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

Primary Purpose

Dizziness, Vertigo, Vestibular Neuritis

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
BI + VR + CBT
BI + phone calls
Sponsored by
Bergen University College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dizziness focused on measuring dizziness, cognitive therapy, primary care, vestibular rehabilitation, chronic

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bergen University College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BI + VR + CBT

BI + phone calls

Arm Description

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

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

Outcomes

Primary Outcome Measures

Dizziness Handicap Inventory (DHI)
6 m walking test preferred velocity
6 meter walking distance (preferred velocity) measured in Seconds. Mean of two trials

Secondary Outcome Measures

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

Full Information

First Posted
November 10, 2015
Last Updated
April 21, 2022
Sponsor
Bergen University College
Collaborators
University of Bergen, Norwegian Fund for Postgraduate Training in Physiotherapy, University of Southern Denmark, Duke University, Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02655575
Brief Title
Assessment and Treatment of Patients With Long-term Dizziness in Primary Care
Acronym
LODIP
Official Title
Assessment and Treatment of Patients With Long-term Dizziness in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2015 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bergen University College
Collaborators
University of Bergen, Norwegian Fund for Postgraduate Training in Physiotherapy, University of Southern Denmark, Duke University, Haukeland University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dizziness, Vertigo, Vestibular Neuritis
Keywords
dizziness, cognitive therapy, primary care, vestibular rehabilitation, chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI + VR + CBT
Arm Type
Experimental
Arm Description
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
Arm Title
BI + phone calls
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
BI + VR + CBT
Other Intervention Name(s)
Brief intervention (BI), Vestibular rehabilitation (VR), Cognitive behavioral therapy (CBT)
Intervention Description
Brief intervention (information and advice) + group-based vestibular rehabilitation combined with cognitive behavioral therapy
Intervention Type
Behavioral
Intervention Name(s)
BI + phone calls
Other Intervention Name(s)
Brief intervention (BI)
Intervention Description
Brief intervention (information and advice). Patients are followed-up by phone calls
Primary Outcome Measure Information:
Title
Dizziness Handicap Inventory (DHI)
Time Frame
3 min
Title
6 m walking test preferred velocity
Description
6 meter walking distance (preferred velocity) measured in Seconds. Mean of two trials
Time Frame
5 min
Secondary Outcome Measure Information:
Title
Vertigo symptom scale (VSS-SF)
Time Frame
3 min
Title
Patient Specific Functional Scale (PSFS)
Time Frame
3 min
Title
Subjective Health Complaints (SHC)
Time Frame
3 min
Title
Body Sensation Questionnaire (BSQ)
Time Frame
3 min
Title
Mobility Index (MI-A)
Time Frame
3 min
Title
Panic Attack Scale (PAS)
Time Frame
3 min
Title
EQ-5D-5L
Time Frame
2 min
Title
Hospital Anxiety and Depression Scale (HADS)
Time Frame
3 min
Title
Global Muscle Examination (GME) - flexibility
Time Frame
6 min
Title
Patient Global Impression of Change
Time Frame
1 min
Title
Dynamic Visual Aquity Test (DVA)
Time Frame
2 min
Title
Hand Grip test
Time Frame
2 min
Title
6 m walking test (as fast as possible), mean of two test trials
Description
walk 6 meter as fast as possible
Time Frame
3 min
Title
Dual task waling test, 6 m
Description
6 meter walking test, optional speed, while doing a cognitive task
Time Frame
3 min
Title
Perceived dizziness before and after 1 min head movements
Time Frame
2 min
Title
The Modified Clinical Test for Sensory Interaction and Balance (mCTSIB) 192 (mCTSIB) test
Time Frame
4 min
Title
Chalder Fatigue Scale (CFS)
Time Frame
1 min
Title
Limits of stability (LOS)
Time Frame
2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gro AF Flaten, ph.d.
Organizational Affiliation
Bergen University College
Official's Role
Study Director
Facility Information:
Facility Name
Bergen University College
City
Bergen
ZIP/Postal Code
5020
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
31590692
Citation
Kristiansen L, Magnussen LH, Wilhelmsen KT, Maeland S, Nordahl SHG, Clendaniel R, Hovland A, Juul-Kristensen B. Efficacy of intergrating vestibular rehabilitation and cognitive behaviour therapy in persons with persistent dizziness in primary care- a study protocol for a randomised controlled trial. Trials. 2019 Oct 7;20(1):575. doi: 10.1186/s13063-019-3660-5.
Results Reference
derived
PubMed Identifier
31139431
Citation
Kristiansen L, Magnussen LH, Juul-Kristensen B, Maeland S, Nordahl SHG, Hovland A, Sjobo T, Wilhelmsen KT. Feasibility of integrating vestibular rehabilitation and cognitive behaviour therapy for people with persistent dizziness. Pilot Feasibility Stud. 2019 May 20;5:69. doi: 10.1186/s40814-019-0452-3. eCollection 2019.
Results Reference
derived

Learn more about this trial

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

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