search
Back to results

A Comparison of Three Psychoeducational Group Interventions for Veterans With Tinnitus

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coping Effectiveness Training
Cognitive-behavioral therapy
Acceptance and Commitment Therapy
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, Coping, Psychoeducational intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Portland Health Care System, Portland, OR

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

No Intervention

Arm Label

Coping Effectiveness Training

Cognitive-behavioral therapy

Acceptance and Commitment Therapy

Wait-list control group

Arm Description

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 (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 (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 involves no intervention. This is a 'usual care' group.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
November 5, 2014
Last Updated
December 3, 2018
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT02293512
Brief Title
A Comparison of Three Psychoeducational Group Interventions for Veterans With Tinnitus
Official Title
A Comparison of CBT and CET Interventions for Veterans With Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
August 31, 2016 (Actual)
Study Completion Date
November 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Tinnitus, Coping, Psychoeducational intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coping Effectiveness Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive-behavioral therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Acceptance and Commitment Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Wait-list control group
Arm Type
No Intervention
Arm Description
Wait-list control group involves no intervention. This is a 'usual care' group.
Intervention Type
Behavioral
Intervention Name(s)
Coping Effectiveness Training
Other Intervention Name(s)
CET
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy
Other Intervention Name(s)
CBT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy
Other Intervention Name(s)
ACT
Intervention Description
An ACT psycho-educational intervention to reduce distress and resistance about having tinnitus and to increase committed actions based on one's values.
Primary Outcome Measure Information:
Title
Coping
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin C Martz, PhD
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.ncrar.research.va.gov/
Description
VAPORHCS National Center for Rehabilitative Auditory Research (NCRAR)

Learn more about this trial

A Comparison of Three Psychoeducational Group Interventions for Veterans With Tinnitus

We'll reach out to this number within 24 hrs