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

Cognitive Behaviour Therapy (CBT) for Tinnitus Treatment: Implementation and Validity

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

Study Overview

• Status: Completed
• Conditions: Tinnitus, Subjective
• Intervention / Treatment: Behavioral: CBT 1; Behavioral: CBT 2

• Study Type: Observational
• Enrollment (Actual): 403

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with tinnitus

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Step 1 only; Participants in the study who only receive Step 1 of specialised CBT	Behavioral: CBT 1; 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; Participants who receive both Step 1 and Step 2 of speciliased CBT for tinnitus.	Behavioral: CBT 1; 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).; Behavioral: CBT 2; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tinnitus Handicap Inventory (THI)	The THI (Newman, Jacobson, & Spitzer, 1996; Newman, Sandridge, & Jacobson, 1998).is a 25 items measure of the impact of tinnitus on daily life that includes three subscales. The subscales cover functional (mental, social/occupational and physical functioning), emotional impact and catastrophic responses to tinnitus.	12 months
Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983).	The HADS is a widely used measure of psychological distress in people experiencing a concurrent physical health condition. It has 14 items and respondents use a Likert-type scale to indicate how often they have had a particular feeling in the previous week (e.g. "I feel tense or wound up").	12 months
Tinnitus Catastrophizing Scale (TCS)	Tinnitus Catastrophizing Scale (TCS; Cima, Crombez, & Vlaeyen, 2011). The TCS was used to assess the degree to which people thought or expected the worst about tinnitus (i.e. catastrophizing). The TCS is a 13-item measure based on the Pain Catastrophizing Scale (Sullivan, Bishop, & Pivik, 1995) and respondents use a five point scale to indicate the degree to which statements applies to them (e.g. It's terrible and I think it's never going to get any better). The total score on the TCS ranges from 0 to 65.	12 months
Fear of Tinnitus Questionnaire (FTQ)	The FTQ is a 17-item self-report measure intended and designed to assess respondents' level of fear regarding their tinnitus. Items in the questionnaire are presented as a series of statements (e.g. "I am afraid that my tinnitus will become worse") from which respondents are asked to indicate if it is applicable to their current situation. Each statement receives a score of 1 when applicable. The total score is the sum of all applicable statements and provides an overall rating of fear of tinnitus and ranges from 0 to 17.	12 months
Tinnitus Questionnaire (TQ)	The Tinnitus Questionnaire (TQ; Hallam, Jakes, & Hinchcliffe, 1988) is a self-report questionnaire designed to asses distress and interference in daily activities that is associated with tinnitus. It has 52 items and uses a three-point scale to indicate levels of distress on six subscales. The total possible score on the TQ ranges from 0-84.	12 months
Tinnitus Disability Index (TDI)	The Tinnitus Disability Index (TDI; Cima, Vlaeyen, Maes, Joore, & Anteunis, 2011) is a seven-item self-report questionnaire that assesses the level of interferences in daily activities (such as occupational, social, and recreational) attributed to tinnitus. Respondents use an 11-point scale to indicate the level of interference ranging from 0 no disability, to 10 total disability. The total score ranges from 0 to 70 with higher scores indicating higher levels of interference.	12 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): November 16, 2016
• Study Completion (Actual): November 16, 2016

Study Registration Dates

• First Submitted: March 13, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: CBT; tinnitus; cognitive behaviour therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: ECP-152 05_12_2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No