intervention for Adults With Tinnitus in the United Kingdom (NCT NCT02370810)
NCT ID: NCT02370810
Last Updated: 2021-07-14
Results Overview
Measure of how severe the tinnitus is Units of measurement: scores on a scale Abbreviation TFI Minimal value: 0 Maximum value 100 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
146 participants
Primary outcome timeframe
Assessed at baseline and 8 weeks post-intervention
Results posted on
2021-07-14
Participant Flow
Participant milestones
| Measure |
Experimental Group
CBT-based internet-intervention for tinnitus The intervention offered was a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It was an 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.
|
Control Group
During the active intervention phase the control group completed weekly measures and commenced the treatment once the experimental group completed the intervention (delayed treatment) paradigm
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|---|---|---|
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Overall Study
STARTED
|
73
|
73
|
|
Overall Study
COMPLETED
|
50
|
54
|
|
Overall Study
NOT COMPLETED
|
23
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Group
n=73 Participants
CBT-based internet-intervention for tinnitus 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 given to practice techniques learnt.
CBT-based internet-intervention for tinnitus: 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 given to practice techniques learnt.
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Weekly check-in Group
n=73 Participants
will complete weekly measures and commence the treatment once the experimental group completes the intervention
|
Total
n=146 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
56.82 years
STANDARD_DEVIATION 12.15 • n=73 Participants
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54.31 years
STANDARD_DEVIATION 13.50 • n=73 Participants
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55.57 years
STANDARD_DEVIATION 12.86 • n=146 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=73 Participants
|
40 Participants
n=73 Participants
|
70 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=73 Participants
|
33 Participants
n=73 Participants
|
76 Participants
n=146 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
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0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Tinnitus Severity at baseline
|
59.8 Score on a scale (0-100)
STANDARD_DEVIATION 18.0 • n=73 Participants
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59.2 Score on a scale (0-100)
STANDARD_DEVIATION 19.0 • n=73 Participants
|
59.5 Score on a scale (0-100)
STANDARD_DEVIATION 18.4 • n=146 Participants
|
PRIMARY outcome
Timeframe: Assessed at baseline and 8 weeks post-interventionPopulation: Intention to treat paradigm
Measure of how severe the tinnitus is Units of measurement: scores on a scale Abbreviation TFI Minimal value: 0 Maximum value 100 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales
Outcome measures
| Measure |
Experimental Group
n=73 Participants
CBT-based internet-intervention for tinnitus The intervention offered was a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It was an 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.
|
Control Group
n=73 Participants
During the active intervention phase the control group completed weekly measures and commenced the treatment once the experimental group completed the intervention (delayed treatment) paradigm
|
|---|---|---|
|
The Tinnitus Functional Index
Baseline score
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59.79 score on a scale
Standard Deviation 17.95
|
59.18 score on a scale
Standard Deviation 18.96
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|
The Tinnitus Functional Index
8 weeks Post treatment score
|
38.67 score on a scale
Standard Deviation 24.26
|
53.72 score on a scale
Standard Deviation 19.38
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SECONDARY outcome
Timeframe: Assessed at baseline and 8 weeks post-interventionPopulation: Intention to treat analysis
Measure of tinnitus severity to use as a weekly measure Measure of how severe the tinnitus is Units of measurement: scores on a scale Abbreviation THI-S Minimal value: 0 Maximum value 40 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales
Outcome measures
| Measure |
Experimental Group
n=73 Participants
CBT-based internet-intervention for tinnitus The intervention offered was a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It was an 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.
|
Control Group
n=73 Participants
During the active intervention phase the control group completed weekly measures and commenced the treatment once the experimental group completed the intervention (delayed treatment) paradigm
|
|---|---|---|
|
Tinnitus Handicap Inventory-screening Version
Baseline
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22.88 score on a scale
Standard Deviation 8.23
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23.48 score on a scale
Standard Deviation 8.86
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|
Tinnitus Handicap Inventory-screening Version
8 weeks Post-intervention
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14.22 score on a scale
Standard Deviation 10.79
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20.68 score on a scale
Standard Deviation 8.96
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SECONDARY outcome
Timeframe: Assessed at baseline and 8 weeks post-interventionPopulation: Intention to treat analysis
Measure of sleep problems Measure of how severe the tinnitus is Units of measurement: scores on a scale Abbreviation ISI Minimal value: 0 Maximum value 28 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales
Outcome measures
| Measure |
Experimental Group
n=73 Participants
CBT-based internet-intervention for tinnitus The intervention offered was a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It was an 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.
|
Control Group
n=73 Participants
During the active intervention phase the control group completed weekly measures and commenced the treatment once the experimental group completed the intervention (delayed treatment) paradigm
|
|---|---|---|
|
Insomnia Severity Index
Baseline
|
12.34 score on a scale
Standard Deviation 6.9
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13.52 score on a scale
Standard Deviation 7.16
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Insomnia Severity Index
8 weeks Post-intervention
|
8.6 score on a scale
Standard Deviation 6.83
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12.44 score on a scale
Standard Deviation 7.21
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SECONDARY outcome
Timeframe: Assessed at baseline and 8 weeks post-interventionPopulation: Intention to treat analysis
Measure of how cognitive difficulties such as concentration and memory Units of measurement: scores on a scale Minimal value: 0 Maximum value 100 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales
Outcome measures
| Measure |
Experimental Group
n=73 Participants
CBT-based internet-intervention for tinnitus The intervention offered was a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It was an 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.
|
Control Group
n=73 Participants
During the active intervention phase the control group completed weekly measures and commenced the treatment once the experimental group completed the intervention (delayed treatment) paradigm
|
|---|---|---|
|
Cognitive Failures Questionnaire
Baseline score
|
38.05 score on a scale
Standard Deviation 16.67
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44.52 score on a scale
Standard Deviation 18.34
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Cognitive Failures Questionnaire
8 weeks post intervention score
|
39.97 score on a scale
Standard Deviation 15.34
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41.3 score on a scale
Standard Deviation 16.73
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SECONDARY outcome
Timeframe: Assessed at baseline and 8 weeks post-interventionPopulation: Intention to treat
Quality of life measure Units of measurement: scores on a scale Minimal value: 5 Maximum value 35 Higher score is a better outcome Units are scores on a scale Total score used, not sub scales
Outcome measures
| Measure |
Experimental Group
n=73 Participants
CBT-based internet-intervention for tinnitus The intervention offered was a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It was an 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.
|
Control Group
n=73 Participants
During the active intervention phase the control group completed weekly measures and commenced the treatment once the experimental group completed the intervention (delayed treatment) paradigm
|
|---|---|---|
|
Satisfaction With Life
8 weeks Post-intervention
|
18.34 score on a scale
Standard Deviation 6.73
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16.17 score on a scale
Standard Deviation 6.29
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|
Satisfaction With Life
Baseline Score
|
16.77 score on a scale
Standard Deviation 6.31
|
16.38 score on a scale
Standard Deviation 6.03
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SECONDARY outcome
Timeframe: Assessed at baseline and 8 weeks post-interventionPopulation: Intention to treat
Measure of signs of depressive disorders Units of measurement: scores on a scale Minimal value: 0 Maximum value 28 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales
Outcome measures
| Measure |
Experimental Group
n=73 Participants
CBT-based internet-intervention for tinnitus The intervention offered was a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It was an 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.
|
Control Group
n=73 Participants
During the active intervention phase the control group completed weekly measures and commenced the treatment once the experimental group completed the intervention (delayed treatment) paradigm
|
|---|---|---|
|
Patient Health Questionnaire
8 weeks Post-intervention
|
5.89 score on a scale
Standard Deviation 6.13
|
7.75 score on a scale
Standard Deviation 5.22
|
|
Patient Health Questionnaire
Baseline
|
7.88 score on a scale
Standard Deviation 5.56
|
8.11 score on a scale
Standard Deviation 5.92
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SECONDARY outcome
Timeframe: Assessed at baseline and 8 weeks post-interventionPopulation: intention to treat anlaysis
Measure of anxiety disorder and traits Units of measurement: scores on a scale Minimal value: 0 Maximum value 21 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales
Outcome measures
| Measure |
Experimental Group
n=73 Participants
CBT-based internet-intervention for tinnitus The intervention offered was a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It was an 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.
|
Control Group
n=73 Participants
During the active intervention phase the control group completed weekly measures and commenced the treatment once the experimental group completed the intervention (delayed treatment) paradigm
|
|---|---|---|
|
Generalised Anxiety Disorder
Post-intervention
|
5.50 score on a scale
Standard Deviation 5.21
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6.87 score on a scale
Standard Deviation 4.85
|
|
Generalised Anxiety Disorder
Baseline
|
7.58 score on a scale
Standard Deviation 5.51
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7.21 score on a scale
Standard Deviation 5.64
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SECONDARY outcome
Timeframe: Assessed at baseline and 8 weeks post-interventionPopulation: Intention to treat analysis
Measure of abnormal sound sensitivity Units of measurement: scores on a scale Minimal value: 0 Maximum value 42 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales
Outcome measures
| Measure |
Experimental Group
n=73 Participants
CBT-based internet-intervention for tinnitus The intervention offered was a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It was an 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.
|
Control Group
n=73 Participants
During the active intervention phase the control group completed weekly measures and commenced the treatment once the experimental group completed the intervention (delayed treatment) paradigm
|
|---|---|---|
|
Hyperacusis Questionnaire
Post-intervention
|
16.30 score on a scale
Standard Deviation 9.9
|
19.49 score on a scale
Standard Deviation 9.78
|
|
Hyperacusis Questionnaire
Baseline
|
19.04 score on a scale
Standard Deviation 7.82
|
19.27 score on a scale
Standard Deviation 9.19
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SECONDARY outcome
Timeframe: Assessed at baseline and 8 weeks post-interventionPopulation: Intention to treat analysis
Measure of hearing difficulties or hearing disability using a screening tool Units of measurement: scores on a scale Minimal value: 0 Maximum value 40 Higher score is a worse outcome Units are scores on a scale Total score used, not sub scales
Outcome measures
| Measure |
Experimental Group
n=73 Participants
CBT-based internet-intervention for tinnitus The intervention offered was a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It was an 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.
|
Control Group
n=73 Participants
During the active intervention phase the control group completed weekly measures and commenced the treatment once the experimental group completed the intervention (delayed treatment) paradigm
|
|---|---|---|
|
Hearing Handicap Inventory- Screening Version
8 week sPost-intervention
|
15.31 score on a scale
Standard Deviation 12.13
|
17.90 score on a scale
Standard Deviation 10.47
|
|
Hearing Handicap Inventory- Screening Version
Baseline Score
|
17.26 score on a scale
Standard Deviation 11.71
|
18.44 score on a scale
Standard Deviation 11.06
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Adverse Events
Experimental Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Group
n=73 participants at risk
CBT-based internet-intervention for tinnitus The intervention offered was a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It was an 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.
|
Control Group
n=73 participants at risk
During the active intervention phase the control group completed weekly measures and commenced the treatment once the experimental group completed the intervention (delayed treatment) paradigm
|
|---|---|---|
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General disorders
Higher level of anxiety
|
0.00%
0/73 • 8 weeks post intervention and 1 year post intervention. Data collected: All-Cause Mortality: Deaths related to the study Serious Adverse Events: a severe increase in tinnitus distress; anxiety or depression related to the study Other Adverse Events: A severe increase in insomnia, hyperacusis or hearing handicap
All-Cause Mortality: Deaths related to the study Serious Adverse Events: a severe increase in tinnitus distress; anxiety or depression related to the study Other Adverse Events: A severe increase in insomnia, hyperacusis or hearing handicap
|
0.00%
0/73 • 8 weeks post intervention and 1 year post intervention. Data collected: All-Cause Mortality: Deaths related to the study Serious Adverse Events: a severe increase in tinnitus distress; anxiety or depression related to the study Other Adverse Events: A severe increase in insomnia, hyperacusis or hearing handicap
All-Cause Mortality: Deaths related to the study Serious Adverse Events: a severe increase in tinnitus distress; anxiety or depression related to the study Other Adverse Events: A severe increase in insomnia, hyperacusis or hearing handicap
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place