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Completed

NCT Number: NCT04310605

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

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

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

  1. Health Utilities Index-III

    Time frame: 12 months

    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.

Secondary outcomes

  1. Tinnitus Handicap Inventory (THI)

    Time frame: 12 months

    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.

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

    Time frame: 12 months

    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").

  3. Tinnitus Catastrophizing Scale (TCS)

    Time frame: 12 months

    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.

  4. Fear of Tinnitus Questionnaire (FTQ)

    Time frame: 12 months

    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.

  5. Tinnitus Questionnaire (TQ)

    Time frame: 12 months

    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.

  6. Tinnitus Disability Index (TDI)

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Maastricht University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2020
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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