Internet-based Cognitive Behavioural Therapy for Spanish Tinnitus Sufferers

NCT04335929 | Completed Results

• 1 other identifier: IRB-FY20-200-2
• Study Type: interventional
• Target: 46
• 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 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 which is also available in Spanish. However, the outcomes of the Spanish version of the program has not been evaluated. The purpose of the current study is to determine the feasibility of guided Spanish version of the Internet-based CBT (ICBT) using audiological support on tinnitus distress and tinnitus-related comorbidities.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

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

  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.

  T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)

Secondary Outcomes (8)

• Tinnitus Cognition Questionnaire (TCQ); Measure of Tinnitus Cognition

  T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)

• Patient Health Questionnaire (PHQ-9); Measure of Depression

  T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)

• Generalized Anxiety Disorder (GAD-7); Measure of Anxiety

  T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)

• Insomnia Severity Index (ISI); Measure of Insomnia

  T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)

• EuroQol EQ-5D-5L VAS; Measure of Health-related Quality of Life

  T0: Baseline, T1: Post-intervention (8-weeks from baseline), T2: 2-months post-intervention (16-weeks from baseline)

Study Arms (1)

Internet-based Cognitive Behavior Therapy

EXPERIMENTAL

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.

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.

Internet-based Cognitive Behavior Therapy

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 adults from across the globe;
• the ability to read and type in 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;
• 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;

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 Links

• Study website

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

vmanchaiah@lamar.edu

(409) 812 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jo Mayo Endowed Professor

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 7, 2020
• Study Start: May 4, 2020
• Primary Completion: August 14, 2020
• Study Completion: August 14, 2020
• Last Updated: August 6, 2021
• Results First Posted: July 19, 2021

Record last verified: 2021-07

Data Sharing

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

Locations

US (1)