Overview

This trial is active, not recruiting.

Condition tinnitus
Treatments coping effectiveness training for tinnitus, cognitive-behavioral therapy (cbt), acceptance and commitment therapy for tinnitus
Sponsor VA Office of Research and Development
Start date September 2015
End date August 2016
Trial size 80 participants
Trial identifier NCT02293512, C1578-P, RX001578

Summary

Tinnitus (i.e., ringing in the ears) is currently the most prevalent disability among Veterans. A range of clinical interventions has been created to systematically address the range of issues caused by tinnitus. While numerous interventions purport to promote coping strategies for tinnitus-related problems, few studies directly target and measure coping outcomes. The present pilot study proposes a comparison of coping outcomes after 3 psycho-educational groups: a cognitive-behavioral therapy (CBT) intervention, a Coping Effectiveness Training (CET) intervention, or an Acceptance and Commitment Therapy intervention among Veterans with tinnitus. These groups will be compared to a usual care group among Veterans and civilians with tinnitus. The proposed study will be the first application of CET to tinnitus. The primary goals of this study are to develop a CET protocol for tinnitus and to evaluate the effectiveness of CBT, CET, and ACT interventions to a usual care group. The long-term goal of this study is to improve the quality of life among individuals with tinnitus.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
A 3-session intervention to facilitate coping strategies among individuals with tinnitus.
coping effectiveness training for tinnitus CET
A CET psycho-educational intervention to increase understanding of stress and coping with tinnitus, and to better learn how to match appropriate coping strategies, based on whether the stressful situation is changeable or not.
(Active Comparator)
A 3-session intervention to reduce negative affectivity triggered by tinnitus.
cognitive-behavioral therapy (cbt) CBT
CBT treatments for tinnitus target the reduction of psychopathology by altering cognitive distortions, automatic thoughts, and core beliefs, as well as behavioral techniques to reduce physiological arousal.
(Active Comparator)
A 3-session intervention to decrease resistance to tinnitus and increase committed action based on values, despite having tinnitus.
acceptance and commitment therapy for tinnitus ACT
An ACT psycho-educational intervention to reduce distress and resistance about having tinnitus and to increase committed actions based on one's values.
(No Intervention)
No intervention. This is a 'usual care' group.

Primary Outcomes

Measure
Coping
time frame: Up to 2 years
Coping with tinnitus
time frame: Up to 2 years
Tinnitus Functional Index
time frame: Up to 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Development Phase (Phase 1)-focus groups: Inclusion criteria are the following (more details are provided below): - 1) PVAMC patients; - 2) have chronic tinnitus that is sufficiently bothersome to warrant intervention-see below for explanation; - 3) able to communicate in English; - 4) willing and able to give written informed consent; - 5) use hearing aids if needed; and - 6) have participated in the PTM program at the PVAMC. Testing Phase (Phase 2)-interventions: Inclusion criteria are the following: - 1) Veterans and civilians; - 2) have a score of at least 25 on the Tinnitus Functional Index ([TFI]; Meikle, J.A. Henry, et al., 2012); - 3) have two errors or less on a six-item cognitive screening instrument (Callahan, Unverzagt, Hui, Perkins, & Hendrie, 2002); - 4) able to communicate in English; - 5) willing and able to give written informed consent; and - 6) use hearing aids if needed. Exclusion Criteria: Development Phase (Phase 1)-focus groups: Exclusion criteria are: - Not meeting inclusion criteria 1-6, - nor have any other factor that would preclude full participation in the study. Testing Phase (Phase 2)-interventions: Exclusion criteria are: - Not meeting inclusion criteria 1-6, - having participated in the PTM program or Phase 1 of this study, - or having any other factor that would preclude full participation in the study. Recruitment for Phase 2 will begin in year 1 once the CET protocol is finalized.

Additional Information

Official title A Comparison of CBT and CET Interventions for Veterans With Tinnitus
Principal investigator Erin C Martz, PhD
Description Tinnitus (i.e., ringing in the ears) is currently the most prevalent disability in the VA system. Numerous clinical interventions have been created to systematically address the range of issues caused by tinnitus. Only a few tinnitus interventions have focused on coping strategies. Coping strategies are cognitive, affective, and behavioral attempts to master new events, such as the onset of a disability or an impairment like tinnitus, that are overwhelming to an individual, and that because of their newness, an individual does not necessarily have automatic, adaptive responses. Evidence suggests that CET is effective in facilitating adaptive coping strategies among individuals with several types of impairments or disabilities. The proposed study will be the first application of CET to a tinnitus population. The present study proposes a development of a CET protocol for tinnitus and a pilot study that assesses the effectiveness of the CET and ACT interventions compared to the current clinical practice of using a CBT intervention. All 3 psycho-educational interventions will be compared to a usual care group. The overarching goal of the proposed pilot study is to gain information that can be used to provide individuals with tinnitus with the best care for helping them to more successfully cope with tinnitus. The aims of this research are to: 1) develop a CET protocol for tinnitus by means of information gathered from two focus groups and from CET consultants; 2) to examine whether a 3-session CET psycho-educational intervention is more effective than a 3-session CBT psycho-educational intervention or a 3-session ACT psycho-educational intervention, as compared to a usual care, in increasing coping strategies among individuals with tinnitus.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.