Clinical trial NCT02320851: Tailored Care for Somatoform Vertigo/Dizziness
Official title: Tailored Care for Somatoform Vertigo/Dizziness - From Diagnostics to Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Somatoform Vertigo/Dizziness
Keywords: Somatoform disorder
Functional vertigo/dizziness
Chronic subjective dizziness
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: German Center for Vertigo and Balance Disorders
First posted: 2014-12-19
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* SVD diagnosis
* Clinically relevant SVD (VHQ sum score \> 45)
* Informed consent

Exclusion Criteria:

* Insufficient German language ability
* Insufficient cognitive abilities (Mini Mental State Test (MMST) ≤ 27)
* Severe and chronic comorbid somatic or mental disease (e.g., suicidality, severe depression, drug addiction)
* Current psychotherapeutic treatment
* Living \> 50 km away from Munich

Primary outcomes:
measure: Vertigo-related quality of life
timeFrame: Improvement at follow-up (12 months after treatment)
Secondary outcomes:
measure: Generic quality of life
timeFrame: Improvement at follow-up (12 months after treatment)
measure: Severity of vertigo
timeFrame: Improvement at follow-up (12 months after treatment)
measure: Depression
timeFrame: Improvement at follow-up (12 months after treatment)
measure: Anxiety
timeFrame: Improvement at follow-up (12 months after treatment)
measure: Somatisation
timeFrame: Improvement at follow-up (12 months after treatment)
measure: Computerized Static Posturography and Head Impulse Test
timeFrame: Improvement at follow-up (12 months after treatment)
Other outcomes:
measure: Cost-effectiveness
timeFrame: Baseline and follow-up (12 months after treatment)
Locations:
Study officials:
affiliation: Department of Psychosomatic Medicine and Psychotherapy, Klinikum rechts der Isar, Technische Universitaet, Munich
name: Claas Lahmann, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Limburg K, Radziej K, Sattel H, Henningsen P, Dieterich M, Probst T, Dale R, Lahmann C. A Randomized Controlled Trial Evaluating Integrative Psychotherapeutic Group Treatment Compared to Self-Help Groups in Functional Vertigo/Dizziness. J Clin Med. 2021 May 20;10(10):2215. doi: 10.3390/jcm10102215.
citation: Lahmann C, Henningsen P, Dieterich M, Radziej K, Schmid G. Tailored care for somatoform vertigo/dizziness: study protocol for a randomised controlled trial evaluating integrative group psychotherapy. J Neurol. 2015 Aug;262(8):1867-75. doi: 10.1007/s00415-015-7784-6. Epub 2015 May 23.