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NCT01229709 · ClinicalTrials.gov registry record · Phase 2
Mindfulness Based Tinnitus Reduction (MBTR): A Symptom Perception Shift Program
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT01229709: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT01229709 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01229709, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
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 progra
Primary Outcome
The THI is a self-report measure that can be used in a busy clinical practice to quantify the impact of tinnitus on daily living. The measure is brief, easy to administer and interpret, broad in scope, and psychometrically robust. Convergent validity was assessed using another measure of perceived tinnitus handicap (Tinnitus Handicap Questionnaire). Construct validity was assessed using the Beck Depression Inventory, Modified Somatic Perception Questionnaire, symptom rating scales (annoyance, sl
Interventions
- BEHAVIORAL Mindfulness Based Tinnitus Reduction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-01 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
What the finished NCT01229709 record still lists
NCT01229709 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Mindfulness Based Tinnitus Reduction is the first listed.
NCT01229709 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01229709 about?
NCT01229709 is a clinical study titled "Mindfulness Based Tinnitus Reduction (MBTR): A Symptom Perception Shift Program". 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 pe...
What is the current status of trial NCT01229709?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2011-01. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01229709?
The interventions under investigation include: Mindfulness Based Tinnitus Reduction (BEHAVIORAL).
Who is sponsoring clinical trial NCT01229709?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01229709's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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