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Mindfulness Based Tinnitus Reduction (MBTR): A Symptom Perception Shift Program

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01229709
First received: October 26, 2010
Last updated: October 26, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Tinnitus
Anxiety
Depression
Behavioral: Mindfulness Based Tinnitus Reduction
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Mindfulness Based Tinnitus Reduction (MBTR) Study: A Symptom Perception Shift Program

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in Tinnitus Handicap Inventory (THI) [ Time Frame: Baseline, Post-intervention (within 2 weeks after completion of 8-week intervention) ] [ Designated as safety issue: No ]
    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, sleep disruption, depression, and concentration), and perceived tinnitus pitch and loudness judgments. Pre-assessment measures were individually administered to participants at the UCSF Audiology Clinic immediately after consents were signed, no earlier than 2 weeks prior to the start of the intervention. Post-assessment measures were filled out at home and mailed back to the Clinic by participants no more than 2 weeks after the intervention's completion.


Secondary Outcome Measures:
  • Change in Symptom Checklist-90- Revised [ Time Frame: Baseline, Post-intervention (within 2 weeks after completion of 8-week intervention) ] [ Designated as safety issue: No ]
    Pre-assessment measures were individually administered to participants at the UCSF Audiology Clinic immediately after consents were signed, no earlier than 2 weeks prior to the start of the intervention. Post-assessment measures were filled out at home and mailed back to the Clinic by participants no more than 2 weeks after the intervention's completion.

  • Change in Five-Factor Mindfulness Questionnaire (FFMQ) [ Time Frame: Baseline, Post-intervention (within 2 weeks after completion of 8-week intervention) ] [ Designated as safety issue: No ]
    Pre-assessment measures were individually administered to participants at the UCSF Audiology Clinic immediately after consents were signed, no earlier than 2 weeks prior to the start of the intervention. Post-assessment measures were filled out at home and mailed back to the Clinic by participants no more than 2 weeks after the intervention's completion.

  • Change in Hamilton Anxiety & Depression Scale (HADS) [ Time Frame: Baseline, Post-intervention (within 2 weeks after completion of 8-week intervention) ] [ Designated as safety issue: No ]
    Pre-assessment measures were individually administered to participants at the UCSF Audiology Clinic immediately after consents were signed, no earlier than 2 weeks prior to the start of the intervention. Post-assessment measures were filled out at home and mailed back to the Clinic by participants no more than 2 weeks after the intervention's completion.

  • Change in Tinnitus Visual Analogue Scale (VAS) [ Time Frame: Baseline, Post-intervention (within 2 weeks after completion of 8 week intervention) ] [ Designated as safety issue: No ]
    Tinnitus Visual Analogue Scale (VAS) is a collection of straight lines 100mm in length anchored at the end with extremes (e.g., no tinnitus distress, extreme tinnitus distress) of the tinnitus sensation, feeling or response. This means of measuring distress has been suggested for use in research (Axelsson, Coles, Erlandsson, Meikle, & Vernon, 1993). Pre-assessment measures were individually administered to participants at the UCSF Audiology Clinic immediately after consents were signed, no earlier than 2 weeks prior to the start of the intervention. Post-assessment measures were filled out at home and mailed back to the Clinic by participants no more than 2 weeks after the intervention's completion.


Enrollment: 10
Study Start Date: January 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness Based Tinnitus Reduction Behavioral: Mindfulness Based Tinnitus Reduction
The Mindfulness Based Tinnitus Reduction (MBTR) program will be held for two-and-a-half hours one evening per week over 8 consecutive weeks. Participants will also complete a day-long Sunday retreat between the 6th and 7th sessions. Each participant will take part in a 30-minute private interview with the course instructor prior to beginning the program.
Other Name: MBTR
No Intervention: Tinnitus Counseling Only Control
Control group subjects will have had treatment as usual (TAU) care from the UCSF Audiology Clinic which includes Tinnitus Counseling (TC) at least three-months prior to enty into the study.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18
  • English speaking
  • Duration of subjective chronic tinnitus > 6 months
  • Moderate to strong tinnitus annoyance (Minimum THI score of > 28 )

Exclusion Criteria:

  • Age < 18
  • Non-English speaking
  • > Moderate Hearing Loss
  • Duration of chronic subjective tinnitus < 6 months
  • Treatable tinnitus
  • Severe depression and/or anxiety
  • Recent (within 3-month) history of alcohol or drug abuse or dependence other than tobacco or caffeine
  • No recent (within 3 months) start of new tinnitus treatment
  • THI score < 28
  • No previous psychological treatment for their tinnitus.
  • History of traumatic brain injury (TBI) with loss of consciousness (LOC)
  • History of psychotic disorders or dementia
  • Currently undergoing litigation or legal matters related to auditory disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01229709

Locations
United States, California
UCSF
San Francisco, California, United States, 94115
UCSF Audiology Clinic
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Study Director: Jennifer Gans, PsyD Clinical Psychologist
  More Information

Publications:
Kabat-Zinn, J., Wheeler, E., Light, T., Skillings, A., Scharf, M. J., Cropey, T. G., et al. (2003) Part II: Influence of a mindfulness meditation-based stress reduction intervention on rates of skin clearing in patients with moderate to severe psoriasis undergoing phototherapy (UVB) and photochemo-therapy (PUVA). Constructivism in the Human Sciences; 8(2): 85-106.
Surawy C, Roberts J, Silver A. (2005). The effect of mindfulness training on mood and measures of fatigue, activity, and quality of life in patients with chronic fatigue syndrome on a hospital waiting list: a series of exploratory studies. Behavioural and Cognitive Psychotherapy; 33:103-09

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01229709     History of Changes
Other Study ID Numbers: H8935-35834-01
Study First Received: October 26, 2010
Last Updated: October 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Tinnitus
Mindfulness
MBSR
Mindfulness Based Stress Reduction
MBTR

Additional relevant MeSH terms:
Depression
Tinnitus
Behavioral Symptoms
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on November 23, 2014