Cognitive Behavior Therapy Based Self-help Delivered Via the Internet for Tinnitus Sufferers: Efficacy Trial in the U.S. Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Lamar University
- Enrollment
- 315
- 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 in the U.S. (less than 1%), partly attributed to a lack of trained professionals who can deliver CBT. To improve access to CBT for tinnitus, and online CBT program has been developed. The purpose of this study is to determine the feasibility and efficacy of a CBT Internet-based intervention for adults with tinnitus in the United States.
Detailed Description
Objective: This study aims to determine the feasibility and efficacy of an Internet-based Cognitive Behavior Therapy (ICBT) in reducing the impact associated with tinnitus in the United States.
Hypothesis: It is hypothesized that ICBT will result in reduced tinnitus-related distress, decreased sleep disturbance, decreased anxiety and depression, and improved health-related quality of life in a treatment group as compared with adults in the weekly check-in control-group in the U.S. population. 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 ICBT on tinnitus distress.
Setting: This will be an Internet-based study for adults with tinnitus living in the State of Texas, 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. 80 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 language and tinnitus 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 State of Texas, USA;
- •the ability to read and type in English or Spanish;
- •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;
- •agreeing to participate in either group and be randomized to one of these groups;
- •understanding and working 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;
- •suffering with experiencing tinnitus for a minimum period of 3 months; and
- •tinnitus outcome measure scores indicating the need for tinnitus care [25 or above on the Tinnitus Functional Index (TFI)].
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
Experimental group
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.
Intervention: Internet-based Cognitive Behavior Therapy (Behavioral)
Weekly check-in control group
The weekly check-in control group will be monitored weekly by means of the Tinnitus Handicap Inventory-Screening version (THI-S) and the Tinnitus Qualities Questionnaire (TQQ). Once the experimental group completes the ICBT intervention, the control group undertake the same ICBT intervention.
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 after the experimental group completed the intervention, T2: Post-intervention after control group completed intervention; T3: 2-months post-intervention
The Tinnitus Functional Index (TFI) is a 25-item questionnaire that evaluates tinnitus distress. The total possible score ranges from 0-to-100 with higher scores indicate more severe tinnitus distress (i.e., worse outcome). Scores \>25 indicate tinnitus is a significant problem requiring tinnitus intervention.
Secondary Outcomes
- Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem(T0: Baseline, T1: Post-intervention after the experimental group completed the intervention, T2: Post-intervention after control group completed intervention; T3: 2-months post-intervention)
- EuroQol EQ-5D-5L VAS Scores; Measure of Health-related Quality of Life(T0: Baseline, T1: Post-intervention after the experimental group completed the intervention, T2: Post-intervention after control group completed intervention; T3: 2-months post-intervention)
- Insomnia Severity Index (ISI); Measure of Insomnia(Baseline, Post-intervention (8-weeks from baseline), 2-months post-intervention (16 weeks from baseline))
- Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem(T0: Baseline, T1: Post-intervention after the experimental group completed the intervention, T2: Post-intervention after control group completed intervention; T3: 2-months post-intervention)
- Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition(Baseline, Post-intervention (8-weeks from baseline), 2-months post-intervention (16 weeks from baseline))
- Patient Health Questionnaire (PHQ-9); Measure of Depression(Baseline, Post-intervention (8-weeks from baseline), 2-months post-intervention (16 weeks from baseline))
- Generalized Anxiety Disorder (GAD-7); Measure of Anxiety(Baseline, Post-intervention (8-weeks from baseline), 2-months post-intervention (16 weeks from baseline))
- Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance(T0: Baseline, T1: Post-intervention after the experimental group completed the intervention, T2: Post-intervention after control group completed intervention; T3: 2-months post-intervention)
Investigators
Vinaya Manchaiah
Jo Mayo Endowed Professor
Lamar University