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Tailored Care for Somatoform Vertigo/Dizziness

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ClinicalTrials.gov Identifier: NCT02320851
Recruitment Status : Unknown
Verified December 2014 by Technische Universität München.
Recruitment status was:  Not yet recruiting
First Posted : December 19, 2014
Last Update Posted : December 19, 2014
Sponsor:
Collaborator:
German Center for Vertigo and Balance Disorders
Information provided by (Responsible Party):
Technische Universität München

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.

Condition or disease Intervention/treatment Phase
Somatoform Vertigo/Dizziness Behavioral: SVD-tailored Integrative Psychotherapy (IPT) Behavioral: Self-help group (SHG) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tailored Care for Somatoform Vertigo/Dizziness - From Diagnostics to Therapy
Study Start Date : January 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SVD-tailored Integrative Psychotherapy (IPT)
IPT is a short-term psychotherapy aiming to ameliorate both physical and psychosocial distress. It emanates from a multidirectional and dynamic relationship among body, mind, and environment irrespective of causality. In a multi-component approach, other elements are integrated into it, such as cognitive-behavioral and psychodynamic techniques, psychoeducation and body-oriented techniques. The IPT intervention tailored to SVD will be delivered for 16 weeks in a manualised setting with one group session per week (à 90 minutes) and one additional booster session three months after the end of the therapy. The group psychotherapy is on a 6-8:1 basis and will be conducted by a psychotherapist trained on the basis of the manual and under regular clinical supervision.
Behavioral: SVD-tailored Integrative Psychotherapy (IPT)
(see description of corresponding study arm)

Active Comparator: Self-help group (SHG)
The experimental condition will be compared to moderated self-help groups without the implementation of additional therapeutic interventions. Those can be classified as low-level non-placebo control. Treatment will consist of 16 weekly moderated SHG sessions (one weekly session à 90 minutes) and one additional booster-session at three months after the end of the control intervention to be delivered on a 6-8:1 basis by a trained SHG moderator under clinical supervision.
Behavioral: Self-help group (SHG)
(see description of corresponding study arm)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. Depression [ Time Frame: Improvement at follow-up (12 months after treatment) ]
    Depression will be measured using the Beck Depression Inventory (BDI-II).

  4. Anxiety [ Time Frame: Improvement at follow-up (12 months after treatment) ]
    Anxiety will be measured using the Beck Anxiety Inventory (BAI).

  5. Somatisation [ Time Frame: Improvement at follow-up (12 months after treatment) ]
    Somatisation will be measured using the Patient Health Questionnaire 15 (PHQ-15).

  6. 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.


Other Outcome Measures:
  1. Cost-effectiveness [ Time Frame: Baseline 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320851


Contacts
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Contact: Gabriele Schmid, Dr. phil. Dipl.-Psych. +49 (0)89 4140 4398 g.schmid@tum.de
Contact: Katharina Radziej, Dipl.-Psych. +49 (0)89 4140 4398 k.radziej@tum.de

Sponsors and Collaborators
Technische Universität München
German Center for Vertigo and Balance Disorders
Investigators
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Principal Investigator: Claas Lahmann, PD Dr. med. Department of Psychosomatic Medicine and Psychotherapy, Klinikum rechts der Isar, Technische Universitaet, Munich

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02320851     History of Changes
Other Study ID Numbers: 01EO1401
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014
Keywords provided by Technische Universität München:
Somatoform disorder
Functional vertigo/dizziness
Chronic subjective dizziness
Additional relevant MeSH terms:
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Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders