Somatoform Vertigo/Dizziness Clinical Trial
Official title:
Tailored Care for Somatoform Vertigo/Dizziness - From Diagnostics to Therapy
The purpose of this study is to evaluate the efficacy of a manualised, multimodal group psychotherapy, based on integrative psychotherapy (IPT) and tailored to somatoform vertigo/dizziness (SVD) subgroups of mental disorders, compared to self-help groups (SHGs) in patients with SVD. The investigators hypothesise that patients who received IPT will demonstrate greater improvement concerning their vertigo-related handicap compared to patients from the SHGs. The investigators will also analyse the cost-effectiveness of experimental and control intervention.
Vertigo/dizziness (VD) is one of the most frequent problems in medicine with a one-year
prevalence of 23%. Approximately 50% of the complex VD disorders (i.e., VD is the cardinal
symptom and persists > 6 months) are not fully explained by an identifiable medical
condition and could be labelled as somatoform vertigo/dizziness (SVD), fulfilling the
criteria of somatoform disorder according to ICD-10 or DSM-IV, respectively. SVD shows a
high comorbidity rate of other mental disorders, such as anxiety/phobic and depressive
disorders. The majority of the patients with SVD suffer severe impairments in their daily
and working lives and report a poorer quality of life compared to the patients with organic
VD. Although preliminary evidence indicates that psychotherapy may be effective in these
patients, the therapeutic options in the treatment of SVD remain unsatisfactory.
In this two-armed, single-centre, randomised, controlled, open superiority clinical trial,
the long-term efficacy of manualised, multimodal group psychotherapy, based on integrative
psychotherapy (IPT) and tailored to SVD subgroups of mental disorders will be investigated
in patients with SVD compared to self-help groups (SHGs). IPT describes a differentiated
psychotherapeutic approach, which combines different therapeutic techniques, such as
interpersonal skills and psychodynamic aspects, self-management and symptom management
skills, psychoeducation, and relaxation techniques. Within this study, IPT is tailored to
SVD including its common mental comorbidity.
Patients will be recruited via routine care appointments at the German Centre for Vertigo
and Balance Disorders, a specialised tertiary care unit at the Klinikum Großhadern
(Ludwig-Maximilians-Universitaet, Munich).
Our principal research questions are as follows: Will IPT result in a clinically relevant
improvement in vertigo/dizziness-related quality of life? Does this long-term improvement
also apply to associated mental symptoms, such as depression, anxiety and somatisation, as
well as balance strategies measured by posturography? Is IPT in the long term superior to
moderated SVD-SHGs? The investigators hypothesise that the patients who received IPT will
demonstrate greater improvement concerning their vertigo-related handicap compared to the
patients from the SHGs. The investigators will also analyse the cost-effectiveness of this
trial.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment