Cognitive Behavioral Therapy (CBT) for Tinnitus

NCT00724152 | Completed Phase 1 Results

• 1 other identifier: C6324-P
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tinnitus

Keywords

coping skills; psychology; audiology; veterans; tinnitus; adult; intervention studies; tinnitus, noise induced; noise; auditory perception

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Tinnitus Reaction Questionnaire (TRQ)

  pre-treatment (session 1) to post-treatment (session 6; approximately 6 weeks later)

Study Arms (3)

Arm 1/Cognitive Behavioral Therapy

EXPERIMENTAL

Participants randomly assigned to this experimental group received six weeks of tinnitus education plus cognitive behavioral therapy. Cognitive behavioral therapy for tinnitus participants addressed cognitive and behavioral skills targeting the management of tinnitus and the negative impacts of tinnitus. Long-term self-efficacy and self-sufficiency were emphasized. The major components of CBT for tinnitus included identification of individual responses and beliefs about tinnitus and hearing loss, re-conceptualization of the tinnitus experience as one in which the patient has personal control, presentation of skills to modify cognitions and change behaviors, and reinforcement of skills via goals setting, homework and activities. Skills related to attention control, sleep hygiene, relaxation training are provided. Tinnitus education also included causes, treatments, current research, etc.

Behavioral: Cognitive Behavioral Therapy

Arm 2/Tinnitus Education

ACTIVE COMPARATOR

Participants randomly assigned to this group received six weeks of tinnitus education. Tinnitus education and skills related to attention control, sleep hygiene and relaxation training such as imagery techniques were provided. Tinnitus education included causes, treatments, current research, epidemiological information, basic anatomy of the ear and brain, and support resources.

Behavioral: Tinnitus Education

Arm 3/Standard Care

NO INTERVENTION

Participants randomly assigned to this control group received only standard care. Standard care involves audiological measurement and brief education during the standard care appointment.

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

A psychotherapeutic approach to tinnitus management which includes tinnitus education

Also known as: CBT

Arm 1/Cognitive Behavioral Therapy

Tinnitus Education BEHAVIORAL

An audiologic rehabilitative approach to tinnitus education.

Arm 2/Tinnitus Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Tinnitus-Impact Screening Interview (TISI): Those who scored 4 or lower were excluded from the study.
• 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.
• delusions of reference
• persecutory delusions
• religious delusions
• grandiose delusions
• somatic delusions
• delusional guilt
• poverty or nihilism

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• Yale University: collaborator

Study Sites (1)

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

During Period 2 only two participants (one completer) were randomized to "standard care" and only four participants (3 completers) were randomized "Cognitive Behavioral Therapy."

Results Point of Contact

• Title: Dr. Caroline Schmidt, Co-investigator
• Organization: VA Connecticut Healthcare System

Caroline.Schmidt@va.gov

203-932-5711

Study Officials

• Robert D. Kerns, PhD

  VA Connecticut Health Care System (West Haven)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: July 29, 2008
• Study Start: February 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: May 6, 2015
• Results First Posted: April 17, 2015

Record last verified: 2015-04

Locations

US (1)