A Comparison of Three Psychoeducational Group Interventions for Veterans With Tinnitus

Tinnitus Clinical Trial

Official title:

A Comparison of CBT and CET Interventions for Veterans With Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02293512
• Other study ID #: C1578-P
• Secondary ID: RX001578
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: November 30, 2016

Study information

• Verified date: December 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 30, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tinnitus

Intervention

Behavioral:
• Coping 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.
• Cognitive-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.
• Acceptance 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.

Locations

Country	Name	City	State
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline

External Links

•   VAPORHCS National Center for Rehabilitative Auditory Research (NCRAR)