Clinical trial NCT04004260: CBT-based Internet Intervention for Adults With Tinnitus in the United States
Official title: Cognitive Behavior Therapy Based Self-help Delivered Via the Internet for Tinnitus Sufferers: Efficacy Trial in the U.S. Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Lead sponsor: Lamar University
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experimental group will initially undergo the ICBT intervention while the control group are monitored weekly. Once the experimental group has completed the intervention, the control group will undertake the ICBT intervention.
Primary purpose: TREATMENT

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.

Intervention: The intervention offered 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.

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.

Eligibility criteria: Inclusion Criteria:

1. aged 18 years and older living in the State of Texas, USA;
2. the ability to read and type in English or Spanish;
3. no barriers to using a computer (e.g. no significant fine motor control or visual problems);
4. Internet and e-mail access and the ability to use it;
5. commitment to completing the program;
6. completion of the online screening and outcome questionnaires;
7. agreeing to participate in either group and be randomized to one of these groups;
8. 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;
9. be available for 12 months after starting the study to complete a 1-year follow-up questionnaire;
10. suffering with experiencing tinnitus for a minimum period of 3 months; and
11. tinnitus outcome measure scores indicating the need for tinnitus care \[25 or above on the Tinnitus Functional Index (TFI)\].

Exclusion Criteria:

1. reporting any major medical or psychiatric conditions;
2. reporting pulsatile, objective or unilateral tinnitus, which has not been investigated medically;
3. tinnitus as a consequence of a medical disorder, still under investigation; and
4. undergoing any other tinnitus therapy while participating in this study.

Primary outcomes:
measure: Tinnitus Functional Index (TFI) - Measure of Tinnitus Distress
timeFrame: 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
Secondary outcomes:
measure: Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition
timeFrame: Baseline, Post-intervention (8-weeks from baseline), 2-months post-intervention (16 weeks from baseline)
measure: Patient Health Questionnaire (PHQ-9); Measure of Depression
timeFrame: Baseline, Post-intervention (8-weeks from baseline), 2-months post-intervention (16 weeks from baseline)
measure: Generalized Anxiety Disorder (GAD-7); Measure of Anxiety
timeFrame: Baseline, Post-intervention (8-weeks from baseline), 2-months post-intervention (16 weeks from baseline)
measure: Insomnia Severity Index (ISI); Measure of Insomnia
timeFrame: Baseline, Post-intervention (8-weeks from baseline), 2-months post-intervention (16 weeks from baseline)
measure: EuroQol EQ-5D-5L VAS Scores; Measure of Health-related Quality of Life
timeFrame: 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
measure: Tinnitus and Hearing Survey (THS) - Tinnitus Sub-scale; Measure of Tinnitus Problem
timeFrame: 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
measure: Tinnitus and Hearing Survey (THS) - Hearing Sub-scale; Measure of Hearing Problem
timeFrame: 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
measure: Tinnitus and Hearing Survey (THS) - Sound Tolerance Sub-scale; Measure of Sound Tolerance
timeFrame: 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
Other outcomes:
Locations:
city: Beaumont
country: United States
facility: Lamar University
state: Texas
Study officials:
affiliation: Lamar University
name: Vinaya Manchaiah, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: W Beukes E, Andersson G, Fagelson M, Manchaiah V. Internet-Based Audiologist-Guided Cognitive Behavioral Therapy for Tinnitus: Randomized Controlled Trial. J Med Internet Res. 2022 Feb 14;24(2):e27584. doi: 10.2196/27584.
citation: Beukes EW, Andersson G, Manchaiah V. Patient Uptake, Experiences, and Process Evaluation of a Randomized Controlled Trial of Internet-Based Cognitive Behavioral Therapy for Tinnitus in the United States. Front Med (Lausanne). 2021 Nov 17;8:771646. doi: 10.3389/fmed.2021.771646. eCollection 2021.