Tailored Care for Somatoform Vertigo/Dizziness

Somatoform Vertigo/Dizziness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02320851
• Other study ID #: 01EO1401
• Status: Not yet recruiting
• Phase: N/A
• First received: December 16, 2014
• Last updated: December 18, 2014
• Start date: January 2015
• Est. completion date: October 2017

Study information

• Verified date: December 2014
• Source: Technische Universität München
• Contact: Gabriele Schmid, Dr. phil. Dipl.-Psych.
• Phone: +49 (0)89 4140 4398
• Email: g.schmid[@]tum.de
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: October 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dizziness
• Somatoform Vertigo/Dizziness
• Vertigo

Intervention

Behavioral:
• SVD-tailored Integrative Psychotherapy (IPT)
(see description of corresponding study arm)
• Self-help group (SHG)
(see description of corresponding study arm)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität München	German Centre for Vertigo and Balance Disorders, Ludwig-Maximilians-Universitaet

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost-effectiveness	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).	Baseline and follow-up (12 months after treatment)	No
Primary	Vertigo-related quality of life	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.	Improvement at follow-up (12 months after treatment)	No
Secondary	Generic quality of life	Generic quality of life will be measured using the Quality of Life Questionnaire (EQ-5D).	Improvement at follow-up (12 months after treatment)	No
Secondary	Severity of vertigo	Severity of vertigo will be measured using the Vertigo Symptom Scale (VSS).	Improvement at follow-up (12 months after treatment)	No
Secondary	Depression	Depression will be measured using the Beck Depression Inventory (BDI-II).	Improvement at follow-up (12 months after treatment)	No
Secondary	Anxiety	Anxiety will be measured using the Beck Anxiety Inventory (BAI).	Improvement at follow-up (12 months after treatment)	No
Secondary	Somatisation	Somatisation will be measured using the Patient Health Questionnaire 15 (PHQ-15).	Improvement at follow-up (12 months after treatment)	No
Secondary	Computerized Static Posturography and Head Impulse Test	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.	Improvement at follow-up (12 months after treatment)	No