Effectiveness of Specialised Cognitive Behavioural Therapy (CBT) for Tinnitus.

NCT04310605 | Completed

• 1 other identifier: ECP-152 05_12_2014
• Study Type: observational
• Target: 403
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an observational study of specialised CBT for tinnitus for adults delivered in routine care.

Conditions

Tinnitus, Subjective

Keywords

tinnitus; CBT; cognitive behaviour therapy

Outcome Measures

Primary Outcomes (1)

• Health Utilities Index-III

  The Health Utilities Index (HUI; Feeny et al., 2002; Horsman, Furlong, Feeny, \& Torrance, 2003) is a 17-item measure designed to assess health related quality of life.

  12 months

Secondary Outcomes (6)

• Tinnitus Handicap Inventory (THI)

  12 months

• Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983).

  12 months

• Tinnitus Catastrophizing Scale (TCS)

  12 months

• Fear of Tinnitus Questionnaire (FTQ)

  12 months

• Tinnitus Questionnaire (TQ)

  12 months

Study Arms (2)

Step 1 only

Participants in the study who only receive Step 1 of specialised CBT

Behavioral: CBT 1

Step 1 and 2

Participants who receive both Step 1 and Step 2 of speciliased CBT for tinnitus.

Behavioral: CBT 1; Behavioral: CBT 2

Interventions

CBT 1 BEHAVIORAL

CBT for tinnitus (Step 1) comprised: individual audiometric assessment, and counselling about hearing and tinnitus (1hr) with an audiologist; a one-off educational group session (a max 10 participants and partners) (2hrs); an assessment session with a psychologists (1 hr).

Step 1 and 2; Step 1 only

CBT 2 BEHAVIORAL

Step 2 group sessions were 2 hrs long over a 12-week period. Two therapists (a psychologist and physiotherapist) were present at any one time for Step 2 sessions. Step 2 included: psycho-education; exposure therapy; mindfulness exercises; cognitive restructuring; attention redirecting techniques; stress reduction; and, relaxation techniques. Evening sessions were also provided for participants to attend with family or partners.

Step 1 and 2

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with tinnitus

You may qualify if:

• Tinnitus is the primary complaint and reason for seeking help
• Participant is at least 17 years of age,

You may not qualify if:

• Unable to read and write in Dutch
• Tinnitus is not the primary complaint
• Person is under 17 years of age
• Participant has a health condition that prevents them from attending treatment centre
• An Ear Nose Throat (ENT) physician assesses the participant as having ontological condition that requires medical treatment

Sponsors & Collaborators

• Maastricht University: lead
• SWOL Limburgs Fonds voor Revalidatie: collaborator
• Flemish Government, Belgium: collaborator
• The Netherlands Organization for Scientific Research (NWO): collaborator
• Libra Revalidatie en Audiologie: collaborator

Related Publications (1)

• Cima RF, Maes IH, Joore MA, Scheyen DJ, El Refaie A, Baguley DM, Anteunis LJ, van Breukelen GJ, Vlaeyen JW. Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial. Lancet. 2012 May 26;379(9830):1951-9. doi: 10.1016/S0140-6736(12)60469-3.

  PMID: 22633033 BACKGROUND

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2020
• First Posted: March 17, 2020
• Study Start: January 1, 2014
• Primary Completion: November 16, 2016
• Study Completion: November 16, 2016
• Last Updated: March 17, 2020

Record last verified: 2020-03