TinnitusNCT02293512
A Comparison of Three Psychoeducational Group Interventions for Veterans With Tinnitus
A study testing Coping Effectiveness Training, Cognitive-behavioral therapy and Acceptance and Commitment Therapy in people with Tinnitus, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Coping Effectiveness Training, Cognitive-behavioral therapy and Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 30 Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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:
- 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.
Who cannot join
- Development Phase (Phase 1)-focus groups:
- Not meeting inclusion criteria 1-6,
- nor have any other factor that would preclude full participation in the study.
- Testing Phase (Phase 2)-interventions:
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
About this study
Official title: A Comparison of CBT and CET Interventions for Veterans With Tinnitus
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.
Read the 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.
- Conditions
- Tinnitus
- Being tested
- Coping Effectiveness Training, Cognitive-behavioral therapy, Acceptance and Commitment Therapy
- Keywords
- Tinnitus, Coping, Psychoeducational intervention
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping Effectiveness TrainingBehavioural
Also called CET
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.
Cognitive-behavioral therapyBehavioural
Also called 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.
Acceptance and Commitment TherapyBehavioural
Also called ACT
An ACT psycho-educational intervention to reduce distress and resistance about having tinnitus and to increase committed actions based on one's values.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Coping Effectiveness Training |
| 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. Receives: Behavioral: Cognitive-behavioral therapy |
| 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. Receives: Behavioral: Acceptance and Commitment Therapy |
| Wait-list control group | No intervention | Wait-list control group involves no intervention. This is a 'usual care' group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study start1 Sep 2015
- Primary completion31 Aug 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Erin C Martz, PhD, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293512
- Sponsor's protocol ID
- C1578-P
- Other IDs
- RX001578
- Status last verified
- Dec 2018
- First submitted
- 5 Nov 2014
- Last updated
- 24 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of CBT and CET Interventions for Veterans With Tinnitus
- ClinicalTrials.gov ID
- NCT02293512
- Acronym / sponsor ID
- C1578-P
- Conditions
- Tinnitus
- Keywords
- Tinnitus, Coping, Psychoeducational intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 18 Nov 2014 (estimated)
- Results
- Posted 5 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Coping Effectiveness Training | Experimental | Behavioral: Coping Effectiveness TrainingCoping 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 | Behavioral: Cognitive-behavioral therapyCognitive-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 | Behavioral: Acceptance and Commitment TherapyAcceptance 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (7 listed)
- Not meeting inclusion criteria 1-6,
- nor have any other factor that would preclude full participation in the study.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping Effectiveness TrainingAlso: CETA 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. | Behavioural | Coping Effectiveness Training |
| Cognitive-behavioral therapyAlso: CBTCBT 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. | Behavioural | Cognitive-behavioral therapy |
| Acceptance and Commitment TherapyAlso: ACTAn ACT psycho-educational intervention to reduce distress and resistance about having tinnitus and to increase committed actions based on one's values. | Behavioural | Acceptance and Commitment Therapy |
Primary outcome
Coping
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- VAPORHCS National Center for Rehabilitative Auditory Research (NCRAR)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin C Martz, PhD principal investigator
VA Portland Health Care System, Portland, OR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping Effectiveness Training, Cognitive-behavioral therapy and Acceptance and Commitment Therapy in people with Tinnitus, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coping (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.