This study is a randomized, controlled trial of Mindfulness Based Tinnitus Reduction (MBTR) vs. Treatment As Usual (TAU). This study aims to determine patient's benefit from participating in an 8-week MBTR program as measured by a reduction in clinical symptoms, if present, and a tinnitus symptom perception shift. Sixty-four tinnitus patients who have previously received Tinnitus Counseling (TAU) at the UCSF Audiology Clinic under the direction of Robert Sweetow, PhD will be invited to participate in the MBTR study. Subjects will be randomly assigned to the experimental and control groups of 32 each. All subjects will have received Tinnitus Counseling at least 6-months prior to entry into the study. Tinnitus symptom activity and discomfort as well as psychological outcomes will be assessed by self-report questionnaires. The primary outcome measure is the Tinnitus Handicap Inventory (THI) measuring tinnitus symptom severity. The secondary outcome measures include the Tinnitus Visual Analogue Scale (TVAS), the Symptom Checklist-90-Revised (SCL-90-R), Hamilton Anxiety and Depression Scale (HADS), and the Five Factor Mindfulness Questionnaire (FFMQ). In addition to tinnitus symptom severity, secondary outcome measures are used to measure change in mindfulness and other clinical symptoms such as anxiety and depression, if they exist. The experimental group will complete measures at pre-, post-, at 3-months and 12-months follow-up. A 12-month follow-up assessment will be conducted with the experimental group to identify any enduring effects of the treatment. The control group will fill out measures at pre-, post-, and 3-month time periods. The 12-month follow-up will be conducted with the experimental group only and will be the uncontrolled portion of the study.
The purpose of this study is to 1) Design and execute an MBTR program for patients with tinnitus within the UCSF Department of Audiology. 2) Determine patient's benefit from participating in an 8-week MBTR program as measured by a decrease in tinnitus distress, and a reduction in clinical symptoms (i.e., depression, anxiety), if present. 3) Compare the responses on study measures to those of the control group. 4) Collect follow-up data at 6- and 12-months post intervention to assess enduring effects, if any, in the experimental group. 5) Use the data and patient feedback to modify UCSF's Audiology program and guide future programming in regards to the treatment and care of patients with tinnitus.
Estimated Enrollment: 64
Study Start Date: January 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)