- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04335812
Internet-based Cognitive Behavioral Therapy for Tinnitus Sufferers (ICBT)
Internet-based Cognitive Behavioral Therapy for Tinnitus Sufferers: Comparing the Full CBT Program With Relaxation Only Program
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Beaumont, Texas, United States, 77705
- Lamar University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
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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:
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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
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tinnitus Functional Index (TFI); Measure of Tinnitus Distress
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
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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.
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition
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
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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.
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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
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Patient Health Questionnaire (PHQ-9); Measure of Depression
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
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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).
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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
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Generalized Anxiety Disorder (GAD-7); Measure of Anxiety
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
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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).
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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
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Insomnia Severity Index (ISI); Measure of Insomnia
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
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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).
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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
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EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life
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
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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).
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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
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Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem
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
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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).
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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
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Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem
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
|
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).
|
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
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Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance
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
|
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).
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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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vinaya Manchaiah, PhD, Lamar University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-FY20-200-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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