Assessment and Treatment of Patients With Long-term Dizziness in Primary Care
LODIP
1 other identifier
interventional
107
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 10, 2015
CompletedFirst Posted
Study publicly available on registry
January 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedFebruary 5, 2025
February 1, 2025
6.7 years
November 10, 2015
February 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (18)
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
- +13 more secondary outcomes
Study Arms (2)
BI + VR + CBT
EXPERIMENTALBrief 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
BI + phone calls
ACTIVE COMPARATORBrief 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
Interventions
Brief intervention (information and advice) + group-based vestibular rehabilitation combined with cognitive behavioral therapy
Brief intervention (information and advice). Patients are followed-up by phone calls
Eligibility Criteria
You may qualify if:
- The dizziness is provoked or aggravated by head movements, more than 3 months duration og symptoms, the dizziness started acute, understand Norwegian
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bergen University Collegelead
- University of Bergencollaborator
- Norwegian Fund for Postgraduate Training in Physiotherapycollaborator
- University of Southern Denmarkcollaborator
- Duke Universitycollaborator
- Haukeland University Hospitalcollaborator
Study Sites (1)
Bergen University College
Bergen, 5020, Norway
Related Publications (2)
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.
PMID: 31590692DERIVEDKristiansen 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.
PMID: 31139431DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gro AF Flaten, ph.d.
Bergen University College
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor, ph.d.
Study Record Dates
First Submitted
November 10, 2015
First Posted
January 14, 2016
Study Start
October 1, 2015
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
February 5, 2025
Record last verified: 2025-02