An interventional study of BI + VR + CBT and BI + phone calls in Dizziness, Vertigo and Vestibular Neuritis, sponsored by Bergen University College. Completed at 1 site in Norway. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Bergen University College · Not applicable, Interventional, and Treatment
Brief Summary:
The purpose of the present study is to examine the effects of a Group based intervention consisting of vestibular rehabilitation (VR) combined with cognitive behavioral therapy (CBT) in patients with long--lasting vestibular dizziness. The study also aims to describe sociodemographic, physical and psychological characteristics in the patients, and to examine prognostic factors related to functional status and disability following participation in the intervention.
Prior to the RCT, a feasibility study will be conducted to examine the feasibility of the study protocol.
Dizziness is a common complaint. International studies show a prevalence of balance/dizziness problems in 10-30% in the population, and in Norway it is reported that 11 % of the population have symptoms of dizziness and/or imbalance during the last three months. Peripheral vestibular disorders are the most common cause of dizziness presenting in primary care. Most people recover within a few weeks , but it is assumed that about 30% of the patients do not recover fully from an acute peripheral vestibular disorder and develop long-lasting dizziness, often with secondary musculoskeletal pain and anxiety, making it a multifactorial syndrome. It is unknown if these secondary complaints are issues that maintain or exacerbates the dizziness, or if a high level of musculoskeletal and psychological problems may predict future disability.There is a general consensus that exercises labeled as Vestibular Rehabilitation (VR) is the most effective treatment for vestibular dysfunction. VR exercises involve eye, head and body movements aiming to provoke dizziness, which is a prerequisite for adaptation and recovery. However, not all patients will recover from VR, and therefore increased attention toward the psychological aspects, targeting how patients think about the dizziness has been addressed. Cognitive behavioral therapy (CBT) alone or in addition to VR seems to have limited effect. This present study aims to combine an existing group treatment targeting body awareness and VR with CBT in order to address both the movement provoked dizziness and secondary complaints that patients with long-term dizziness often present with.
Prior to conducting the RCT the feasibility of recruitment procedures, test procedures and the interventions (CBT-VR and BI) will be examined in a feasibility study. The study is judged as feasible if the participants could complete the testing and adhere to the treatment protocols, of they found the intervention appropriate for their complaints, and if the primary outcomes improved following the intervention. Eight participants were planned for the study.
226 studies on the registry are indexed under Dizziness; 56 are open to participants now.
This study's enrollment of 107 is above the median of 43 across 170 interventional studies indexed under Dizziness.
Browse Dizziness studies →Bergen University College is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brief Intervention (BI) consists of an individual clinical examination, education/information and advice about being active Vestibular Rehabilitation (VR) includes active exercises that provokes dizziness, Balance exercises and body awareness exercises in a group format. Cognitive Behavioral Therapy (CBT) includes conversation and reflection about factors that may be a barrier to Activity and participation
Behavioral: BI + VR + CBT · Behavioral: BI + phone calls
Brief Intervention (BI) consists of an individual clinical examination, education/information and advice about being active Phone Calls as follow-up at week 2 and 6 to reassure
Behavioral: BI + VR + CBT · Behavioral: BI + phone calls
Brief intervention (information and advice) + group-based vestibular rehabilitation combined with cognitive behavioral therapy
Also known as: Brief intervention (BI), Vestibular rehabilitation (VR), Cognitive behavioral therapy (CBT)
Brief intervention (information and advice). Patients are followed-up by phone calls
Also known as: Brief intervention (BI)
Dizziness Handicap Inventory (DHI)
Time frame: 3 min
6 m walking test preferred velocity
6 meter walking distance (preferred velocity) measured in Seconds. Mean of two trials
Time frame: 5 min
Vertigo symptom scale (VSS-SF)
Time frame: 3 min
Patient Specific Functional Scale (PSFS)
Time frame: 3 min
Subjective Health Complaints (SHC)
Time frame: 3 min
Body Sensation Questionnaire (BSQ)
Time frame: 3 min
Mobility Index (MI-A)
Time frame: 3 min
Panic Attack Scale (PAS)
Time frame: 3 min
EQ-5D-5L
Time frame: 2 min
Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 min
Global Muscle Examination (GME) - flexibility
Time frame: 6 min
Patient Global Impression of Change
Time frame: 1 min
Dynamic Visual Aquity Test (DVA)
Time frame: 2 min
Hand Grip test
Time frame: 2 min
6 m walking test (as fast as possible), mean of two test trials
walk 6 meter as fast as possible
Time frame: 3 min
Dual task waling test, 6 m
6 meter walking test, optional speed, while doing a cognitive task
Time frame: 3 min
Perceived dizziness before and after 1 min head movements
Time frame: 2 min
The Modified Clinical Test for Sensory Interaction and Balance (mCTSIB) 192 (mCTSIB) test
Time frame: 4 min
Chalder Fatigue Scale (CFS)
Time frame: 1 min
Limits of stability (LOS)
Time frame: 2
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Bergen University College