Treatment of Tinnitus Using a Web-based Sound and Cognitive Behavioral Therapy

NCT02438891 | Completed

• 1 other identifier: 2014-1358
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Most tinnitus sufferers experiences significant anxiety or depression that worsens the subjective symptoms related to tinnitus. In this study, we intend to use internet-based cognitive behavioral therapy (CBT) in addition to sound therapy to provide psychotherapy to patients with tinnitus. Multiple research studies have found CBT to be effective in improving the subjective symptoms of tinnitus. The internet-based CBT course developed for this study is 8 weeks in duration and organized into eight 1-week modules; each module contains 2-4 separate lessons and homework assignments. Patients will be given unique usernames and passwords. In each weekly module, patients will review educational materials online, do exercises. and will be given feedback based on the results of the completed exercises. In addition, patients are given different meditation exercises each week for relaxation and coping with their tinnitus. These interactive materials enable patients to manage and control any negative feelings and thoughts that may be associated with tinnitus and help take their attention away from tinnitus. Tinnitus loudness and annoyance will be measured before and after the program. An internet-based course enables care providers to monitor patients' progress with the CBT course remotely, and allows patients to learn CBT at their own convenience and schedule.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• Subjective improvement of tinnitus

  Subjective improvement, from baseline, of tinnitus-related stress, emotions, feelings and thoughts. Evaluated by pre- and post-course audiometry and surveys, and patient feedback.

  9 weeks

Secondary Outcomes (4)

• Beck's depression survey

  9 weeks

• Post-traumatic Stress Disorder civilian survey

  9 weeks

• Tinnitus handicap inventory survey

  9 weeks

• GAD-7 survey

  9 weeks

Study Arms (1)

CBT course

EXPERIMENTAL

8-week internet-based cognitive behavioral therapy and sound therapy course

Behavioral: Cognitive behavioral therapy

Interventions

Cognitive behavioral therapy BEHAVIORAL

Cognitive behavioral therapy is a form of tinnitus psychotherapy which aims to help patients control negative thoughts or emotions associated with tinnitus.

CBT course

Eligibility Criteria

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

You may qualify if:

• Subjects with the chief complaint of tinnitus for 6 months or more
• years or older
• Male or Female
• Internet and e-mail access at home
• Adequate command of English to fill out the surveys and questionnaires in the website

You may not qualify if:

• Aged less than 18 years
• History of Psychosis
• Subjects currently taking medications known to cause tinnitus (aspirin, ibuprofen, naproxen) which cannot be stopped.
• Active illicit drug use, alcohol dependence
• Patients with severe depression based on the Beck's depression inventory survey scores
• Patients with severe anxiety based on the GAD-7 survey scores
• Patients with severe Post Traumatic Stress Disorder (PTSD) based on the PTSD- civilian version survey
• Not currently undergoing CBT with a Psychologist
• No other concurrent tinnitus therapy
• Pregnant or breastfeeding.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (9)

• Cima RF, Maes IH, Joore MA, Scheyen DJ, El Refaie A, Baguley DM, Anteunis LJ, van Breukelen GJ, Vlaeyen JW. Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial. Lancet. 2012 May 26;379(9830):1951-9. doi: 10.1016/S0140-6736(12)60469-3.

  PMID: 22633033 BACKGROUND

• Zachriat C, Kroner-Herwig B. Treating chronic tinnitus: comparison of cognitive-behavioural and habituation-based treatments. Cogn Behav Ther. 2004;33(4):187-98. doi: 10.1080/16506070410029568.

  PMID: 15625793 BACKGROUND

• Andersson G, Kaldo V. Internet-based cognitive behavioral therapy for tinnitus. J Clin Psychol. 2004 Feb;60(2):171-8. doi: 10.1002/jclp.10243.

  PMID: 14724924 BACKGROUND

• Sweetow RW. Cognitive aspects of tinnitus patient management. Ear Hear. 1986 Dec;7(6):390-6. doi: 10.1097/00003446-198612000-00008.

  PMID: 3792682 BACKGROUND

• Jasper K, Weise C, Conrad I, Andersson G, Hiller W, Kleinstauber M. Internet-based guided self-help versus group cognitive behavioral therapy for chronic tinnitus: a randomized controlled trial. Psychother Psychosom. 2014;83(4):234-46. doi: 10.1159/000360705. Epub 2014 Jun 19.

  PMID: 24970708 RESULT

• Kaldo V, Haak T, Buhrman M, Alfonsson S, Larsen HC, Andersson G. Internet-based cognitive behaviour therapy for tinnitus patients delivered in a regular clinical setting: outcome and analysis of treatment dropout. Cogn Behav Ther. 2013;42(2):146-58. doi: 10.1080/16506073.2013.769622. Epub 2013 Feb 25.

  PMID: 23432207 RESULT

• Hesser H, Gustafsson T, Lunden C, Henrikson O, Fattahi K, Johnsson E, Zetterqvist Westin V, Carlbring P, Maki-Torkko E, Kaldo V, Andersson G. A randomized controlled trial of Internet-delivered cognitive behavior therapy and acceptance and commitment therapy in the treatment of tinnitus. J Consult Clin Psychol. 2012 Aug;80(4):649-61. doi: 10.1037/a0027021. Epub 2012 Jan 16.

  PMID: 22250855 RESULT

• Kaldo V, Levin S, Widarsson J, Buhrman M, Larsen HC, Andersson G. Internet versus group cognitive-behavioral treatment of distress associated with tinnitus: a randomized controlled trial. Behav Ther. 2008 Dec;39(4):348-59. doi: 10.1016/j.beth.2007.10.003. Epub 2008 Apr 20.

  PMID: 19027431 RESULT

• Kaldo-Sandstrom V, Larsen HC, Andersson G. Internet-based cognitive-behavioral self-help treatment of tinnitus: clinical effectiveness and predictors of outcome. Am J Audiol. 2004 Dec;13(2):185-92. doi: 10.1044/1059-0889(2004/023).

  PMID: 15903144 RESULT

MeSH Terms

Conditions

Tinnitus

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hamid Djalilian, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

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: Director, Division of Neurotology and Skull Base Surgery

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 8, 2015
• Study Start: July 14, 2019
• Primary Completion: December 16, 2020
• Study Completion: December 16, 2020
• Last Updated: April 5, 2022

Record last verified: 2022-03

Locations

US (1)