Internet-based Cognitive Behavioral Therapy for Tinnitus
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|ClinicalTrials.gov Identifier: NCT02438891|
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : April 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Behavioral: Cognitive behavioral therapy||Not Applicable|
The purpose of this study is to evaluate a internet-based cognitive behavioral therapy (CBT) system as a method of treating patients with tinnitus. Tinnitus is a common symptom that is defined as the perception of the sound in the ears without any external source. It is often described by the patients as ringing or a buzzing sound, alone or more often as a mixture of sounds. This symptom afflicts 10 to 15% of the adult population. It usually does not bother patients significantly; however about 10% of the patients will suffer severe problems which include insomnia, anxiety, depression and other emotional problems. The various forms of treatment for tinnitus that have been tested in properly controlled trials can be classified as pharmacological, sound therapy and psychological. In clinical trials, no pharmacological agent has been shown to have lasting effect on the presence or severity of tinnitus. Despite numerous available treatments for tinnitus, it is rarely curable and the sufferer must use coping strategies to decrease the distress.
CBT is a psychological treatment that has emerged as consistently beneficial in terms of affecting overall well-being and reducing the level of tinnitus-related annoyance. CBT is a form of psychotherapy for tinnitus that intends to measure and improve the affected individual's reaction to tinnitus. It does not eliminate the auditory perception, but reduces or corrects negative responses to tinnitus. CBT identifies negative automatic thought and determines its validity with the patient. It intends to modify negative automatic thoughts to more positive and realistic ones. Using this method, the patients with tinnitus can function better despite the presence of tinnitus.
One of the problems with CBT is the shortage of clinicians who are specialized in CBT for tinnitus. For this reason, some programs have been developed which utilize guided or therapist-supported self-help approach. Internet based CBT have been developed for patients with tinnitus in several studies. Anderson and colleagues in Sweden compared pre and post therapeutic effect of CBT in 117 participants with tinnitus duration of more than 6 months. All subjects had been offered the CBT program and 96 provided outcome measures. Tinnitus-related distress, depression, and diary ratings of annoyance decreased significantly. Also in comparison to a control group, they found out that these patients showed an improvement of at least 50% on the Tinnitus Reaction Questionnaire. They concluded that CBT via the Internet can help individuals decrease annoyance associated with tinnitus. In another study by Kaldo et.al., they evaluated the difference between internet-based CBT and group-based CBT. The subjects in internet treatment consumed less therapist time and it was 1.7 times as cost-effective as the group treatment. However some studies support the utilization of self-help methods for treatment of tinnitus, but there are still some problems with using these methods such as accessibility to internet, knowledge of the patients on using computers and internet, interactivity and user friendly structure of the software that is used for the program and time management of the patients for practicing methods and exercises embedded in this program. By correcting and rectifying these 3 of 25 issues, internet-based self-help programs will better serve the patients with their cost-effective and time saving benefits. Currently there is no web-based CBT for the treatment of tinnitus available.
The objective of this study is to evaluate an internet-based CBT course for the treatment of tinnitus. Adult patients (18+ years) with moderate-to-severe tinnitus (see additional Inclusion Criteria) will be selected for enrollment and will take pre-course surveys and undergo tinnitus-specific audiometry testing. The 8-week course will be completed by the patients online, at home. Following completion of the course, enrollees will repeat the surveys and tinnitus-specific audiometry tests.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of an Internet-based Sound and Cognitive Behavioral Therapy Course for Treatment for Tinnitus|
|Actual Study Start Date :||February 16, 2018|
|Estimated Primary Completion Date :||February 2024|
|Estimated Study Completion Date :||February 2024|
Experimental: CBT course
8-week internet-based cognitive behavioral therapy and sound therapy course
Behavioral: Cognitive behavioral therapy
Cognitive behavioral therapy is a form of tinnitus psychotherapy which aims to help patients control negative thoughts or emotions associated with tinnitus.
- Subjective improvement of tinnitus [ Time Frame: 9 weeks ]Subjective improvement, from baseline, of tinnitus-related stress, emotions, feelings and thoughts. Evaluated by pre- and post-course audiometry and surveys, and patient feedback.
- Beck's depression survey [ Time Frame: 9 weeks ]pre-course and post-course survey for subjective assessment of tinnitus
- Post-traumatic Stress Disorder civilian survey [ Time Frame: 9 weeks ]pre-course and post-course survey for subjective assessment of tinnitus
- Tinnitus handicap inventory survey [ Time Frame: 9 weeks ]pre-course and post-course survey for subjective assessment of tinnitus
- GAD-7 survey [ Time Frame: 9 weeks ]pre-course and post-course survey for subjective assessment of tinnitus
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438891
|Contact: Hamid Djalilian, MD||(800) email@example.com|
|Contact: Yaser Ghavami, MD||(800) firstname.lastname@example.org|
|United States, California|
|University of California Irvine Medical Center||Recruiting|
|Orange, California, United States, 92868|
|Contact: Hamid Djalilian, MD 714-456-5753 email@example.com|
|Principal Investigator:||Hamid Djalilian, MD||University of California, Irvine|