Status:
COMPLETED
A Comparison of Three Psychoeducational Group Interventions for Veterans With Tinnitus
Lead Sponsor:
VA Office of Research and Development
Conditions:
Tinnitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed 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...
Eligibility Criteria
Inclusion
- Development Phase (Phase 1)-focus groups:
- Inclusion criteria are the following (more details are provided below):
- 1\) Veterans;
- 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 VA Portland Healthcare System.
- 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
- 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.
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02293512
Start Date
September 1 2015
End Date
November 30 2016
Last Update
December 24 2018
Active Locations (1)
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1
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239