ICBT: Internet-based Cognitive Behavioral Therapy for Tinnitus Sufferers
Sponsor
Lamar University (Other)
Overall Status
Completed
CT.gov ID
NCT04335812
Collaborator
(none)
135
1
2
2.7
50.7
Study Details
Study Description
Brief Summary
Nearly 50 million people in the U.S. experience tinnitus, of which about 20 million people have burdensome chronic tinnitus. Tinnitus can be very debilitating as many aspects of daily life can be affected, such as sleep, mood, and concentration. Currently, there is no cure for tinnitus. Pharmacological or sound-therapy based interventions are sometimes provided but may be of limited value to certain individuals. Research suggests that Cognitive Behavior Therapy (CBT) based approaches have the most evidence of effectiveness in the management of tinnitus. However, CBT is rarely offered to tinnitus sufferers in the U.S. (less than 1%), partly because of lack of trained professionals who can deliver CBT. To improve access to CBT for tinnitus, an online CBT program has been developed. The purpose of this study is to evaluate if the full CBT administered via the Internet results in better outcomes when compared to relaxation only CBT administered via the Internet for adults with tinnitus in the United States.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Objective: To examine the difference in outcomes of relaxation-based Internet-based cognitive behavioral therapy (R-ICBT) versus full version of Internet-based cognitive behavioral therapy (F-ICBT) for tinnitus sufferers.
Hypothesis: It is hypothesized that F-ICBT (experimental group) is superior when compared to R-ICBT (control group) in reducing the tinnitus-related distress, decreasing sleep disturbance, decreasing anxiety and depression, and improving health-related quality of life. The investigators also hypothesize that these results will be stable in both short- and long-term post-intervention.
Design: A two-armed Randomized Control Trial (RCT), with a one-year follow-up design will be used to evaluate the efficacy of F-ICBT and R-ICBT on tinnitus distress.
Setting: This will be an Internet-based study for adults with tinnitus living in the USA.
Participants: Eligible participants will include adults with tinnitus for a minimum period of 3 months with internet access and no major medical or psychiatric conditions. 100 participants will be recruited for each group and will be randomly assigned using a computer-generated randomization schedule by an independent research assistant after being pre-stratified for tinnitus severity and depression severity.
Intervention: The intervention offered to experimental group is a guided CTB-based internet intervention (ICBT), 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. The experimental group will be given the full ICBT program with all the components (22 chapters), whereas the control group will get only the relaxation-based exercises (8 chapters) of the ICBT program.
Outcome measures: The main outcome measure is the Tinnitus Functional Index (TFI). Secondary outcome measures are the Tinnitus and Hearing Survey (THS), Tinnitus Cognition Questionnaire (TCQ), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder (GAD-7), Insomnia Severity Index (ISI), and EuroQol EQ-5D-5L VAS.
Study Design
Study Type:
Interventional
Actual Enrollment
:
135 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Internet-based Cognitive Behavioral Therapy for Tinnitus Sufferers: Comparing the Full CBT Program With Relaxation Only Program
Actual Study Start Date
:
May 4, 2020
Actual Primary Completion Date
:
Jul 24, 2020
Actual Study Completion Date
:
Jul 24, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: 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.
Other Names:
|
| Active Comparator: 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 |
Behavioral: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Tinnitus Functional Index (TFI); Measure of Tinnitus Distress [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]
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.
Secondary Outcome Measures
- Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition [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]
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.
- Patient Health Questionnaire (PHQ-9); Measure of Depression [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]
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).
- Generalized Anxiety Disorder (GAD-7); Measure of Anxiety [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]
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).
- Insomnia Severity Index (ISI); Measure of Insomnia [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]
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).
- EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life [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]
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).
- Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem [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]
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).
- Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem [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]
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).
- Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance [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]
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).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
aged 18 years and older living in the USA;
-
the ability to read and type in English;
-
no barriers to using a computer (e.g. no significant fine motor control or visual problems);
-
Internet and e-mail access and the ability to use it;
-
commitment to completing the program;
-
completion of the online screening and outcome questionnaires;
-
agree to participate in either group and be randomized to one of these groups;
-
understand and work towards the end goal of reducing the impact and distress of tinnitus, although the strength of the tinnitus may remain the same;
-
be available for 12 months after starting the study to complete a 1-year follow-up questionnaire; and
-
experience bothersome tinnitus for a minimum period of 3 months;
Exclusion Criteria:
-
reporting any major medical or psychiatric conditions;
-
reporting pulsatile, objective or unilateral tinnitus, which has not been investigated medically;
-
tinnitus as a consequence of a medical disorder, still under investigation; and
-
undergoing any other tinnitus therapy while participating in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lamar University | Beaumont | Texas | United States | 77705 |
Sponsors and Collaborators
- Lamar University
Investigators
- Principal Investigator: Vinaya Manchaiah, PhD, Lamar University
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Vinaya Manchaiah,
Jo Mayo Endowed Professor,
Lamar University
ClinicalTrials.gov Identifier:
NCT04335812
Other Study ID Numbers:
- IRB-FY20-200-1
First Posted:
Apr 6, 2020
Last Update Posted:
Jul 16, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | R-ICBT | F-ICBT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 63 | 63 |
| COMPLETED | 28 | 30 |
| NOT COMPLETED | 35 | 33 |
Baseline Characteristics
| Arm/Group Title | R-CBT | F-ICBT | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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 of all reporting groups |
| Overall Participants | 63 | 63 | 126 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
57
(13)
|
55
(13)
|
56
(13)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
25
39.7%
|
37
58.7%
|
62
49.2%
|
| Male |
38
60.3%
|
26
41.3%
|
64
50.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
4
6.3%
|
4
6.3%
|
8
6.3%
|
| Not Hispanic or Latino |
59
93.7%
|
59
93.7%
|
118
93.7%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
1
1.6%
|
1
1.6%
|
2
1.6%
|
| Black or African American |
2
3.2%
|
3
4.8%
|
5
4%
|
| White |
58
92.1%
|
56
88.9%
|
114
90.5%
|
| More than one race |
2
3.2%
|
3
4.8%
|
5
4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
63
100%
|
63
100%
|
126
100%
|
| Tinnitus Functional Index (TFI) (score on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [score on a scale] |
50.52
(26.65)
|
48.70
(25.51)
|
49.61
(26)
|
Outcome Measures
| Title | Tinnitus Functional Index (TFI); Measure of Tinnitus Distress |
|---|---|
| Description | 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. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | R-ICBT | F-ICBT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 63 | 63 |
| T0: Baseline |
48.7
(25.51)
|
50.52
(26.65)
|
| T1: Post-intervention 1 |
32.13
(21.38)
|
28.95
(20.75)
|
| T2: Post-intervention 2 (both completed full ICBT) |
30.66
(23.45)
|
28.95
(20.75)
|
| T3: 2-month post-intervention |
23.81
(9.87)
|
27.16
(20.78)
|
| Title | Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition |
|---|---|
| Description | 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. |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | R-ICBT | F-ICBT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 63 | 63 |
| T0: Baseline |
44.67
(20.43)
|
42.52
(18.58)
|
| T1: Post-intervention 1 |
30.96
(20.03)
|
27.26
(20.17)
|
| T2: Post-intervention 2 (both completed full ICBT) |
28.93
(17.81)
|
27.26
(20.17)
|
| T3: 2-month post-intervention |
25.30
(15.84)
|
23.07
(17.54)
|
| Title | Patient Health Questionnaire (PHQ-9); Measure of Depression |
|---|---|
| Description | 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). |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | R-ICBT | F-ICBT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 63 | 63 |
| T0: Baseline |
9.17
(7.12)
|
9.10
(7.14)
|
| T1: Post-intervention 1 |
4.96
(5.07)
|
4.32
(3.95)
|
| T2: Post-intervention 2 (both completed full ICBT) |
5.04
(5.7)
|
4.32
(3.95)
|
| T3: 2-month post-intervention |
3.35
(4.17)
|
4.12
(4.4)
|
| Title | Generalized Anxiety Disorder (GAD-7); Measure of Anxiety |
|---|---|
| Description | 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). |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | R-ICBT | F-ICBT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 63 | 63 |
| T0: Baseline |
7.75
(6.77)
|
9.19
(6.39)
|
| T1: Post-intervention 1 |
5.21
(5.62)
|
4.48
(4.17)
|
| T2: Post-intervention 2 (both completed full ICBT) |
4.86
(5.84)
|
4.48
(4.17)
|
| T3: 2-month post-intervention |
3.70
(3.88)
|
4.68
(4.75)
|
| Title | Insomnia Severity Index (ISI); Measure of Insomnia |
|---|---|
| Description | 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). |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | R-ICBT | F-ICBT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 63 | 63 |
| T0: Baseline |
11.90
(7.45)
|
12.25
(7.7)
|
| T1: Post-intervention 1 |
8.93
(6.5)
|
7.46
(5.8)
|
| T2: Post-intervention 2 (both completed full ICBT) |
8.43
(5.93)
|
7.46
(5.8)
|
| T3: 2-month post-intervention |
7.13
(5)
|
6.33
(6.08)
|
| Title | EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life |
|---|---|
| Description | 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). |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | R-ICBT | F-ICBT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 63 | 63 |
| T0: Baseline |
72.59
(17)
|
75.43
(15.92)
|
| T1: Post-intervention 1 |
79.71
(12.14)
|
78.15
(17.51)
|
| T2: Post-intervention 2 (both completed full ICBT) |
76.43
(15.79)
|
78.15
(17.51)
|
| T3: 2-month post-intervention |
78.22
(11.29)
|
85.87
(6.91)
|
| Title | Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem |
|---|---|
| Description | 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). |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | R-ICBT | F-ICBT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 63 | 63 |
| T0: Baseline |
5.79
(4.55)
|
6.29
(5.70)
|
| T1: Post-intervention 1 |
3.21
(3.32)
|
2.85
(2.66)
|
| T2: Post-intervention 2 (both completed full ICBT) |
3.36
(3.68)
|
2.85
(2.66)
|
| T3: 2-month post-intervention |
2.78
(3.19)
|
2.07
(2.12)
|
| Title | Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem |
|---|---|
| Description | 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). |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | R-ICBT | F-ICBT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 63 | 63 |
| T0: Baseline |
6.19
(4.84)
|
5.94
(5.06)
|
| T1: Post-intervention 1 |
3.75
(3.7)
|
4.59
(4.01)
|
| T2: Post-intervention 2 (both completed full ICBT) |
4.71
(4.32)
|
4.59
(4.01)
|
| T3: 2-month post-intervention |
4.65
(3.59)
|
3.13
(2.36)
|
| Title | Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance |
|---|---|
| Description | 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). |
| Time Frame | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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 |
| Arm/Group Title | R-ICBT | F-ICBT |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 63 | 63 |
| T0: Baseline |
1.17
(1.4)
|
1.22
(1.3)
|
| T1: Post-intervention 1 |
1.0
(1.39)
|
0.67
(1.07)
|
| T2: Post-intervention 2 (both completed full ICBT) |
.96
(1.3)
|
.67
(1.07)
|
| T3: 2-month post-intervention |
0.91
(1.08)
|
0.47
(0.74)
|
Adverse Events
| Time Frame | 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 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Our definition of adverse events is the same as clinical trials.gov. | |||
| Arm/Group Title | R-ICBT | F-ICBT | ||
| Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
| R-ICBT | F-ICBT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/63 (0%) | 0/63 (0%) | ||
Serious Adverse Events |
||||
| R-ICBT | F-ICBT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/63 (0%) | 0/63 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| R-ICBT | F-ICBT | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/63 (0%) | 0/63 (0%) | ||
Limitations/Caveats
The study was done during the height of the COVID-19 pandemic, during a time where day-to-day living was disrupted for most people. This may have been one of the key reasons for poor engagement with the intervention and poor compliance with the completion of outcome measures.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Vinaya Manchaiah, Jo Mayo Endowed Professor |
|---|---|
| Organization | Lamar University |
| Phone | (409) 812 9443 |
| vmanchaiah@lamar.edu |
Responsible Party:
Vinaya Manchaiah,
Jo Mayo Endowed Professor,
Lamar University
ClinicalTrials.gov Identifier:
NCT04335812
Other Study ID Numbers:
- IRB-FY20-200-1
First Posted:
Apr 6, 2020
Last Update Posted:
Jul 16, 2021
Last Verified:
Jul 1, 2021