A Comparison of Three Psychoeducational Group Interventions for Veterans With Tinnitus

Completed · Not applicable

Conditions studied: Tinnitus

In brief

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.

Key facts

Study ID

NCT02293512

Run by

VA Office of Research and Development

People needed

40

Starts

2015-09-01

Expected to finish

2016-11-30

Last updated by the study team

2018-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• VA Portland Health Care System, Portland, OR — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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