Ignite Creation Date:
2024-05-05 @ 10:52 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01206829
Status:
UNKNOWN
Last Update Posted:
2013-06-14
First Post:
2010-09-21
Brief Title:
Hearing Impairment Cognitive Therapy and Coping
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Hearing Impairment Tinnitus Mental Health and Vocational Coping A Randomized Controlled Study of a Cognitive Therapy Program to Reduce Social Safety Seeking
Status:
UNKNOWN
Status Verified Date:
2013-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
A randomized controlled study with hearing impaired workers who have voluntarily signed up for an 8 session cognitive therapy CBT course The CBT intervention will be compared to a waiting list control group Participants who are allocated to the intervention group will be offered to start on the CBT-course immediately while the control group that will be offered the same course 12 months later Main outcome measures are assessments of mental distress and vocational coping We will also assess the distress associated with tinnitus which is a potential moderator variable
Detailed Description:
Although the relationship between hearing loss and mental distress is not linear it is known that hearing impaired individuals have increased vulnerability for development of symptoms of distress and fatigue It is assumed that distressed hearing impaired individuals will have a tendency to use maladaptive and passive coping strategies such as social withdrawal or reluctance to make use of hearing aid devices On the other side it is well documented that hearing impaired employers who are open about their handicap and make others aware of their situation ie take an active coping approach have fewer symptoms of distress and have better vocational functioning The level of knowledge is limited and mainly based on cross sectional studies and the way people cope with hearing impairment has been measured indirectly by questionnaires focusing on communication problems We plan to conduct a randomized controlled study with hearing impaired workers who have voluntarily signed up for an 8 session cognitive therapy CBT course The CBT intervention will be compared to a waiting list control group Participants who are allocated to the intervention group will be offered to start on the CBT-course immediately while the control group that will be offered the same course 12 months later Main outcome measures are assessments of mental distress and vocational coping We will also assess the distress associated with tinnitus which is a potential moderator variable
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 52-2009 AUS | OTHER | Kompetansesenter for personvern og sikkerhet OUS | None |