Tinnitus
Conditions
Keywords
Tinnitus, Coping, Psychoeducational intervention
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 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.
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 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.
Interventions
BEHAVIORALCoping Effectiveness Training
A CET psychoeducational intervention is provided 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.
BEHAVIORALCognitive-behavioral therapy
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.
BEHAVIORALAcceptance and Commitment Therapy
An ACT psycho-educational intervention to reduce distress and resistance about having tinnitus and to increase committed actions based on one's values.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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:
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coping | Baseline | The Brief COPE scale (Carver, 1997) is a widely-used 28-item short form of the COPE Inventory (Carver, Scheier et al., 1989). This instrument measures 14 coping subscales. Each item is scored using a 1-4 frequency scale (i.e., 1= I haven't been doing this it at all to 4= I've been doing this a lot), where higher scores reflect greater use of the coping strategy. A three-factor structure was used as follows: (a) Engagement coping (EC), including active coping, positive reframing, planning, accepting, and use of humor (items n = 12; score range 12-48); (b) disengagement coping (DC), including self-distancing, denial, behavioral disengagement, and self-blame (items n = 6; score range 6-24); and (c) social support coping (SS), including instrumenal support, emotional support, venting, and religion (items n = 8; score range 8-32). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Coping Effectiveness Training (CET) A 3-session intervention to facilitate coping strategies among individuals with tinnitus.
Coping Effectiveness Training for tinnitus: 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. | 10 |
| Cognitive-behavioral Therapy (CBT) A 3-session intervention to reduce negative affectivity triggered by tinnitus.
Cognitive-behavioral therapy (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. | 10 |
| Acceptance and Commitment Therapy 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: An ACT psycho-educational intervention to reduce distress and resistance about having tinnitus and to increase committed actions based on one's values. | 10 |
| Wait-list Control Group No intervention. This is a 'usual care' group. | 10 |
| Total | 40 |
Baseline characteristics
| Characteristic | Coping Effectiveness Training (CET) | Cognitive-behavioral Therapy (CBT) | Acceptance and Commitment Therapy | Wait-list Control Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 52.1 years STANDARD_DEVIATION 18.9 | 56.9 years STANDARD_DEVIATION 15.2 | 61.6 years STANDARD_DEVIATION 17.6 | 60.7 years STANDARD_DEVIATION 14.3 | 57.8 years STANDARD_DEVIATION 16.4 |
| Region of Enrollment United States | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 40 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 4 Participants | 1 Participants | 8 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 6 Participants | 9 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Coping
The Brief COPE scale (Carver, 1997) is a widely-used 28-item short form of the COPE Inventory (Carver, Scheier et al., 1989). This instrument measures 14 coping subscales. Each item is scored using a 1-4 frequency scale (i.e., 1= I haven't been doing this it at all to 4= I've been doing this a lot), where higher scores reflect greater use of the coping strategy. A three-factor structure was used as follows: (a) Engagement coping (EC), including active coping, positive reframing, planning, accepting, and use of humor (items n = 12; score range 12-48); (b) disengagement coping (DC), including self-distancing, denial, behavioral disengagement, and self-blame (items n = 6; score range 6-24); and (c) social support coping (SS), including instrumenal support, emotional support, venting, and religion (items n = 8; score range 8-32).
Time frame: Baseline
Population: Brief COPE 3 factors (engagement, disengagement, and social support)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coping Effectiveness Training (CET) | Coping | Engagement coping | 34.3 units on a scale | Standard Deviation 1.2 |
| Coping Effectiveness Training (CET) | Coping | Disengagement coping | 9.6 units on a scale | Standard Deviation 0.6 |
| Coping Effectiveness Training (CET) | Coping | Social support coping | 19.2 units on a scale | Standard Deviation 0.99 |
| Cognitive-behavioral Therapy (CBT) | Coping | Disengagement coping | 7.4 units on a scale | Standard Deviation 0.6 |
| Cognitive-behavioral Therapy (CBT) | Coping | Social support coping | 16.3 units on a scale | Standard Deviation 0.99 |
| Cognitive-behavioral Therapy (CBT) | Coping | Engagement coping | 31.6 units on a scale | Standard Deviation 1.2 |
| Acceptance and Commitment Therapy | Coping | Social support coping | 16.4 units on a scale | Standard Deviation 0.99 |
| Acceptance and Commitment Therapy | Coping | Engagement coping | 33.2 units on a scale | Standard Deviation 1.2 |
| Acceptance and Commitment Therapy | Coping | Disengagement coping | 8.7 units on a scale | Standard Deviation 0.6 |
| Wait-list Control Group | Coping | Social support coping | 14.9 units on a scale | Standard Deviation 0.99 |
| Wait-list Control Group | Coping | Engagement coping | 30.0 units on a scale | Standard Deviation 1.2 |
| Wait-list Control Group | Coping | Disengagement coping | 7.6 units on a scale | Standard Deviation 0.6 |