Hearing Impairment, Cognitive Therapy and Coping

NCT01206829 | Unknown Phase 1

• 2 other identifiers: 2009/2156 (REK)52-2009 AUS
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss; Tinnitus; Stress, Psychological; Mental Fatigue

Keywords

Hearing Impaired Persons; Tinnitus; Life Change Events; Adaptation, Psychological; Rehabilitation, Vocational; Cognitive Therapy; Avoidance Learning; Escape Reaction

Outcome Measures

Primary Outcomes (4)

• Work Ability Index

  Work Ability Index is a self report instrument that measures changes and variations in level of vocational functioning.

  At recruitment, at time of course completement and at 6 months post-treatment

• Current employment status

  Participants are asked to desribe their current vocational situation in some more detail. In addition, one item from the General Health Questionnaire, GQH-20 (World Health Organization, 2007) is included here: "To what degree is your ability to perform your ordinary work reduced today?"

  At recruitment, at time of course completement and at 6 months post-treatment.

• Hospital Anxiety and Depression Scale; HADS

  HADS consists of 14 items covering symptoms of anxiety and depression. HADS is a standarized and validated self report measure of general, mental health.

  At recruitment, at time of course completement and at 6 months post-treatment.

• Fear of Negative Evaluation (FNE)

  FNE is a self report questionnaire covering symptoms of social phobia. FNE is often used to measure treatment outcome.

  At recruitment, at time of course completement and at 6 months post-treatment.

Study Arms (1)

Audiological rehabilitation

ACTIVE COMPARATOR

16 hours of psychosocial rehabilitation course

Behavioral: 8-session CBTcourse; Behavioral: 8 session cognitive behavioral therapy

Interventions

8-session CBTcourse BEHAVIORAL

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.

Audiological rehabilitation

8 session cognitive behavioral therapy BEHAVIORAL

8 sessions cognitive behavioral therapy in group

Audiological rehabilitation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• South-Eastern Norway Regional Health Authority: collaborator
• National Centre for Hearing Impairment and Mental Health: collaborator

Study Sites (1)

The Norwegian Centre for Hearing Impairment and Mental Health Oslo University Hospital

Oslo, Norway, 0424, Norway

Location

MeSH Terms

Conditions

Hearing Loss; Tinnitus; Stress, Psychological; Mental Fatigue; Escape Reaction

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Fatigue; Taxis Response; Behavior, Animal; Orientation, Spatial; Spatial Behavior

Study Officials

• Egil W Martinsen, Prof. dr. med.

  Oslo University Hospital

  STUDY CHAIR

• Katharine C Williams, cand. psychol.

  The Norwegian Centre for Hearing Impairment and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 22, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: June 14, 2013

Record last verified: 2013-06

Locations

NO (1)