The CATT Trial: Cost-effectiveness of a Smartphone Application for Tinnitus Treatment

NCT05245318 | Recruiting DMC

• 1 other identifier: T002221N
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

Brief Summary

The twofold aim of this single-blind two-arm 1:1 randomised control trial is to examine if the treatment effect and cost-effectiveness of a smartphone application, designed to increase therapy compliance and provide tinnitus counselling, as part of a blended physiotherapy program, is, as hypothesised, as good as or better in comparison to standard clinical care.

Conditions

Tinnitus

Keywords

somatic tinnitus; smartphone application; telerehabilitation; blended physiotherapy program

Outcome Measures

Primary Outcomes (1)

• Change in Tinnitus Functional Index (TFI)

  The primary outcome is the change in Tinnitus functional index (TFI) score from baseline to one month after the treatment. This timepoint was chosen since previous research indicated that the largest treatment effect on TFI is to be expected four to seven weeks after the last treatment session. The TFI is a self-report questionnaire comprising 25 questions, each scored by an eleven-point Likert scale, objectifying the impact and severity of tinnitus. Eight subscores are differentiated, namely intrusiveness, sense of control, cognitive complaints, sleep disturbance, auditory difficulties, relaxation, quality of life (QOL) and emotional distress. The total score and subscores are noted on a scale of 0 to 100. Higher scores indicate higher levels of tinnitus-related distress. TFI has a good test-retest reliability (r: 0.78), discriminant validity with the Beck Depression Inventory-Primary Care (r: 0.56) and convergent validity with the Tinnitus Handicap Inventory (THI) (r: 0.86).

  from baseline to one month follow-up (also tested after last treatment session and at three months follow-up)

Secondary Outcomes (19)

• Cervical spine mobility

  from baseline to one and three months follow-up

• Joint Repositioning Accuracy (JRA)

  from baseline to one and three months follow-up

• Strength of deep neck flexors

  from baseline to one and three months follow-up

• Coordination of deep neck extensors

  from baseline to one and three months follow-up

• Coordination of shoulder stabilizing muscles

  from baseline to one and three months follow-up

Study Arms (2)

Standard clinical care control group

ACTIVE COMPARATOR

Standard physiotherapy program of 12 weeks (1 treatment session /week)

Other: Standard Clinical care

Experimental blended physiotherapy program group

EXPERIMENTAL

Blended physiotherapy program of 12 weeks with exercises and counselling provided through a smartphone application and 6 face-to-face treatment sessions (1 physiotherapy treatment session every 2 weeks)

Device: Blended physiotherapy program

Interventions

Standard Clinical care OTHER

The standard care treatment comprises 12 face-to-face individual physiotherapy sessions at a ratio of 1 session a week. Every patient in the control group will be treated in a tailored manner according to their results on the baseline measurements. The multimodal treatment program will consist of exercises to increase strength, endurance and coordination of the cervical spine and shoulder stabilising muscles, exercises to increase mobility and improve posture. In case of jaw complaints stretching exercises of the masticatory muscles are added to the program. In addition, manual mobilisations and manual techniques to decrease muscle tension in neck and jaw muscles can be added to the exercise program if necessary. Patients will receive counselling to learn about their neck/jaw complaints but no tinnitus counselling. Patients will be motivated to perform the exercise program at home on a daily basis. Patients will be evaluated weekly.

Standard clinical care control group

Blended physiotherapy program DEVICE

The experimental group will receive a blended physiotherapy program consisting of six physiotherapy treatments over a period of 12 weeks, meaning one treatment session every two weeks. In addition, a smartphone application will offer the patients a daily exercise program, based upon the standard physiotherapy treatment, and psychological counselling. Before the start of the program, the exercises will be tailored to the area, type and degree of the patient's dysfunctions. During the six physiotherapy treatment sessions patients will (if needed), receive additional manual mobilisations to increase mobility of the neck and/or temporomandibular joints or manual techniques to decrease muscle tension in neck and jaw muscles. Additional counselling on knowledge about neck and jaw pain and advice about good posture and movement habits will also be provided by the physiotherapist during these six treatment sessions.

Experimental blended physiotherapy program group

Eligibility Criteria

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

You may qualify if:

• Adults (+ 18 years old) with Somatic tinnitus (ST), diagnosed according to the diagnostic criteria for ST
• Fluent in Dutch
• Own smartphone and able to use common applications without support

You may not qualify if:

• Other types of tinnitus
• Active middle ear pathology
• An active psychiatric disorder (such as anxiety disorder or clinical depression) diagnosed by the psychiatric team of Antwerp University Hospital

Sponsors & Collaborators

• Hasselt University: lead
• Universiteit Antwerpen: collaborator
• University Hospital, Antwerp: collaborator
• University of Regensburg: collaborator

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

Related Publications (1)

• Demoen S, Jacquemin L, Timmermans A, Van Rompaey V, Vanderveken O, Vermeersch H, Joossen I, Van Eetvelde J, Schlee W, Marneffe W, Luyten J, Gilles A, Michiels S. Cost-effectiveness of a smartphone Application for Tinnitus Treatment (the CATT trial): a study protocol of a randomised controlled trial. Trials. 2022 May 23;23(1):435. doi: 10.1186/s13063-022-06378-7.

  PMID: 35606823 DERIVED

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

Central Study Contacts

Sarah Michiels, PhD

CONTACT

+3211269307; sarah.michiels@uhasselt.be

Annick Gilles, PhD

CONTACT

+3238215280; annick.gilles@uza.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study patients will be blinded towards the group they will be randomised to, but the therapist cannot be blinded, as she knows whether a patient receives the treatment every week or every two weeks. To limit the risk of bias related to lack of blinding of the therapist, all evaluation measurements will be performed by a blinded assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: The study is designed as a single-blind two-arm 1:1 randomised controlled trial. The study is designed as a non-inferiority trial of a continuous response variable comparing independent control and experimental subjects. After baseline measurements, patients will be randomised into either the experimental group or the control group. A stratified randomisation according to the grade of tinnitus severity obtained by use of the Tinnitus Functional Index (TFI) and gender will be used. A minimisation procedure will be used to perform the stratified randomisation using the web-based online randomisation tool Qminim.

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 17, 2022
• Study Start: March 1, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)