Trial Outcomes & Findings for Internet-based Versus Face-to-face Clinical Care for Tinnitus (NCT NCT02665975)

NCT ID: NCT02665975

Last Updated: 2021-07-14

Results Overview

A self-reported outcome measure of tinnitus severity. 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 out of 100 is reported and not any subscales Scores below 25 indicate mild tinnitus, from 25-50 indicated significant tinnitus and from 50-100 severe tinnitus

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 92 participants
• Primary outcome timeframe: At baseline and at 8 weeks post-intervention
• Results posted on: 2021-07-14

Participant Flow

Participant milestones

Measure	Experimental Group: iCBT 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: Tinnitus e-learning programme	Face-to-face Clinical Tinnitus Care Receive individual face-to-face tinnitus care, and follow-up appointments as required. Face-to-face clinical tinnitus care: Hospital tinnitus counselling
Overall Study STARTED	46	46
Overall Study COMPLETED	37	37
Overall Study NOT COMPLETED	9	9

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: iCBT n=46 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: Tinnitus e-learning programme	Face-to-face Clinical Tinnitus Care n=46 Participants Receive individual face-to-face tinnitus care, and follow-up appointments as required. Face-to-face clinical tinnitus care: Hospital tinnitus counselling	Total n=92 Participants Total of all reporting groups
Age, Continuous	50.65 years STANDARD_DEVIATION 12.19 • n=46 Participants	55.26 years STANDARD_DEVIATION 11.62 • n=46 Participants	52.96 years STANDARD_DEVIATION 12.07 • n=92 Participants
Sex: Female, Male Female	17 Participants n=46 Participants	20 Participants n=46 Participants	37 Participants n=92 Participants
Sex: Female, Male Male	29 Participants n=46 Participants	26 Participants n=46 Participants	55 Participants n=92 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Tinnitus Functional Index Score at Baseline	55.01 scores on a scale at baseline STANDARD_DEVIATION 21.58 • n=46 Participants	56.57 scores on a scale at baseline STANDARD_DEVIATION 20.61 • n=46 Participants	55.65 scores on a scale at baseline STANDARD_DEVIATION 21.01 • n=92 Participants

PRIMARY outcome

Timeframe: At baseline and at 8 weeks post-intervention

Population: Clinical population

A self-reported outcome measure of tinnitus severity. 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 out of 100 is reported and not any subscales Scores below 25 indicate mild tinnitus, from 25-50 indicated significant tinnitus and from 50-100 severe tinnitus

Outcome measures

Measure	Experimental Group: iCBT n=46 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: Tinnitus e-learning programme	Face-to-face Clinical Tinnitus Care n=46 Participants Receive individual face-to-face tinnitus care, and follow-up appointments as required. Face-to-face clinical tinnitus care: Hospital tinnitus counselling
The Tinnitus Functional Index 8 weeks post-intervention results	22.85 score on a scale Standard Deviation 19.26	32.51 score on a scale Standard Deviation 23.28
The Tinnitus Functional Index Baseline results	55.01 score on a scale Standard Deviation 21.58	55.26 score on a scale Standard Deviation 11.62

SECONDARY outcome

Timeframe: Assessed at baseline and 8 weeks post-intervention. Both time points are reported

Population: Clinical population

Measure of how severe the tinnitus is Units of measurement: scores on a scale Abbreviation THI Minimal value: 0 Maximum value 100 Higher score is a worse outcome Total score used, not sub scales

Outcome measures

Measure	Experimental Group: iCBT n=46 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: Tinnitus e-learning programme	Face-to-face Clinical Tinnitus Care n=46 Participants Receive individual face-to-face tinnitus care, and follow-up appointments as required. Face-to-face clinical tinnitus care: Hospital tinnitus counselling
Tinnitus Handicap Inventory 8 weeks post-intervention scores	17.78 score on a scale Standard Deviation 14.77	27.11 score on a scale Standard Deviation 21.62
Tinnitus Handicap Inventory Baseline scores	44.57 score on a scale Standard Deviation 23.40	47.13 score on a scale Standard Deviation 20.31

SECONDARY outcome

Timeframe: Assessed at baseline and 8 weeks post-intervention. Both scores are reported

Population: Clinical population

Quality of life measure Units of measurement: scores on a scale Minimal value: 5 Maximum value 35 Higher score is a better outcome

Total score used, not sub scales

Outcome measures

Measure	Experimental Group: iCBT n=46 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: Tinnitus e-learning programme	Face-to-face Clinical Tinnitus Care n=46 Participants Receive individual face-to-face tinnitus care, and follow-up appointments as required. Face-to-face clinical tinnitus care: Hospital tinnitus counselling
Satisfaction With Life Scale 8 weeks post-intervention socre	21.00 score on a scale Standard Deviation 5.05	20.50 score on a scale Standard Deviation 4.95
Satisfaction With Life Scale Baseline Score	18.7 score on a scale Standard Deviation 5.73	19.48 score on a scale Standard Deviation 5.54

SECONDARY outcome

Timeframe: Assessed at baseline and 8 weeks post-intervention

Population: clinical population

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: iCBT n=46 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: Tinnitus e-learning programme	Face-to-face Clinical Tinnitus Care n=46 Participants Receive individual face-to-face tinnitus care, and follow-up appointments as required. Face-to-face clinical tinnitus care: Hospital tinnitus counselling
Cognitive Failures Questionnaire 8 weeks post-intervention	30.06 score on a scale Standard Deviation 12.89	33.06 score on a scale Standard Deviation 19.24
Cognitive Failures Questionnaire Baseline score	34.93 score on a scale Standard Deviation 14.38	39.65 score on a scale Standard Deviation 19.31

SECONDARY outcome

Timeframe: At baseline and at 8 weeks post-intervention

Population: Clinical population

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 Total score used, not sub scales

Outcome measures

Measure	Experimental Group: iCBT n=46 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: Tinnitus e-learning programme	Face-to-face Clinical Tinnitus Care n=46 Participants Receive individual face-to-face tinnitus care, and follow-up appointments as required. Face-to-face clinical tinnitus care: Hospital tinnitus counselling
Patient Health Questionnaire Baseline score	6.5 score on a scale Standard Deviation 5.48	7.98 score on a scale Standard Deviation 6.05
Patient Health Questionnaire 8 weeks post-intervention	2.78 score on a scale Standard Deviation 3.02	4.97 score on a scale Standard Deviation 4.54

SECONDARY outcome

Timeframe: At baseline and at 8 weeks post-intervention. Both scores are reported

Population: Clinical population

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 Total score used, not sub scales

Outcome measures

Measure	Experimental Group: iCBT n=46 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: Tinnitus e-learning programme	Face-to-face Clinical Tinnitus Care n=46 Participants Receive individual face-to-face tinnitus care, and follow-up appointments as required. Face-to-face clinical tinnitus care: Hospital tinnitus counselling
Generalised Anxiety Disorder 8 weeks post-intervention	3.33 score on a scale Standard Deviation 3.21	3.42 score on a scale Standard Deviation 3.60
Generalised Anxiety Disorder baseline scores	6.43 score on a scale Standard Deviation 5.64	6.78 score on a scale Standard Deviation 5.54

SECONDARY outcome

Timeframe: At baseline and at 8 weeks post-intervention. both scores are reported

Population: Clinical population

Measure of abnormal sound sensitivity Units of measurement: scores on a scale Minimal value: 0 Maximum value 42 Hotal score used, not sub scales

Outcome measures

Measure	Experimental Group: iCBT n=46 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: Tinnitus e-learning programme	Face-to-face Clinical Tinnitus Care n=46 Participants Receive individual face-to-face tinnitus care, and follow-up appointments as required. Face-to-face clinical tinnitus care: Hospital tinnitus counselling
Hyperacusis Questionnaire 8 weeks post-intervention	12.51 score on a scale Standard Deviation 9.01	12.94 score on a scale Standard Deviation 7.51
Hyperacusis Questionnaire Baseline severity	15.65 score on a scale Standard Deviation 9.06	15.65 score on a scale Standard Deviation 7.42

SECONDARY outcome

Timeframe: At baseline and at 8 weeks post-intervention

Population: Clinical population

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 Total score used, not sub scales

Outcome measures

Measure	Experimental Group: iCBT n=46 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: Tinnitus e-learning programme	Face-to-face Clinical Tinnitus Care n=46 Participants Receive individual face-to-face tinnitus care, and follow-up appointments as required. Face-to-face clinical tinnitus care: Hospital tinnitus counselling
Hearing Handicap Inventory 8 weeks post-intervention	9.11 score on a scale Standard Error 11.59	12.00 score on a scale Standard Error 9.56
Hearing Handicap Inventory Baseline score	11.74 score on a scale Standard Error 10.66	14.3 score on a scale Standard Error 11.58

SECONDARY outcome

Timeframe: Assessed at baseline and 8 weeks post-intervention. both scores are reported

Population: Clinical population

Measure of sleep problems Units of measurement: scores on a scale Abbreviation ISI Minimal value: 0 Maximum value 28 Higher score is a worse outcome Total score used, not sub scales

Outcome measures

Measure	Experimental Group: iCBT n=46 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: Tinnitus e-learning programme	Face-to-face Clinical Tinnitus Care n=46 Participants Receive individual face-to-face tinnitus care, and follow-up appointments as required. Face-to-face clinical tinnitus care: Hospital tinnitus counselling
Insomnia Severity Index 8 weeks post-intervention	5.69 score on a scale Standard Deviation 4.64	10.03 score on a scale Standard Deviation 6.88
Insomnia Severity Index Baseline score	11.43 score on a scale Standard Deviation 6.36	13.65 score on a scale Standard Deviation 6.62

Adverse Events

Experimental Group: iCBT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Face-to-face Clinical Tinnitus 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

Eldre Beukes

Anglia Ruskin Univeristy

Phone: 01223698847

Email: eldre.beukes@anglia.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place