Overview

This trial is active, not recruiting.

Conditions hearing loss, tinnitus, stress, psychological, mental fatigue
Treatments 8-session cbtcourse, 8 session cognitive behavioral therapy
Phase phase 1
Sponsor Oslo University Hospital
Collaborator South-Eastern Norway Regional Health Authority
Start date October 2010
End date December 2012
Trial size 180 participants
Trial identifier NCT01206829, 2009/2156 (REK), 52-2009 AUS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
16 hours of psychosocial rehabilitation course
8-session cbtcourse
Hearing impaired workers voluntarily sign up for an 8 session cognitive therapy course. The study has a waiting list control group design. Participants will be randomized assigned to either an experiment group that will be offered to start on an immediate course, or a control group that will be offered the same course 12 months later.
8 session cognitive behavioral therapy
8 sessions cognitive behavioral therapy in group

Primary Outcomes

Measure
Work Ability Index
time frame: At recruitment, at time of course completement and at 6 months post-treatment
Current employment status
time frame: At recruitment, at time of course completement and at 6 months post-treatment.
Hospital Anxiety and Depression Scale; HADS
time frame: At recruitment, at time of course completement and at 6 months post-treatment.
Fear of Negative Evaluation (FNE)
time frame: At recruitment, at time of course completement and at 6 months post-treatment.

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Eligible participants need to be within the age range of 18-70 years, contain some formal employment and be able to document a mean, bilateral hearing loss of at least 40 dB. - Eligible participants need to have a HAD score of 7 or beyond Exclusion Criteria: - Individuals without a clear vocational status (for instance on permanent/temporarily sick leave) and a mean bilateral hearing loss beneath 40 dB. - Individuals with a HAD score beneath 8 are excluded.

Additional Information

Official title Hearing Impairment, Tinnitus, Mental Health and Vocational Coping. A Randomized, Controlled Study of a Cognitive Therapy Program to Reduce Social Safety Seeking.
Principal investigator Katharine C Williams, cand. psychol.
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, i.e. 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Oslo University Hospital.