CBT-based Internet Intervention for Adults With Tinnitus in the United States

NCT04004260 | Completed Results DMC

• 1 other identifier: R21DC017214
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• Tinnitus Functional Index (TFI) - Measure of Tinnitus Distress

  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.

  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 (8)

• 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)

• Insomnia Severity Index (ISI); Measure of Insomnia

  Baseline, Post-intervention (8-weeks from baseline), 2-months post-intervention (16 weeks from baseline)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Behavioral: Internet-based Cognitive Behavior Therapy

Weekly check-in control group

OTHER

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.

Behavioral: Internet-based Cognitive Behavior Therapy

Interventions

Internet-based Cognitive Behavior Therapy BEHAVIORAL

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.

Also known as: ICBT

Experimental group; Weekly check-in control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[25 or above on the Tinnitus Functional Index (TFI)\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lamar University: lead

Study Sites (1)

Lamar University

Beaumont, Texas, 77705, United States

Location

Related Publications (2)

• 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.

  PMID: 35156936 DERIVED

• 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.

  PMID: 34869490 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and 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.

Results Point of Contact

• Title: Vinaya Manchaiah, Jo Mayo Endowed Professor
• Organization: Lamar University

vmanchaiah@lamar.edu

(409) 821 9443

Study Officials

• Vinaya Manchaiah, PhD

  Lamar University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jo Mayo Endowed Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 2, 2019
• Study Start: March 1, 2020
• Primary Completion: July 3, 2020
• Study Completion: July 3, 2020
• Last Updated: August 11, 2021
• Results First Posted: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Available now
• Access Criteria: Data are openly available

Locations

US (1)