N/A
N=40
A Comparison of Three Psychoeducational Group Interventions for Veterans With Tinnitus
Tinnitus
Bottom Line
View on ClinicalTrials.gov: NCT02293512 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Coping — 34.3; 31.6; 33.2; 30.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Coping Effectiveness Training (Behavioral); Cognitive-behavioral therapy (Behavioral); Acceptance and Commitment Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Coping |
34.3; 31.6; 33.2; 30.0; 9.6; 7.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT02293512). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.