Cognitive Behavioral Therapy (CBT) for Tinnitus

Tinnitus Clinical Trial

Official title:

Cognitive-behavioral Therapy for Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724152
• Other study ID #: C6324-P
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 23, 2008
• Last updated: April 16, 2015
• Start date: February 2009
• Est. completion date: February 2011

Study information

• Verified date: April 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study examined how useful it is to teach veterans coping skills for dealing with tinnitus, also called ringing in the ears. A psychological intervention, cognitive-behavioral therapy, was used to teach coping skills even though tinnitus is not a psychological disorder. Participants in Period 1 of the study were assigned to one of two groups for the duration of the study and were blinded to their group assignment until the end of the study. One group received education about tinnitus. The other group received education about tinnitus plus additional ways to cope with problems associated with tinnitus such as sleep disturbance and frustration. Participants were selected to participate if their tinnitus was severe and they had been exposed to loud sound. Participants attended up to six weekly group meetings. It was predicted that participants who were randomly assigned to the cognitive behavioral therapy group would report a greater reduction in tinnitus severity than education controls. During Period 2 of the study, a third "standard care" arm was added. Baseline and outcome data of the 4 participants who completed the study after this third arm was added to the study design are not reported.

Description:

The objectives of this study were to (1) develop a novel, integrative, psychological intervention, specifically cognitive-behavioral therapy (CBT), for the treatment of tinnitus among veterans who have past exposure to loud noise, and (2) accrue preliminary data examining the efficacy of the approach relative to standard care with education (ED) control conditions. Tinnitus was the most common service-connected disability among veterans 2006-2012. Interventions for tinnitus are few and no cure exists. This pilot study examined the feasibility and efficacy of providing individualized (CBT) for veterans with bothersome tinnitus. Twenty-five veterans were recruited and randomly selected to one of two conditions during Period One of the study; the treatment condition (CBT) or (ED) control. A CBT manual and an ED manual were developed for this study. Subjects were be eligible for the study if their tinnitus was likely caused by noise exposure, their tinnitus was chronic (> 6 months), tinnitus was a major health concern for them, and participants were able to commit to a 6-week course of treatment at the West Haven location of VACHS. Subjects were veterans blinded to the treatment group to which they are assigned if ED or CBT. The THI served as the primary outcome measure and the TRQ served as the secondary outcome measure pre- and post-treatment follow-up. Results of this pilot project were used to inform the design and methods of future rigorous randomized controlled clinical trials of CBT for tinnitus following its incorporation into the Progressive Tinnitus Management (PTM) protocol. Baseline and outcome data of the 4 participants who completed the study after this third arm was added to the study design are not reported as this third arm essentially modified the design such that a new study began but was not completed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All subjects were veterans who are currently receiving care at VACHS.

• Subjects were interested in participating in the study and had moderate to severe, chronic (>6 months) tinnitus.

• Following a brief assessment of tinnitus severity by the project coordinator, the research otologist and research audiologist conducted tinnitus and audiological evaluations to determine subject eligibility.

• The most likely etiology of subjects' tinnitus was noise exposure to and all eligible participants reported having been exposed to loud sound some time in their lives.

• Subjects indicated that they were motivated to comply with treatment and able to commit to a 6-week course of treatment, follow-up, and study participation by continuing to reside nearby.

• Subjects had stable, permanent housing and transportation means for follow-up appointments.

• Tinnitus was a significant health concern for all subjects.

• Women and minorities were recruited.

Exclusion Criteria:

• Subjects responded to five assessment measures to determine exclusion from the study.

• Tinnitus-Impact Screening Interview (TISI): Those who scored 4 or lower were excluded from the study.

• Semi-Structured Clinical Interview for Tinnitus: The exclusionary criteria described below were assessed using this measure.

• Structured Clinical Interview for Diagnosis, abbreviated - Interview/Non-patient (SCIDa-I/NP): If there was any indication of psychosis on this measure, the subject was excluded from the study.

• Tinnitus Handicap Inventory (THI): Subjects with scores of 19 or lower were excluded.

• Tinnitus Reaction Questionnaire (TRQ): Subjects who scored 16 or lower on this measure were excluded from the study.

• Subjects who were undergoing litigation or legal matters related to auditory disorders were excluded from the study.

• Subjects must never had previously received psychological treatment for their tinnitus.

• Subjects with otherwise treatable tinnitus were excluded.

• Subjects who had a history of psychotic disorders or dementia were excluded.

• These psychotic symptoms constituted exclusion from the study:

• delusions of reference

• persecutory delusions

• religious delusions

• grandiose delusions

• somatic delusions

• delusional guilt

• poverty or nihilism

• delusions of jealousy

• delusions of mind reading

• delusions of being controlled

• delusions of thought-broadcasting

• auditory hallucinations

• visual hallucinations

• tactile hallucinations

• gustatory and olfactory hallucinations

• Subjects who report having a recent (within 3-month) history of alcohol or drug abuse or dependence other than tobacco or caffeine were excluded.

• Subjects who presented with sudden or fluctuating hearing loss were excluded.

• Subjects with tinnitus associated with otologic disease (e.g., Meniere's Disease) or other co-occurring diseases affecting vestibular dysfunction were excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Behavioral:
• Cognitive Behavioral Therapy
A psychotherapeutic approach to tinnitus management which includes tinnitus education
• Tinnitus Education
An audiologic rehabilitative approach to tinnitus education.

Locations

Country	Name	City	State
United States	VA Connecticut Health Care System (West Haven)	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Handicap Inventory (THI)	Most widely used measure of tinnitus distress available during study period. The THI was created using the Tinnitus Handicap Questionnaire and the Tinnitus Questionnaire as well as the Beck Depression Inventory and Modified Somatic Perception Questionnaire. Its construct validity was also assessed using patients' responses on symptom rating scales and auditory tests of pitch and loudness. The THI score ranges from 0 to 100, with 100 indicating the most severe tinnitus and 0 is the least severe tinnitus. The authors of the THI have designated levels of severity, with scores of 16 and below falling into the "no handicap" range. This measure has strong internal consistency reliability (Cronbach's alpha = .93) and test-retest validity for the total score (r = .92). Significant improvement in tinnitus handicap can be observed with a 20-point change in total score.	pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks after session 1)	No
Secondary	Tinnitus Reaction Questionnaire (TRQ)	This is another commonly used measure of tinnitus distress in research. The TRQ is a global measure of tinnitus distress and was developed using correlations with clinician and self-report ratings of symptom categories. Scores on this measure range from 0 to 104 with higher scores indicating more distress. This measure has a high internal consistency reliability (Cronbach's alpha = .96) and test-retest validity for the total score (r = .88). Scores of 17 points or higher on this measure will indicate tinnitus severity is such that the patient is significantly disturbed by tinnitus. This is based on the use of the TRQ as a pre-test measure in measuring outcome of a controlled trial of CBT for tinnitus in an elderly sample. That study sample had an average TRQ score of 16.9 prior to treatment.	pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks later)	No