Ignite Creation Date:
2024-05-05 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 9:52 AM
Study NCT ID:
NCT00724152
Status:
COMPLETED
Last Update Posted:
2015-05-06
First Post:
2008-07-23
Brief Title:
Cognitive Behavioral Therapy CBT for Tinnitus
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Cognitive-behavioral Therapy for Tinnitus
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study examined how useful it is to teach veterans coping skills for dealing with tinnitus also called ringing in the ears A psychological intervention cognitive-behavioral therapy was used to teach coping skills even though tinnitus is not a psychological disorder Participants in Period 1 of the study were assigned to one of two groups for the duration of the study and were blinded to their group assignment until the end of the study One group received education about tinnitus The other group received education about tinnitus plus additional ways to cope with problems associated with tinnitus such as sleep disturbance and frustration Participants were selected to participate if their tinnitus was severe and they had been exposed to loud sound Participants attended up to six weekly group meetings It was predicted that participants who were randomly assigned to the cognitive behavioral therapy group would report a greater reduction in tinnitus severity than education controls During Period 2 of the study a third standard care arm was added Baseline and outcome data of the 4 participants who completed the study after this third arm was added to the study design are not reported
Detailed Description:
The objectives of this study were to 1 develop a novel integrative psychological intervention specifically cognitive-behavioral therapy CBT for the treatment of tinnitus among veterans who have past exposure to loud noise and 2 accrue preliminary data examining the efficacy of the approach relative to standard care with education ED control conditions Tinnitus was the most common service-connected disability among veterans 2006-2012 Interventions for tinnitus are few and no cure exists This pilot study examined the feasibility and efficacy of providing individualized CBT for veterans with bothersome tinnitus Twenty-five veterans were recruited and randomly selected to one of two conditions during Period One of the study the treatment condition CBT or ED control A CBT manual and an ED manual were developed for this study Subjects were be eligible for the study if their tinnitus was likely caused by noise exposure their tinnitus was chronic 6 months tinnitus was a major health concern for them and participants were able to commit to a 6-week course of treatment at the West Haven location of VACHS Subjects were veterans blinded to the treatment group to which they are assigned if ED or CBT The THI served as the primary outcome measure and the TRQ served as the secondary outcome measure pre- and post-treatment follow-up Results of this pilot project were used to inform the design and methods of future rigorous randomized controlled clinical trials of CBT for tinnitus following its incorporation into the Progressive Tinnitus Management PTM protocol Baseline and outcome data of the 4 participants who completed the study after this third arm was added to the study design are not reported as this third arm essentially modified the design such that a new study began but was not completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None