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| ID | Type | Description | Link |
|---|---|---|---|
| RX001578 | Other Grant/Funding Number | VA RR&D |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coping Effectiveness Training | Experimental | Coping Effectiveness Training (CET) is provided in a 3-session intervention to facilitate coping strategies among individuals with tinnitus. The CET psychoeducational intervention teaches coping skills to increase understanding of stress and coping with tinnitus, and to help individuals better know how to match appropriate coping strategies, based on whether the stressful situation is changeable or not. |
|
| Cognitive-behavioral therapy | Active Comparator | Cognitive-behavioral therapy (CBT) is provided in a 3-session psychoeducational intervention to reduce negative affectivity triggered by tinnitus. 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. |
|
| Acceptance and Commitment Therapy | Active Comparator | Acceptance and Commitment Therapy (ACT) is provided in a 3-session psychoeducational intervention to decrease resistance to tinnitus and increase committed action based on values, despite having tinnitus. |
|
| Wait-list control group | No Intervention | Wait-list control group involves no intervention. This is a 'usual care' group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coping Effectiveness Training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline |
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Inclusion Criteria:
Development Phase (Phase 1)-focus groups:
Inclusion criteria are the following (more details are provided below):
Testing Phase (Phase 2)-interventions:
Inclusion criteria are the following:
Exclusion Criteria:
Development Phase (Phase 1)-focus groups:
Exclusion criteria are:
Testing Phase (Phase 2)-interventions:
Exclusion criteria are:
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| Name | Affiliation | Role |
|---|---|---|
| Erin C Martz, PhD | VA Portland Health Care System, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97239 | United States |
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| Label | URL |
|---|---|
| VAPORHCS National Center for Rehabilitative Auditory Research (NCRAR) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | Wait-list Control Group | No intervention. This is a 'usual care' group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Brief COPE 3 factors (engagement, disengagement, and social support) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
2015-2016: one year of data collection.
The Clinicaltrials.gov definition (i.e., "Any untoward or unfavorable medical occurrence in a participant...temporally associated with the participant's participation in the research...") was used. Given that the interventions were psychological, the data related to medical events were not collected by the research team; if any such medical events had been self-reported by participants, then the data will be reported to the Institutional Review Board and on the Clinicaltrials.gov website).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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One limitation was that only self-report instruments were used, and therefore, social desirability may have influenced the results. Further, while this study involved repeated measures, the sample was small and thus the results should be replicated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Martz, PhD | VA Portland Healthcare System | 503.220.8262 | 56006 | erin.martz@va.gov |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
|
| Cognitive-behavioral therapy | Behavioral | 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. |
|
|
| Acceptance and Commitment Therapy | Behavioral | An ACT psycho-educational intervention to reduce distress and resistance about having tinnitus and to increase committed actions based on one's values. |
|
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Wait-list Control Group | No intervention. This is a 'usual care' group. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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. |
| OG001 | 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. |
| OG002 | 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. |
| OG003 | Wait-list Control Group | No intervention. This is a 'usual care' group. |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Wait-list Control Group | No intervention. This is a 'usual care' group. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |