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Tailored Care for Somatoform Vertigo/Dizziness

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02320851
Enrollment
216
Registered
2014-12-19
Start date
2015-01-31
Completion date
2017-10-31
Last updated
2014-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Somatoform Vertigo/Dizziness

Keywords

Somatoform disorder, Functional vertigo/dizziness, Chronic subjective dizziness

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.

Interventions

BEHAVIORALSVD-tailored Integrative Psychotherapy (IPT)

(see description of corresponding study arm)

BEHAVIORALSelf-help group (SHG)

(see description of corresponding study arm)

Sponsors

German Center for Vertigo and Balance Disorders
CollaboratorOTHER
Technical University of Munich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Vertigo-related quality of lifeImprovement 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.

Secondary

MeasureTime frameDescription
Generic quality of lifeImprovement at follow-up (12 months after treatment)Generic quality of life will be measured using the Quality of Life Questionnaire (EQ-5D).
Severity of vertigoImprovement at follow-up (12 months after treatment)Severity of vertigo will be measured using the Vertigo Symptom Scale (VSS).
DepressionImprovement at follow-up (12 months after treatment)Depression will be measured using the Beck Depression Inventory (BDI-II).
SomatisationImprovement 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 TestImprovement 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.
AnxietyImprovement at follow-up (12 months after treatment)Anxiety will be measured using the Beck Anxiety Inventory (BAI).

Other

MeasureTime frameDescription
Cost-effectivenessBaseline and follow-up (12 months after treatment)Cost-effectiveness will be measured as quality-adjusted life years (QALYs) derived from the EQ-5D at baseline and at 12 months after the 16-week therapy sessions. Costs related to absence from work and health care utilisation will be obtained using a modified German version of the Trimbos/iMTA questionnaire for costs associated with Psychiatric Illness (TiC-P).

Contacts

Primary ContactGabriele Schmid, Dr. phil. Dipl.-Psych.
g.schmid@tum.de+49 (0)89 4140 4398
Backup ContactKatharina Radziej, Dipl.-Psych.
k.radziej@tum.de+49 (0)89 4140 4398

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026