Assessment and Treatment of Patients With Long-term Dizziness in Primary Care

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment and Treatment of Patients With Long-term Dizziness in Primary Care

Conditions
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Dizziness, Vertigo, Vestibular Neuritis

Intervention / Treatment
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* Behavioral: BI + VR + CBT
* Behavioral: BI + phone calls


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The dizziness is provoked or aggravated by head movements, more than 3 months duration og symptoms, the dizziness started acute, understand Norwegian Exclusion Criteria: Dizziness no longer a problem, other known reasons, than vestibular, for the dizziness (neurological, psychological, or cancer), fluctuating vestibular disease (e.g, ménières disease), scheduled for treatment of/ have had treatment for benign paroxysmal positional vertigo within one month,conditions where fast head movements are contraindicated (e.g. osteoporosis of the neck, whiplash associated injuries), participated in group therapy for dizziness within the past year, unable to attend test and treatment locations

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI + VR + CBT<br>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<br>* Brief intervention (information and advice) + group-based vestibular rehabilitation combined with cognitive behavioral therapy<br>* Other names: Cognitive behavioral therapy (CBT);Behavioral: BI + phone calls<br>* Brief intervention (information and advice). Patients are followed-up by phone calls<br>* Other names: Brief intervention (BI);|
| Active Comparator: BI + phone calls<br>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<br>* Brief intervention (information and advice) + group-based vestibular rehabilitation combined with cognitive behavioral therapy<br>* Other names: Cognitive behavioral therapy (CBT);Behavioral: BI + phone calls<br>* Brief intervention (information and advice). Patients are followed-up by phone calls<br>* Other names: Brief intervention (BI);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dizziness Handicap Inventory (DHI) |  | 3 min | 
| 6 m walking test preferred velocity | 6 meter walking distance (preferred velocity) measured in Seconds. Mean of two trials | 5 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertigo symptom scale (VSS-SF) |  | 3 min | 
| Patient Specific Functional Scale (PSFS) |  | 3 min | 
| Subjective Health Complaints (SHC) |  | 3 min | 
| Body Sensation Questionnaire (BSQ) |  | 3 min | 
| Mobility Index (MI-A) |  | 3 min | 
| Panic Attack Scale (PAS) |  | 3 min | 
| EQ-5D-5L |  | 2 min | 
| Hospital Anxiety and Depression Scale (HADS) |  | 3 min | 
| Global Muscle Examination (GME) - flexibility |  | 6 min | 
| Patient Global Impression of Change |  | 1 min | 
| Dynamic Visual Aquity Test (DVA) |  | 2 min | 
| Hand Grip test |  | 2 min | 
| 6 m walking test (as fast as possible), mean of two test trials | walk 6 meter as fast as possible | 3 min | 
| Dual task waling test, 6 m | 6 meter walking test, optional speed, while doing a cognitive task | 3 min | 
| Perceived dizziness before and after 1 min head movements |  | 2 min | 
| The Modified Clinical Test for Sensory Interaction and Balance (mCTSIB) 192 (mCTSIB) test |  | 4 min | 
| Chalder Fatigue Scale (CFS) |  | 1 min | 
| Limits of stability (LOS) |  | 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dizziness, cognitive therapy, primary care, vestibular rehabilitation, chronic