Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02655575 |
| Other study ID # |
2014/921 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2015 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
April 2022 |
| Source |
Bergen University College |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
