A Comparison of Three Psychoeducational Group Interventions for Veterans With Tinnitus
A Comparison of CBT and CET Interventions for Veterans With Tinnitus
2 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2014
CompletedFirst Posted
Study publicly available on registry
November 18, 2014
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2016
CompletedResults Posted
Study results publicly available
November 5, 2018
CompletedDecember 24, 2018
December 1, 2018
1 year
November 5, 2014
August 23, 2017
December 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Coping Effectiveness Training
EXPERIMENTALCoping 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 COMPARATORCognitive-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 COMPARATORAcceptance 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 INTERVENTIONWait-list control group involves no intervention. This is a 'usual care' group.
Interventions
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.
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.
An ACT psycho-educational intervention to reduce distress and resistance about having tinnitus and to increase committed actions based on one's values.
Eligibility Criteria
You may qualify if:
- Development Phase (Phase 1)-focus groups:
- \) Veterans;
- \) have chronic tinnitus that is sufficiently bothersome to warrant intervention-see below for explanation;
- \) able to communicate in English;
- \) willing and able to give written informed consent;
- \) use hearing aids if needed; and
- \) have participated in the PTM program at the VA Portland Healthcare System.
- Testing Phase (Phase 2)-interventions:
- \) Veterans and civilians;
- \) have a score of at least 25 on the Tinnitus Functional Index (\[TFI\]; Meikle, J.A. Henry, et al., 2012);
- \) have two errors or less on a six-item cognitive screening instrument (Callahan, Unverzagt, Hui, Perkins, \& Hendrie, 2002);
- \) able to communicate in English;
- \) willing and able to give written informed consent; and
- \) use hearing aids if needed.
You may not qualify if:
- Development Phase (Phase 1)-focus groups:
- nor have any other factor that would preclude full participation in the study.
- Testing Phase (Phase 2)-interventions:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Erin Martz, PhD
- Organization
- VA Portland Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Erin C Martz, PhD
VA Portland Health Care System, Portland, OR
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2014
First Posted
November 18, 2014
Study Start
September 1, 2015
Primary Completion
August 31, 2016
Study Completion
November 30, 2016
Last Updated
December 24, 2018
Results First Posted
November 5, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share