Clinical Trial: Tailored Care for Somatoform Vertigo/Dizziness

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Tailored Care for Somatoform Vertigo/Dizziness - From Diagnostics to Therapy

Brief Summary: 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.

Detailed Summary:

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 a
Sponsor: Technische Universität München

Current Primary Outcome: Vertigo-related quality of life [ Time Frame: Improvement at follow-up (12 months after treatment) ]

Absolute improvement of vertigo-related quality of life on the Vertigo Handicap Questionnaire (VHQ) at 12 months after the 16-week therapy sessions from VHQ at randomisation/baseline.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Generic quality of life [ Time Frame: Improvement at follow-up (12 months after treatment) ]
    Generic quality of life will be measured using the Quality of Life Questionnaire (EQ-5D).
  • Severity of vertigo [ Time Frame: Improvement at follow-up (12 months after treatment) ]
    Severity of vertigo will be measured using the Vertigo Symptom Scale (VSS).
  • Depression [ Time Frame: Improvement at follow-up (12 months after treatment) ]
    Depression will be measured using the Beck Depression Inventory (BDI-II).
  • Anxiety [ Time Frame: Improvement at follow-up (12 months after treatment) ]
    Anxiety will be measured using the Beck Anxiety Inventory (BAI).
  • Somatisation [ Time Frame: Improvement at follow-up (12 months after treatment) ]
    Somatisation will be measured using the Patient Health Questionnaire 15 (PHQ-15).
  • Computerized Static Posturography and Head Impulse Test [ Time Frame: Improvement at follow-up (12 months after treatment) ]
    Both assessments (Computerized Static Posturography and Head Impulse Test) are introduced as state-of-the-art validated objective dimensions that address relevant core elements of the study conditions and allow for the estimation of possible intervention effects independent from the patients' self-reported outcomes.


Original Secondary Outcome: Same as current

Information By: Technische Universität München

Dates:
Date Received: December 16, 2014
Date Started: January 2015
Date Completion: October 2017
Last Updated: December 18, 2014
Last Verified: December 2014