DizzinessLODIPNCT02655575
Assessment and Treatment of Patients With Long-term Dizziness in Primary Care
A study testing BI + VR + CBT and BI + phone calls in people with Dizziness and Vertigo, run by Bergen University College at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dizziness, Vertigo, Vestibular Neuritis
- What is being tested?
- BI + VR + CBT and BI + phone calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2015to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The dizziness is provoked or aggravated by head movements, more than 3 months duration og symptoms, the dizziness started acute, understand Norwegian
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dizziness, Vertigo, Vestibular Neuritis
- Being tested
- BI + VR + CBT, BI + phone calls
- Keywords
- dizziness, cognitive therapy, primary care, vestibular rehabilitation, chronic
- Medical subject headings
- Dizziness, Vertigo, Vestibular Neuronitis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI + VR + CBTBehavioural
Also called Brief intervention (BI), Vestibular rehabilitation (VR), Cognitive behavioral therapy (CBT)
Brief intervention (information and advice) + group-based vestibular rehabilitation combined with cognitive behavioral therapy
BI + phone callsBehavioural
Also called Brief intervention (BI)
Brief intervention (information and advice). Patients are followed-up by phone calls
| Study group | Role | What they receive |
|---|---|---|
| BI + VR + CBT | Experimental | 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 Receives: Behavioral: BI + VR + CBT; Behavioral: BI + phone calls |
| BI + phone calls | Active comparator | 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 Receives: Behavioral: BI + VR + CBT; Behavioral: BI + phone calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dizziness Handicap Inventory (DHI)
Measured: 3 min
6 m walking test preferred velocity
6 meter walking distance (preferred velocity) measured in Seconds. Mean of two trials
Measured: 5 min
Secondary outcomes (18)
Vertigo symptom scale (VSS-SF)
Measured: 3 min
Patient Specific Functional Scale (PSFS)
Measured: 3 min
Subjective Health Complaints (SHC)
Measured: 3 min
Body Sensation Questionnaire (BSQ)
Measured: 3 min
Mobility Index (MI-A)
Measured: 3 min
Panic Attack Scale (PAS)
Measured: 3 min
EQ-5D-5L
Measured: 2 min
Hospital Anxiety and Depression Scale (HADS)
Measured: 3 min
Global Muscle Examination (GME) - flexibility
Measured: 6 min
Patient Global Impression of Change
Measured: 1 min
Dynamic Visual Aquity Test (DVA)
Measured: 2 min
Hand Grip test
Measured: 2 min
6 m walking test (as fast as possible), mean of two test trials
walk 6 meter as fast as possible
Measured: 3 min
Dual task waling test, 6 m
6 meter walking test, optional speed, while doing a cognitive task
Measured: 3 min
Perceived dizziness before and after 1 min head movements
Measured: 2 min
The Modified Clinical Test for Sensory Interaction and Balance (mCTSIB) 192 (mCTSIB) test
Measured: 4 min
Chalder Fatigue Scale (CFS)
Measured: 1 min
Limits of stability (LOS)
Measured: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startOct 2015
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DizzinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bergen University College
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, Norwegian Fund for Postgraduate Training in Physiotherapy, University of Southern Denmark, Duke University, Haukeland University Hospital
- Responsible party
- Principal investigator, Liv Heide Magnussen, Bergen University College
- Investigators
- Gro AF Flaten, ph.d., Study director, Bergen University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655575
- Sponsor's protocol ID
- 2014/921
- Acronym
- LODIP
- Status last verified
- Feb 2025
- First submitted
- 10 Nov 2015
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31590692Kristiansen 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.
PubMed 31139431
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Treatment of Patients With Long-term Dizziness in Primary Care
- ClinicalTrials.gov ID
- NCT02655575
- Acronym / sponsor ID
- LODIP / 2014/921
- Conditions
- Dizziness, Vertigo, Vestibular Neuritis
- Keywords
- dizziness, cognitive therapy, primary care, vestibular rehabilitation, chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Bergen University CollegeUniversity, hospital or other
- Collaborators
- University of Bergen, Norwegian Fund for Postgraduate Training in Physiotherapy, University of Southern Denmark, Duke University, Haukeland University Hospital
- Study start
- Oct 2015 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI + VR + CBT | Experimental | Behavioral: BI + VR + CBT, Behavioral: BI + phone callsBrief 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 comparator | Behavioral: BI + VR + CBT, Behavioral: BI + phone callsBrief 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The dizziness is provoked or aggravated by head movements, more than 3 months duration og symptoms, the dizziness started acute, understand Norwegian
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI + VR + CBTAlso: Brief intervention (BI), Vestibular rehabilitation (VR), Cognitive behavioral therapy (CBT)Brief intervention (information and advice) + group-based vestibular rehabilitation combined with cognitive behavioral therapy | Behavioural | BI + VR + CBT, BI + phone calls |
| BI + phone callsAlso: Brief intervention (BI)Brief intervention (information and advice). Patients are followed-up by phone calls | Behavioural | BI + VR + CBT, BI + phone calls |
Primary outcome
Dizziness Handicap Inventory (DHI)
Time frame: 3 min
6 m walking test preferred velocity
Time frame: 5 min
6 meter walking distance (preferred velocity) measured in Seconds. Mean of two trials
18 secondary outcomes
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
Time frame: 3 min
Dual task waling test, 6 m
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Derived from this study: PubMed 31590692Kristiansen 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.
- Derived from this study: PubMed 31139431Kristiansen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gro AF Flaten, ph.d. study director
Bergen University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BI + VR + CBT and BI + phone calls in people with Dizziness and Vertigo, run by Bergen University College at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dizziness Handicap Inventory (DHI) (time frame: 3 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02655575, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.