Internet-based Cognitive Behavioral Therapy for Tinnitus Sufferers: Comparing the Full CBT Program With Relaxation Only Program
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Lamar University
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Tinnitus Functional Index (TFI); Measure of Tinnitus Distress
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
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.
Intervention: Internet-based Cognitive Behavior Therapy (Behavioral)
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
Intervention: Internet-based Cognitive Behavior Therapy (Behavioral)
Outcomes
Primary Outcomes
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
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 Outcomes
- 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)
- 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)
- 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) - 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)
- 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)
- 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 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)
- 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)
Investigators
Vinaya Manchaiah
Jo Mayo Endowed Professor
Lamar University